NCT04143035

Brief Summary

"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU. Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours. The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken. Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled. This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

247 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

October 19, 2019

Last Update Submit

October 20, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • ICU Mortality

    Overall ICU Mortality due to septic shock with hypotension

    throughout ICU stay till discharge (up to 2 months)

  • Completing the elements of the one hour SSC sepsis bundle in one 1 hour

    Identify factors associated with improved outcomes and fulfilling the goals of the one hour Surviving Sepsis Campaign (SSC) bundles within one, three and six hours in patients with sepsis and septic shock and to identify compliance with the one hour SSC bundle guidelines The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg

    1 hour after admission upto 60 days from the study start date in respective study site (60 days)

Secondary Outcomes (3)

  • Hospital mortality

    throughout the hospital stay till discharge in the respective study site (up to 3 months)

  • 28-day mortality

    From ICU admission to 28 days in the respective study site (up to 3 months)

  • Completing the elements of the one hour SSC sepsis bundle in one, three and six hours

    1 hour, 3 hour and six hour after admission upto 60 days from the study start date in the respective study site (60 days )

Interventions

No Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients presenting to ICU with suspected sepsis and hypotension

You may qualify if:

  • Adult patients (≥ 18 years old)
  • Presenting to ICU with suspected sepsis
  • Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP \> 90 mmHg / MAP \>65mmHg on vasopressor.

You may not qualify if:

  • Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic or hemorrhagic shock)
  • Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
  • Patient transferred from another ICU OR another hospital (only if stay \>7 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (247)

AIIMS Patna

Patna, Bihar, India

Location

All india institute of medical sciences

Patna, Bihar, India

Location

Anant Institute of Medical Sciences

Jabalpur, Madhya Pradesh, India

Location

Breach Candy Hospital Trust

Mumbai, Maharashtra, India

Location

Criticare Hospital and Research Institute

Nagpur, Maharashtra, India

Location

Galaxy care hospital

Pune, Maharashtra, India

Location

Sanjeevan Hospital

Pune, Maharashtra, India

Location

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

Location

Eternal Hospital

Jaipur, Rajasthan, India

Location

Kamlesh Kanwar Shekhawat

Udaipur, Rajasthan, India

Location

Pims

Udaipur, Rajasthan, India

Location

Sarvodaya hospital and research centre

Farīdābād, Uttar Pradesh, India

Location

Fortune Hospital

Kanpur, Uttar Pradesh, India

Location

Sir Sundar lal Hospital, IMS, BHU, Varanasi

Varanasi, Uttar Pradesh, India

Location

Sir Sunderlal Hospital

Varanasi, Uttar Pradesh, India

Location

Nayati Hospital - Trauma & Acute Care Centre

Agra, India

Location

Purushottam das Savitri Devi Cancer center

Agra, India

Location

Pushpanjali Hospital

Agra, India

Location

Rainbow Hospitals

Agra, India

Location

Saideep Healthcare and Research Pvt Ltd

Ahilyanagar, India

Location

Narayana Multispeciality Hospital

Ahmedabad, India

Location

Sterling hospital

Ahmedabad, India

Location

Zydus Hospitals Ahmedabad

Ahmedabad, India

Location

J N Medical College & Hospital

Aligarh, India

Location

Ohm Trauma centre and critical care

Aligarh, India

Location

Emc hospital

Amritsar, India

Location

Fortis Escorts Hospital Amritsar

Amritsar, India

Location

Kamalnayan Bajaj hospital

Aurangabad, India

Location

Mgm Medical College Hospital and Medical Centre Research Institute(McRi)

Aurangabad, India

Location

Oriion Citicare Superspeciality Hospital

Aurangabad, India

Location

Shraddha hospital and critical care center

Aurangabad, India

Location

Bhagwan Mahaveer Jain Hospital

Bangalore, India

Location

Columbiaasia Referral Hospital, Yeshwantpur

Bangalore, India

Location

Cytecare Cancer Hospital

Bangalore, India

Location

Health care Global (HCG)

Bangalore, India

Location

Shifaa hospital

Bangalore, India

Location

Shri Ram Murti Smarak Institute of Medical Sciences

Bareilly, India

Location

Geeta Hospital and research centre

Barnagar, India

Location

Aster R V Hospital

Bengaluru, India

Location

Manipal hospital

Bengaluru, India

Location

Mazumdar Shaw Medical Center

Bengaluru, India

Location

Regal Hospital

Bengaluru, India

Location

St John's Medical College Hospital

Bengaluru, India

Location

Vydehi Institute of Medical Sciences and Research Centre

Bengaluru, India

Location

Apollo Hospitals

Bhubaneshwar, India

Location

Amri hospital ICU -1

Bhubaneswar, India

Location

AMRI Hospitals

Bhubaneswar, India

Location

Amri Hospital

Bhubaneswar, India

Location

Apollo Hospitals

Bhubaneswar, India

Location

Apollo Hospital

Bhubaneswar, India

Location

BR Life Kalinga Hispital

Bhubaneswar, India

Location

Care Hospitals

Bhubaneswar, India

Location

Care Hospital

Bhubaneswar, India

Location

Gudage Hospital

Bidar, India

Location

Apollo Hospital Icu-1

Bilāspur, India

Location

Apollo Hospital

Bilāspur, India

Location

Ayush Hospital

Bījāpur, India

Location

K.M.Memorial hospital and research centre

Bokāro, India

Location

PGIMER

Chandigarh, India

Location

Apollo Hospitals Enterprise limited

Chennai, India

Location

Billroth hospital

Chennai, India

Location

Dr.Rela Institute and Medical Centre

Chennai, India

Location

Mgm Healthcare Ltd.

Chennai, India

Location

Sri Ramachandra Hospital

Chennai, India

Location

Sri Ramchandra Medical Centre

Chennai, India

Location

Kovai Medical Center Hospital and Research

Coimbatore, India

Location

Royal Care Super Speciality Hospital

Coimbatore, India

Location

Ashwini Hospital

Cuttack, India

Location

Goodluck Hospital

Cuttack, India

Location

Scb Medical College and Hospital

Cuttack, India

Location

SCB Medical College

Cuttack, India

Location

Paras Global Hospital

Darbhanga, India

Location

Dharmshila Narayana Superspeciality Hospital

Delhi, India

Location

Dr. Ram Manohar Lohia Hospital ,New Delhi

Delhi, India

Location

Dr. Ram Manohar Lohia Hospital

Delhi, India

Location

kailash Hospital and heart Institute

Delhi, India

Location

Pushpawati Singhania Research Institute

Delhi, India

Location

Sir Ganga Ram Hospital

Delhi, India

Location

BKL Walawalkar Hospital

Dervān, India

Location

Muthukrishnan Periasamy

Erode, India

Location

Qrg Healthcity

Faridabad, India

Location

Yashoda super specialty hospital, kaushambi

Ghaziabad, India

Location

City Hospital

Gorakhpur, India

Location

Dr.Ramesh Cardiac and Multiplicity PVT LTD

Guntur, India

Location

GBR super speciality hospitals

Guntur, India

Location

Lalitha Super Specialities Hospital

Guntur, India

Location

Samistha Hospital and Research Institute

Guntur, India

Location

Apollo Hospitals Guwahati

Guwahati, India

Location

Apollo hospitals

Guwahati, India

Location

Ayursundra Superspecialty hospital

Guwahati, India

Location

Dispur Hospitals pvt Ltd

Guwahati, India

Location

Gnrc Hospitas, Dispur

Guwahati, India

Location

Health City

Guwahati, India

Location

Nemcare Hospital

Guwahati, India

Location

Medanta Medicity

Gūrgaon, India

Location

Medanta the medicity hospital

Gūrgaon, India

Location

Medanta the medicity

Gūrgaon, India

Location

Narayana Super Specialty Hospital

Gūrgaon, India

Location

VPS Medeor Hospital

Gūrgaon, India

Location

Santhi Hospital

Hosūr, India

Location

Aig Hospitals, Gachibowli

Hyderabad, India

Location

Apollo Health City ICU-1

Hyderabad, India

Location

Apollo health city

Hyderabad, India

Location

Aware Gleneagles Global Hospital

Hyderabad, India

Location

Care hospital and institute of medical sciences

Hyderabad, India

Location

Care hospitals banjara

Hyderabad, India

Location

CENTURY hospital

Hyderabad, India

Location

Century Super Speciality Hospital

Hyderabad, India

Location

Continental Hospitals

Hyderabad, India

Location

Gleneagles Global Hospital

Hyderabad, India

Location

Krishna Institute of Medical Sciences

Hyderabad, India

Location

Rainbow childrnes hospital

Hyderabad, India

Location

South Central Railway Hospital ICU-1

Hyderabad, India

Location

South Central Railway Hospital

Hyderabad, India

Location

Virinchi Hospital

Hyderabad, India

Location

Yashoda Hospital

Hyderabad, India

Location

Choithram hospital

Indore, India

Location

Dodeja Hospital

Jabalpur, India

Location

Apex Hospital

Jaipur, India

Location

Manipal hospital

Jaipur, India

Location

Shubh Hospital

Jaipur, India

Location

shrimann superspeciality hospital ICU-1

Jalandhar, India

Location

Shrimann Superspeciality Hospital

Jalandhar, India

Location

Kripa Critical Care and Trauma Centre

Jalgaon, India

Location

Smvd Narayana Superspeciality Hospital

Jammu, India

Location

Tata Main Hospital

Jamshedpur, India

Location

All India Institute of Medical Sciences, jodhpur

Jodhpur, India

Location

Ved Hospital

Kalyān, India

Location

Abha superspeciality hospital

Kanpur, India

Location

Regency hospital ltd tower 1

Kanpur, India

Location

Shree krishna hospital ICU-1

Karamsad, India

Location

Shree Krishna Hospital

Karamsad, India

Location

Sankalpa hospital

Khammam, India

Location

Amrita institute of Medical Sciences

Kochi, India

Location

MOSC Medical College

Kochi, India

Location

AMRI Hospital Mukundapur

Kolkata, India

Location

AMRI Hospital, DHAKURIA

Kolkata, India

Location

Apollo Gleneagles Hospital

Kolkata, India

Location

Bellevue Clinic

Kolkata, India

Location

Fortis Hospital Anandapur

Kolkata, India

Location

Institute of Neurosciences Kolkata

Kolkata, India

Location

Medica Superspecialty Hospital

Kolkata, India

Location

Peerless Hospitex Hospital and Research Center Limited

Kolkata, India

Location

Tata Medical Center

Kolkata, India

Location

Travancore medical college,medicity

Kollam, India

Location

Govt.Medical college

Kottayam, India

Location

King George's Medical University

Lucknow, India

Location

Christian Medical College

Ludhiana, India

Location

Apollo speciality hospital

Madurai, India

Location

Kasturba medical college, Manipal

Manipal, India

Location

Nayati medicity hospital

Mathura, India

Location

Manglam Hosp

Meerut, India

Location

Metro Hospital and heart Institute

Meerut, India

Location

Cheema Medical Complex

Mohali, India

Location

Fortis Hospital

Mohali, India

Location

MAX Superspecialty Hospital

Mohali, India

Location

Asian Cancer Institute

Mumbai, India

Location

Bhatia Hospital

Mumbai, India

Location

Dr L H HIRANANDANI HOSPITAL

Mumbai, India

Location

Fortis hiranandani hospital

Mumbai, India

Location

Fortis Hospital Mulund

Mumbai, India

Location

Fortis hospitals

Mumbai, India

Location

Global Hospital,Parel

Mumbai, India

Location

Global Hospital

Mumbai, India

Location

Holy Family Hospital

Mumbai, India

Location

Nanavati Hospital Icu-1

Mumbai, India

Location

Nanavati hospital ICU-2

Mumbai, India

Location

Nanavati Hospital Icu-3

Mumbai, India

Location

Nanavati Hospital

Mumbai, India

Location

Nanavati hosptial

Mumbai, India

Location

Pd Hinduja National Hospital and Mrc

Mumbai, India

Location

s.l.Rahej hospital- a fortis associate

Mumbai, India

Location

Sir H N Reliance Foundation Hospital

Mumbai, India

Location

Suasth Health Care

Mumbai, India

Location

Tata Memorial Hospital (FICU)

Mumbai, India

Location

Tata Memorial Hospital (SICU)

Mumbai, India

Location

Wockhardt Hopsital South Mumbai

Mumbai, India

Location

Cauvery Heart and multispeciality hospital

Mysore, India

Location

Jss Hospital

Mysore, India

Location

Gopalagowda Shanthaveri Memorial Hospital

Mysuru, India

Location

Aditya Hospital

Nagpur, India

Location

Dew medicare and Trinity Hospital

Nagpur, India

Location

Dr V E Tambe Critical Care

Nagpur, India

Location

Meditrina Institute Of Medical Scineces

Nagpur, India

Location

Orange City Hospital And Research Institute

Nagpur, India

Location

Rahate Surgical Hospital and Iccu

Nagpur, India

Location

Shree Hospital and Critical Care Centre

Nagpur, India

Location

Apollo Hospitals

Nashik, India

Location

National Burns Centre

Navi Mumbai, India

Location

Narayana Medical College Icu-1

Nellore, India

Location

Narayana Medical College

Nellore, India

Location

Simhapuri Hospital

Nellore, India

Location

Batra Hospital & Medical Research Center

New Delhi, India

Location

Batra Hospital

New Delhi, India

Location

BLK hospital

New Delhi, India

Location

Blk Superspeciality Hospital

New Delhi, India

Location

Fortis Escorts Heart Institute

New Delhi, India

Location

Fortis Hospital, Shalimar Bagh

New Delhi, India

Location

GB Pant Institute of Post Graduate Medical Education & Research

New Delhi, India

Location

Indraprastha Apollo Hospitals ICU-1

New Delhi, India

Location

Indraprastha apollo hospitals

New Delhi, India

Location

Max Super Specialty Hospital Patparganj

New Delhi, India

Location

Northern railway central hospital

New Delhi, India

Location

Sri balaji action medical institute ICU-1

New Delhi, India

Location

Sri Balaji Action Medical Institute

New Delhi, India

Location

Venkateshwar Hospital

New Delhi, India

Location

Fortis Hospital

Noida, India

Location

Promhex Multispeciality Hospital

Noida, India

Location

Ojas hospital

Panchkula, India

Location

All India Institute of Medical Sciences Patna

Patna, India

Location

Indira Gandhi Institute of Medical Sciences

Patna, India

Location

Prabhat Kumar

Patna, India

Location

Bharati Vidyapeeth Deemed university and Medical College Hospital

Pune, India

Location

Columbia Asia hospital

Pune, India

Location

Jupiter Hospital

Pune, India

Location

Niramaya Hoapital

Pune, India

Location

Ruby Hall Clinic Icu-1

Pune, India

Location

Ruby Hall Clinic ICU-2

Pune, India

Location

Vishwaraj Hospital & Research Centre

Pune, India

Location

Vishwaraj Hospital& Research Center

Pune, India

Location

Om Hospital

Raipur, India

Location

Pt. J. N. M. Medical College

Raipur, India

Location

Ramskrishna care hospital

Raipur, India

Location

Shree Narayana Hospital

Raipur, India

Location

Genesis Multispeciality Hospital

Rajkot, India

Location

Shree Giriraj Multispeciality hospital

Rajkot, India

Location

Shree Giriraj Multispecialty Hospital

Rajkot, India

Location

Sterling Hospital, Rajkot (A Division of Sterling Addlife India Private Limited)

Rajkot, India

Location

Synergy superspeciality hospital

Rajkot, India

Location

Bhagwan Mahavir Medica Superspecialty Hospital

Ranchi, India

Location

Sagarshree Hospital

Sāgar, India

Location

Abdul Waheed Mir

Srinagar, India

Location

Sheri Kashmir Institute of Medical Sciences

Srinagar, India

Location

Kiran Hospital

Surat, India

Location

Shree Sardar Smarak Hospital

Surat, India

Location

Trichy Srm Medical College Hospital & Research Centre

Tiruchirappalli, India

Location

Believers Church Medical College and Hospital

Tiruvalla, India

Location

Kerala Institute of Medical sciences

Trivandrum, India

Location

Siddaganga hospital and research centre

Tūmulūru, India

Location

Sterling Hospitals

Vadodara, India

Location

Homi Bhaba Cancer Hospital & Pandit Madan Mohan Malviya Cancer Centre,Tata Memorial Centre,Varanasi

Varanasi, India

Location

S S Hospital BHU VARANASI

Varanasi, India

Location

Christian Medical College

Vellore, India

Location

Nagarjuna hospital

Vijayawada, India

Location

St Ann Hospital

Visakhapatnam, India

Location

Samraksha super speciality

Warangal, India

Location

Arnam Hospital

Wardha, India

Location

Related Publications (17)

  • Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.

    PMID: 24171518BACKGROUND
  • Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4.

    PMID: 15090974BACKGROUND
  • Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med. 2004 Apr;30(4):536-55. doi: 10.1007/s00134-004-2210-z. Epub 2004 Mar 3.

    PMID: 14997291BACKGROUND
  • Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.

    PMID: 18158437BACKGROUND
  • Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. doi: 10.1007/s00134-007-0934-2. Epub 2007 Dec 4.

    PMID: 18058085BACKGROUND
  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

    PMID: 23361625BACKGROUND
  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

    PMID: 23353941BACKGROUND
  • Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC; Surviving Sepsis Campaign. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010 Feb;38(2):367-74. doi: 10.1097/CCM.0b013e3181cb0cdc.

    PMID: 20035219BACKGROUND
  • Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.

    PMID: 25275252BACKGROUND
  • Levy MM, Pronovost PJ, Dellinger RP, Townsend S, Resar RK, Clemmer TP, Ramsay G. Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med. 2004 Nov;32(11 Suppl):S595-7. doi: 10.1097/01.ccm.0000147016.53607.c4. No abstract available.

    PMID: 15542969BACKGROUND
  • Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015.

    PMID: 25946168BACKGROUND
  • Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.

    PMID: 26109396BACKGROUND
  • Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

    PMID: 28098591BACKGROUND
  • Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

    PMID: 28101605BACKGROUND
  • Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS, Lemeshow S, Osborn T, Terry KM, Levy MM. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-2244. doi: 10.1056/NEJMoa1703058. Epub 2017 May 21.

    PMID: 28528569BACKGROUND
  • Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, Adams C, Escobar GJ, Whippy A. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med. 2016 Jun 1;193(11):1264-70. doi: 10.1164/rccm.201507-1489OC.

    PMID: 26695114BACKGROUND
  • Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.

    PMID: 29675566BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Sheila N Myatra, MD

    Tata Memorial Hospital, Parel, Mumbai-12

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 29, 2019

Study Start

October 22, 2019

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available

Locations