NCT04608825

Brief Summary

The purpose of this study is to study the prevalence of post cardiac arrest syndrome (PCAS) among ICU patients, to analyze the effectiveness of intensive care, to assess the factors associated with death and the development of severe neurological deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

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

Study Start

First participant enrolled

May 11, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

3.5 years

First QC Date

October 21, 2020

Last Update Submit

January 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of PCAS in the ICU

    post cardiac arrest syndrome in patients of intensive care unit

    during each patient hospitalization, an average of 1 month

Eligibility Criteria

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

Patients in ICU

You may qualify if:

  • patients with out-of-hospital and in-hospital successful CPR; ·
  • age - from 18 years old; ·
  • survival after CPR - more than 24 hours.

You may not qualify if:

  • age less than 18 years; ·
  • death occurring less than 24 hours after CPR; ·
  • oncological pathology in the terminal stage; ·
  • severe neurological deficits and cognitive dysfunction that occurred before CPR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CEO Irkutsk State Medical Academy of Postgraduate Education - Branch Campus of the FSBEI FPE RMACPE MOH Russia

Irkutsk, Russia

Location

City Clinical Hospital No.3

Irkutsk, Russia

Location

Irkutsk City Clinical Hospital No.1

Irkutsk, Russia

Location

Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky

Kemerovo, Russia

Location

Krasnoyarsk interdistrict clinical hospital of emergency medical care named after NS Karpovich

Krasnoyarsk, Russia

Location

Krasnoyarsk interdistrict clinical hospital №20 named after I.S. Berzona Krasnoyarsk, Russia

Krasnoyarsk, Russia

Location

Krasnoyarsk interdistrict clinical hospital №4 Krasnoyarsk, Russia

Krasnoyarsk, Russia

Location

Regional clinical hospital

Krasnoyarsk, Russia

Location

Federal research and clinical center of intensive care medicine and rehabilitology

Moscow, Russia

Location

Orenburg City N.I. Pirogov Clinical Hospital

Orenburg, Russia

Location

Orenburg regional clinical hospital

Orenburg, Russia

Location

Related Publications (18)

  • Andersen LW, Holmberg MJ, Berg KM, Donnino MW, Granfeldt A. In-Hospital Cardiac Arrest: A Review. JAMA. 2019 Mar 26;321(12):1200-1210. doi: 10.1001/jama.2019.1696.

    PMID: 30912843BACKGROUND
  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND
  • Chan PS, McNally B, Tang F, Kellermann A; CARES Surveillance Group. Recent trends in survival from out-of-hospital cardiac arrest in the United States. Circulation. 2014 Nov 18;130(21):1876-82. doi: 10.1161/CIRCULATIONAHA.114.009711.

    PMID: 25399396BACKGROUND
  • Chan PS, Nallamothu BK, Krumholz HM, Spertus JA, Li Y, Hammill BG, Curtis LH; American Heart Association Get with the Guidelines-Resuscitation Investigators. Long-term outcomes in elderly survivors of in-hospital cardiac arrest. N Engl J Med. 2013 Mar 14;368(11):1019-26. doi: 10.1056/NEJMoa1200657.

    PMID: 23484828BACKGROUND
  • 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
  • Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.

    PMID: 26092673BACKGROUND
  • Dragancea I, Rundgren M, Englund E, Friberg H, Cronberg T. The influence of induced hypothermia and delayed prognostication on the mode of death after cardiac arrest. Resuscitation. 2013 Mar;84(3):337-42. doi: 10.1016/j.resuscitation.2012.09.015. Epub 2012 Sep 20.

    PMID: 23000363BACKGROUND
  • Elmer J, Scutella M, Pullalarevu R, Wang B, Vaghasia N, Trzeciak S, Rosario-Rivera BL, Guyette FX, Rittenberger JC, Dezfulian C; Pittsburgh Post-Cardiac Arrest Service (PCAS). The association between hyperoxia and patient outcomes after cardiac arrest: analysis of a high-resolution database. Intensive Care Med. 2015 Jan;41(1):49-57. doi: 10.1007/s00134-014-3555-6. Epub 2014 Dec 4.

    PMID: 25472570BACKGROUND
  • Grasner JT, Meybohm P, Lefering R, Wnent J, Bahr J, Messelken M, Jantzen T, Franz R, Scholz J, Schleppers A, Bottiger BW, Bein B, Fischer M; German Resuscitation Registry Study Group. ROSC after cardiac arrest--the RACA score to predict outcome after out-of-hospital cardiac arrest. Eur Heart J. 2011 Jul;32(13):1649-56. doi: 10.1093/eurheartj/ehr107. Epub 2011 Apr 22.

    PMID: 21515626BACKGROUND
  • Jakkula P, Reinikainen M, Hastbacka J, Loisa P, Tiainen M, Pettila V, Toppila J, Lahde M, Backlund M, Okkonen M, Bendel S, Birkelund T, Pulkkinen A, Heinonen J, Tikka T, Skrifvars MB; COMACARE study group. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Med. 2018 Dec;44(12):2112-2121. doi: 10.1007/s00134-018-5453-9. Epub 2018 Nov 14.

    PMID: 30430209BACKGROUND
  • Zylke JW. Drug war intelligence gathering: risky, but useful to physicians. JAMA. 1988 Oct 21;260(15):2169-70. No abstract available.

    PMID: 3172392BACKGROUND
  • Capani F, Della Loggia F, Sensi S. [Pancreatic diabetes. Diagnosis and therapy]. Minerva Med. 1976 Jan 28;67(4):301-6. No abstract available. Italian.

    PMID: 1250522BACKGROUND
  • Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

    PMID: 23942856BACKGROUND
  • Ritter MM, Sonnichsen AC, Mohrle W, Richter WO, Schwandt P. Beta-endorphin plasma levels and their dependence on gender during an enteral glucose load in lean subjects as well as in obese patients before and after weight reduction. Int J Obes. 1991 Jun;15(6):421-7.

    PMID: 1885266BACKGROUND
  • Merchant RM, Yang L, Becker LB, Berg RA, Nadkarni V, Nichol G, Carr BG, Mitra N, Bradley SM, Abella BS, Groeneveld PW; American Heart Association Get With The Guidelines-Resuscitation Investigators. Incidence of treated cardiac arrest in hospitalized patients in the United States. Crit Care Med. 2011 Nov;39(11):2401-6. doi: 10.1097/CCM.0b013e3182257459.

    PMID: 21705896BACKGROUND
  • Mulder M, Gibbs HG, Smith SW, Dhaliwal R, Scott NL, Sprenkle MD, Geocadin RG. Awakening and withdrawal of life-sustaining treatment in cardiac arrest survivors treated with therapeutic hypothermia*. Crit Care Med. 2014 Dec;42(12):2493-9. doi: 10.1097/CCM.0000000000000540.

    PMID: 25121961BACKGROUND
  • Nolan JP, Berg RA, Callaway CW, Morrison LJ, Nadkarni V, Perkins GD, Sandroni C, Skrifvars MB, Soar J, Sunde K, Cariou A. The present and future of cardiac arrest care: international experts reach out to caregivers and healthcare authorities. Intensive Care Med. 2018 Jun;44(6):823-832. doi: 10.1007/s00134-018-5230-9. Epub 2018 Jun 2.

    PMID: 29860705BACKGROUND
  • Perman SM, Stanton E, Soar J, Berg RA, Donnino MW, Mikkelsen ME, Edelson DP, Churpek MM, Yang L, Merchant RM; American Heart Association's Get With the Guidelines(R)-Resuscitation (formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Location of In-Hospital Cardiac Arrest in the United States-Variability in Event Rate and Outcomes. J Am Heart Assoc. 2016 Sep 29;5(10):e003638. doi: 10.1161/JAHA.116.003638.

    PMID: 27688235BACKGROUND

MeSH Terms

Conditions

Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesCardiovascular DiseasesReperfusion InjuryVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir Gorbachev, MD

    CEO Irkutsk State Medical Academy of Postgraduate Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 29, 2020

Study Start

May 11, 2020

Primary Completion

November 11, 2023

Study Completion

December 11, 2023

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations