Severe Septic Shock Complications

NCT03716895 | Unknown

• 1 other identifier: SSS-500
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019. The primary goal is to look for risk factors associated with an increased in lactate clearance Secondary goals are the following:

1. 1.To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
2. 2.To look for risk factors associated with an increase risk of Acute Kidney Injury.
3. 3.To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
4. 4.To look for risk factors associated with a decrease in Ventilator-free days.
5. 5.To look for risk factors associated with a decrease in Vasopressor-free days.
6. 6.To look for risk factors associated with an increase risk of in-hospital mortality.
7. 7.To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
8. 8.To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
9. 9.To compare and validate different risk scores in our cohort.

Conditions

Septic Shock

Keywords

Severe Septic Shock; Lactate clearance; Acute Kidney Injury; Days alive and free; Ventilation-free days; Vasopressor-free days

Outcome Measures

Primary Outcomes (1)

• Lactate clearance

  Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L

  30 days

Secondary Outcomes (9)

• Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy

  28 days

• Mechanical Ventilation-free days

  28 days

• Vasopressors-free days

  28 days

• Rate of Acute Kidney Injury

  28 days

• ICU length of stay

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min

You may qualify if:

• Adults older than 18 years old admitted to ICU with Severe Septic Shock

You may not qualify if:

• Rejecting participation by not signing informed consent form.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Universitari Dr Josep Trueta

Girona, 17007, Spain

Location

Related Publications (4)

• Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Toledano D, Garrouste-Orgeas M, Adrie C, Timsit JF, Azoulay E. Acute Kidney Injury in Severe Sepsis and Septic Shock in Patients with and without Diabetes Mellitus: A Multicenter Study. PLoS One. 2015 May 28;10(5):e0127411. doi: 10.1371/journal.pone.0127411. eCollection 2015.

  PMID: 26020231 BACKGROUND

• Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.

  PMID: 30304656 BACKGROUND

• Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

  PMID: 29490185 BACKGROUND

• McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Cote EP. Association of Vasopressin Plus Catecholamine Vasopressors vs Catecholamines Alone With Atrial Fibrillation in Patients With Distributive Shock: A Systematic Review and Meta-analysis. JAMA. 2018 May 8;319(18):1889-1900. doi: 10.1001/jama.2018.4528.

  PMID: 29801010 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Marc Vives, PhD, DESA

CONTACT

+34972940200; marcvives50@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Lead. Department of Anesthesiology & Critical Care

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 23, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

ES (1)