Severe Septic Shock Complications

Identifying Risk Factors for Complications in Severe Septic Shock

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

Study Overview

• Status: Unknown
• Conditions: Septic Shock

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17007
    • Hospital Universitari Dr Josep Trueta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Rejecting participation by not signing informed consent form.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate clearance	Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy	Number of days from the last day free of vasopressors, mechanical ventilation and Renal Replacement Therapy up to day 28. If patients dies it scores 0.	28 days
Mechanical Ventilation-free days	Days free of mechanical ventilation up to day 28	28 days
Vasopressors-free days	Days free of vasopressors up to day 28	28 days
Rate of Acute Kidney Injury	Kidney Disease: Improving Global Outcomes definition	28 days
ICU length of stay	Days in ICU	28 days
Hospital length of stay	Days in Hospital	30 days
Rate of In-hospital Mortality	Any cause mortality	30 days
Rate of Acute Respiratory Distress Syndrome	Berlin definition	28 days
Rate of New Atrial Fibrilation	New atrial fibrilation requiring treatment	28 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 21, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Lactate clearance; Severe Septic Shock; Days alive and free; Ventilation-free days; Vasopressor-free days
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: SSS-500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No