Clinical trial NCT03716895: Severe Septic Shock Complications
Official title: Identifying Risk Factors for Complications in Severe Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: Severe Septic Shock
Lactate clearance
Acute Kidney Injury
Days alive and free
Ventilation-free days
Vasopressor-free days
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lactate clearance
timeFrame: 30 days
Secondary outcomes:
measure: Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy
timeFrame: 28 days
measure: Mechanical Ventilation-free days
timeFrame: 28 days
measure: Vasopressors-free days
timeFrame: 28 days
measure: Rate of Acute Kidney Injury
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Rate of In-hospital Mortality
timeFrame: 30 days
measure: Rate of Acute Respiratory Distress Syndrome
timeFrame: 28 days
measure: Rate of New Atrial Fibrilation
timeFrame: 28 days
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr Josep Trueta
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.