Severe Septic Shock Complications

Septic Shock Clinical Trial

Official title:

Identifying Risk Factors for Complications in Severe Septic Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716895
• Other study ID #: SSS-500
• Status: Not yet recruiting
• Start date: December 2018
• Est. completion date: March 2020

Study information

• Verified date: October 2018
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Marc Vives, PhD, DESA
• Phone: +34972940200
• Email: marcvives50[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé 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. — View Citation

Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyère R, Lebert C, Bohé 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. — View Citation

McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Côté 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. Review. — View Citation

Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Tolédano 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate clearance	Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L	30 days
Secondary	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
Secondary	Mechanical Ventilation-free days	Days free of mechanical ventilation up to day 28	28 days
Secondary	Vasopressors-free days	Days free of vasopressors up to day 28	28 days
Secondary	Rate of Acute Kidney Injury	Kidney Disease: Improving Global Outcomes definition	28 days
Secondary	ICU length of stay	Days in ICU	28 days
Secondary	Hospital length of stay	Days in Hospital	30 days
Secondary	Rate of In-hospital Mortality	Any cause mortality	30 days
Secondary	Rate of Acute Respiratory Distress Syndrome	Berlin definition	28 days
Secondary	Rate of New Atrial Fibrilation	New atrial fibrilation requiring treatment	28 days