Metabolic Cluster Analysis in Septic Shock Patients

Recruiting

• Conditions: Septic Shock

• Registration Number: NCT06500156
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 < 70%).

Exclusion Criteria

• Age under 18 years old
• Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.
• Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VO2-response	30 minutes	Percentage increase in VO2 as results of the fluid challenge

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days	Mortality within the first 28 days
Organ failure	4 days	Assessment of the SOFA score at day 1, 2 and 4

Trial Locations

Locations (1)

Hospital Universitari Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain