Metabolic Cluster Analysis in Septic Shock Patients
ACMEcat
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
December 5, 2025
November 1, 2025
2.5 years
July 8, 2024
November 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VO2-response
Percentage increase in VO2 as results of the fluid challenge
30 minutes
Secondary Outcomes (2)
Organ failure
4 days
Mortality
28 days
Study Arms (1)
Septic shock
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.
Interventions
Rapid infusion (\< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc)
Eligibility 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.
You may qualify if:
- \- 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%).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 8, 2024
First Posted
July 15, 2024
Study Start
May 1, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 5, 2025
Record last verified: 2025-11