Metabolic Cluster Analysis in Septic Shock Patients (ACMEcat)

November 28, 2025 updated by: Jaume Mesquida, Corporacion Parc Tauli

Metabolic Cluster Analysis in Septic Shock Patients Undergoing Hemodynamic Resuscitation. A Multicenter Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Sub-Investigator:
          • Edgar Cortés, MD
        • Sub-Investigator:
          • Guillem Gruartmoner, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ferran Oller, MD
        • Principal Investigator:
          • Jaume Mesquida, MD
        • Sub-Investigator:
          • Sara Nogales, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Fluid challenge
Rapid infusion (< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2-response
Time Frame: 30 minutes
Percentage increase in VO2 as results of the fluid challenge
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ failure
Time Frame: 4 days
Assessment of the SOFA score at day 1, 2 and 4
4 days
Mortality
Time Frame: 28 days
Mortality within the first 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20235121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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