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Recruiting NCT06500156

Metabolic Cluster Analysis in Septic Shock Patients

— Observational Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluid challenge.
Who it may be relevant to
Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Fluid challenge
    Rapid infusion (\< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc)

Primary outcome measures

  • VO2-response [Time frame: 30 minutes]
Secondary outcome measures (2)
  • Organ failure [Time frame: 4 days]
  • Mortality [Time frame: 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Universitari Parc Taulí — Sabadell

Identifiers

NCT: NCT06500156 · 20235121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗