Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard of care, for a 6 hour study protocol. The main question it aims to answer is 1. To compare the effect of both resuscitation strategies on fluid-induced harm, assessed by the change in pulmonary, cardiac, and renal function biomarkers during the study period. 2. To assess the safety of both resuscitation strategies on hypoperfusion resolution, measured by the improvement of capillary refill time (CRT) and lactate during the study period. 3. To determine the dynamics of the different fluid intolerance signals

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Diagnosed or suspected septic shock

• \< 24 hours since diagnosis

• Hypoperfusion signal (altered arterial lactate or CRT) that requires further resuscitation

• Mechanical ventilation

• Positive fluid responsiveness status

Locations
Other Locations
Chile
Hospital Biprovincial Quillota-Petorca
RECRUITING
Quillota
Hospital Barros Luco
RECRUITING
Santiago
Hospital Clinico UC Christus
RECRUITING
Santiago
Contact Information
Primary
Eduardo Kattan, MD, PhD
e.kattan@gmail.com
+56223543292
Backup
Ricardo Castro, MD
rcastro.med@gmail.com
+56223543292
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2026-07
Participants
Target number of participants: 62
Treatments
Experimental: Intervention
This group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, fluid intolerance signals, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations.
Active_comparator: Standard of Care
This group will follow a resuscitation algorithm aimed at macrohemodynamic stabilization and improvement of tissue hypoperfusion. Fluid administration will be tailored according to fluid responsiveness status, and hypoperfusion signals such as capillary refill time. Mechanical ventilation and sedation will follow standard management as per current recommendations.
Related Therapeutic Areas
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov