Actively Recruiting
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Led by Pontificia Universidad Catolica de Chile · Updated on 2024-10-02
62
Participants Needed
3
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed or suspected septic shock
- Less than 24 hours since diagnosis
- Signs of low blood flow needing further fluids (altered arterial lactate or capillary refill time)
- Receiving mechanical ventilation
- Positive fluid responsiveness status
You will not qualify if you...
- Pregnancy
- Do-not-resuscitate status
- Acute coronary syndrome
- Active bleeding
- Severe acute respiratory distress syndrome with PaO2:FiO2 ratio below 100
- Planned surgery, prone positioning, or kidney dialysis in next 6 hours
- Refractory shock as judged by doctor
- Body mass index over 40
- Poor echocardiographic window
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hospital Biprovincial Quillota-Petorca
Quillota, Chile
Actively Recruiting
2
Hospital Barros Luco
Santiago, Chile
Actively Recruiting
3
Hospital Clinico UC Christus
Santiago, Chile
Actively Recruiting
Research Team
E
Eduardo Kattan, MD, PhD
CONTACT
R
Ricardo Castro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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