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Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Sponsor: Pontificia Universidad Catolica de Chile
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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2024-08-22
Completion Date
2026-07
Last Updated
2024-10-02
Healthy Volunteers
No
Conditions
Interventions
Intervention resuscitation
In fluid responsive patients, fluid intolerance will be checked. Lung Ultrasound (LUS): Anterior LUS with 4-point assessment at each hemithorax. Min:0 and a max:24. Low risk: \< 10; intermediate risk: 10-14 or delta of 2 points. High risk: \>14, or an increase \>4 from baseline. VExUS: Low risk: Grade 0-1. Intermediate risk: 2. High risk: 3 E/e' ratio: Low risk: \<8. Intermediate risk: 8-13. High risk \>14. Central venous pressure (CVP): Low risk \<12 mmHg. Intermediate risk: 12-15 mmHg or a delta of 3 mmHg. High risk \> 15 mmHg or \>5 mmHg increase after a fluid challenge. In low-risk, a fluid challenge of 500 ml of balanced crystalloid will be performed in 30 minutes. If intermediate risk, a fluid challenge of 250 ml of balanced crystalloid in 30 minutes. If high-risk signals, alternative strategies (vasopressor and inodilator tests) will be deployed. After each challenge, peripheral perfusion, fluid responsiveness and intolerance will be re-assessed.
Standard of Care resuscitation
In fluid responsive patients, fluid challenges of 500 ml of balanced crystalloid will be performed in 30 minutes. After a fluid challenge, peripheral perfusion status and fluid responsiveness will be re-measured. If the patient persists with hypoperfusion, successive fluid challenges will be performed until hypoperfusion resolves or the patient becomes fluid unresponsive. If hypoperfusion signals persists and the patient becomes fluid unresponsive, alternative resuscitation interventions will be deployed, which include: 1) vasopressor titration to higher mean arterial pressure (MAP) targets in a MAP-test, and 2) addition of an inotrope to increase cardiac output in an inodilator test. If hypoperfusion fails to resolve, rescue therapies such as high-volume hemofiltration will be initiated.
Locations (3)
Hospital Biprovincial Quillota-Petorca
Quillota, Chile
Hospital Barros Luco
Santiago, Chile
Hospital Clinico UC Christus
Santiago, Chile