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

NARecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

August 22, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2026

Conditions
Septic Shock
Interventions
OTHER

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."

OTHER

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.

Trial Locations (3)

Unknown

RECRUITING

Hospital Biprovincial Quillota-Petorca, Quillota

RECRUITING

Hospital Barros Luco, Santiago

RECRUITING

Hospital Clinico UC Christus, Santiago

All Listed Sponsors
lead

Pontificia Universidad Catolica de Chile

OTHER