Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
NCT Number: NCT06568744
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Septic Shock
Interventions: OTHER: Intervention resuscitation|OTHER: Standard of Care resuscitation
Sponsor: Pontificia Universidad Catolica de Chile
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-07
Locations: Hospital Biprovincial Quillota-Petorca, Quillota, Chile|Hospital Barros Luco, Santiago, Chile|Hospital Clinico UC Christus, Santiago, 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

Primary Outcome Measures: Delta of PaO2: fraction of inspired oxygen (FiO2) ratio between 0-6 hours, evolution of lung function during the study period (6h), 6 hours
Secondary Outcome Measures: Delta of proBNP between 0-6 hours, evolution of cardiac function during the study period (6h), 6 hours|Delta of plasma neutrophil gelatinase-associated lipocalin (NGAL) between 0-6 hours, evolution of renal function during the study period (6h), 6 hours|Delta of creatinine between 0-6 hours, evolution of renal function during the study period (6h), 6 hours|Delta of capillary refill time between 0-6 hours, evolution of peripheral perfusion during the study period (6h), 6 hours|Delta of arterial lactate between 0-6 hours, evolution of lactate during the study period (6h), 6 hours
Other Outcome Measures: Delta of PaO2:FiO2 ratio between 24 hours, lung function at the first day since recruitment, 24 hours|Delta of plasma NGAL between 0-24 hours, evolution of kidney function during the first day since recruitment, 24 hours|Delta of creatinine between 0-24 hours, evolution of kidney function during the first day since recruitment, 24 hours|Delta of proBNP between 0-24 hours, evolution of cardiac function during the first day since recruitment, 24 hours|Delta of arterial lactate between 0-24 hours, evolution of lactate during the first day since recruitment, 24 hours|Delta of capillary refill time between 0-24h, evolution of peripheral perfusion during the first day since recruitment, 24 hours|Fluid balance at 24 hours, fluids administered during the first day of protocol, 24 hours|Mortality, mortality rate during the first 28 days, 28 days|ICU length of stay, length of stay in the intensive care unit, 28 days|Organ dysfunction free days, days alive without vasopressor, renal replacement or mechanical ventilation support, 28 days