Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568744
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Fluids are the first-line hemodynamic therapy during septic shock resuscitation restoring tissue perfusion by effectively increasing cardiac output and oxygen delivery Nevertheless resuscitation fluids can be seen as a double-edged sword since they have a narrow therapeutic index In the one hand insufficient fluid administration can perpetuate hypoperfusion leading to irreversible tissue hypoxia while excessive fluid administration can lead to fluid-induced harm The extreme scenario of this condition fluid overload has been consistently associated with worse clinical outcomes including increased risks of prolonged mechanical ventilation acute kidney injury and mortality As an eminently retrospective diagnosis it may underestimate the importance of timely recognition of fluid-induced harm during the resuscitation period and could shift clinicians efforts to treatment rather than prevention Thus identifying organ-specific venous congestion signals early on during the resuscitation process is desirable and could avoid these adverse outcomes Recent studies have shown that venous congestion signals are present even during the first day of ICU admission
The investigators hypothesized that in critically ill patients with septic shock a fluid resuscitation strategy that integrates fluid intolerance signals as safety limits will prevent fluid-induced harm without compromising hypoperfusion resolution compared to a standard resuscitation strategy
To confirm this hypothesis the investigators propose a multicenter prospective randomized controlled study in 62 critically ill patients with septic shock comparing two strategies for conducting fluid resuscitation aiming to decrease fluid-induced harm One strategy will follow the standard of care while the other will rest on real-time ultrasound-based monitoring of fluid intolerance signals The latter approach will allow clinicians to limit fluid administration when potentially deleterious signals appear The impact of both strategies on fluid-induced harm will be assessed by the evolution of key organ function biomarkers namely lungs heart and kidneys during the 6-hour study period Perfusion dynamics will be assessed by capillary refill time and arterial lactate kinetics during the study period Patients will receive general monitoring and management according to ICU standards Patients will be followed-up for 28 days for other relevant outcomes
The investigators hypothesized that in critically ill patients with septic shock a fluid resuscitation strategy that integrates fluid intolerance signals as safety limits will prevent fluid-induced harm without compromising hypoperfusion resolution compared to a standard resuscitation strategy
To confirm this hypothesis the investigators propose a multicenter prospective randomized controlled study in 62 critically ill patients with septic shock comparing two strategies for conducting fluid resuscitation aiming to decrease fluid-induced harm One strategy will follow the standard of care while the other will rest on real-time ultrasound-based monitoring of fluid intolerance signals The latter approach will allow clinicians to limit fluid administration when potentially deleterious signals appear The impact of both strategies on fluid-induced harm will be assessed by the evolution of key organ function biomarkers namely lungs heart and kidneys during the 6-hour study period Perfusion dynamics will be assessed by capillary refill time and arterial lactate kinetics during the study period Patients will receive general monitoring and management according to ICU standards Patients will be followed-up for 28 days for other relevant outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None