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

Not Applicable

Not yet recruiting

• Conditions: Septic Shock

• Registration Number: NCT06568744
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosed or suspected septic shock<br><br> - < 24 hours since diagnosis<br><br> - Hypoperfusion signal (altered arterial lactate or CRT) that requires further<br> resuscitation<br><br> - Mechanical ventilation<br><br> - Positive fluid responsiveness status<br><br>Exclusion Criteria:<br><br> - Pregnancy<br><br> - Do-not-resuscitate status<br><br> - Acute coronary syndrome<br><br> - Active bleeding<br><br> - Severe concomitant acute respiratory distress syndrome (ARDS) (PaO2:FiO2 ratio <<br> 100)<br><br> - Anticipated surgery, prone positioning, or renal replacement therapy in the next 6<br> hours<br><br> - Refractory shock according to attending physician<br><br> - BMI > 40.<br><br> - Inadequate echocardiographic window

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta of PaO2: fraction of inspired oxygen (FiO2) ratio between 0-6 hours

Secondary Outcome Measures

Name	Time	Method
Delta of proBNP between 0-6 hours;Delta of plasma neutrophil gelatinase-associated lipocalin (NGAL) between 0-6 hours;Delta of creatinine between 0-6 hours;Delta of capillary refill time between 0-6 hours;Delta of arterial lactate between 0-6 hours