Status:
RECRUITING
Volume Kinetics of Fluid Resuscitation in Early Sepsis
Lead Sponsor:
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Conditions:
Fluid and Electrolyte Imbalance
Eligibility:
All Genders
18+ years
Brief Summary
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized appr...
Detailed Description
Adult patients admitted to the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria, and exhibiting sepsis-induced hypoperfusion prior to receiving adequate volume resuscitation ...
Eligibility Criteria
Inclusion
- A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation:
- hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or
- a serum lactate level \>2 mmol/L (18mg/dL) and/or
- acute oliguria defined as urine output \<0.5mL/kg/hr and/or
- mottled skin and/or
- capillary refill time \> 3 seconds.
Exclusion
- Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.
- Known pregnancy.
- Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.
- End-stage renal disease that requires chronic dialysis.
- Concurrent haemorrhagic or obstructive shock.
- Increased risk of fluid intolerance:
- Echocardiographic evidence of moderate or severe left ventricular systolic dysfunction.
- Echocardiographic evidence of moderate or severe right ventricular systolic dysfunction.
- Hypoxemia index \< 200 mmHg or sonographic evidence of bilateral B or C profile.
- Abdominal compartment syndrome.
- Post-cardiac arrest.
Key Trial Info
Start Date :
June 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06499701
Start Date
June 19 2024
End Date
July 30 2025
Last Update
March 10 2025
Active Locations (2)
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1
Fundeni Clinical Institute
Bucharest, București, Romania, 022328
2
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, Romania, 022328