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Volume Kinetics of Fluid Resuscitation in Early Sepsis

Recruiting
Conditions
Fluid and Electrolyte Imbalance
Registration Number
NCT06499701
Lead Sponsor
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
15
Inclusion Criteria

Inclusion Criteria:<br><br>A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced<br>hypoperfusion prior to the administration of adequate volume resuscitation:<br><br> - hypotension requiring norepinephrine to maintain a mean arterial blood pressure<br> (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or<br><br> - a serum lactate level >2 mmol/L (18mg/dL) and/or<br><br> - acute oliguria defined as urine output <0.5mL/kg/hr and/or<br><br> - mottled skin and/or<br><br> - capillary refill time > 3 seconds.<br><br>Exclusion Criteria:<br><br> - Administration of at least 1 L of IV fluid in the last 6 hours prior to screening.<br> All crystalloids, colloids and blood products that the patient has received are<br> counted.<br><br> - Known pregnancy.<br><br> - Competing causes of lactic acidosis including: seizures within 3 hours of<br> enrollment, use of linezolid or metformin or anti-retrovirals at the time of<br> enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic<br> bowel, and known mitochondrial disorders.<br><br> - End-stage renal disease that requires chronic dialysis.<br><br> - Concurrent haemorrhagic or obstructive shock.<br><br> - Increased risk of fluid intolerance:<br><br> - Echocardiographic evidence of moderate or severe left ventricular systolic<br> dysfunction.<br><br> - Echocardiographic evidence of moderate or severe right ventricular systolic<br> dysfunction.<br><br> - Hypoxemia index < 200 mmHg or sonographic evidence of bilateral B or C profile.<br><br> - Abdominal compartment syndrome.<br><br> - Post-cardiac arrest.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma Volume
Secondary Outcome Measures
NameTimeMethod
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