Actively Recruiting
Volume Kinetics of Fluid Resuscitation in Early Sepsis
Led by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu · Updated on 2026-03-18
15
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.
CONDITIONS
Official Title
Volume Kinetics of Fluid Resuscitation in Early Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sepsis by Sepsis-3 criteria with sepsis-induced hypoperfusion before volume resuscitation
- Hypotension requiring norepinephrine to keep mean arterial pressure at or above 65 mm Hg or as decided by the clinician
- Or serum lactate level greater than 2 mmol/L (18 mg/dL)
- Or acute oliguria with urine output less than 0.5 mL/kg/hour
- Or mottled skin
- Or capillary refill time longer than 3 seconds
You will not qualify if you...
- Received at least 1 liter of intravenous fluid in the 6 hours before screening, including crystalloids, colloids, or blood products
- Known pregnancy
- Other causes of lactic acidosis such as recent seizures, certain medications (linezolid, metformin, anti-retrovirals), poisoning, ischemic bowel, or mitochondrial disorders
- End-stage kidney disease requiring chronic dialysis
- Concurrent hemorrhagic or obstructive shock
- Increased risk of fluid intolerance demonstrated by moderate or severe left or right ventricular systolic dysfunction on echocardiography
- Hypoxemia index less than 200 mmHg or sonographic evidence of bilateral B or C lung profiles
- Abdominal compartment syndrome
- Post-cardiac arrest status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Fundeni Clinical Institute
Bucharest, Bucharest, Romania, 022328
Actively Recruiting
2
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, Romania, 022328
Actively Recruiting
Research Team
C
Cosmin Balan, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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