Understanding fluid resuscitation in early sepsis

Volume Kinetics of Fluid Resuscitation With 30 ml/kg Ringer Lactate in Early Sepsis

This study looks at how giving a specific amount of fluid to adults with early sepsis helps their bodies respond and recover in the ICU.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu (Academic / other)
• Locations: 2 sites (Bucharest, Bucharest and 1 other locations)
• Trial ID: NCT06499701 on ClinicalTrials.gov

What this trial studies

This observational study investigates the volume kinetics of administering 30 ml/kg of Ringer's Lactate in adult patients with early sepsis-induced hypoperfusion. Patients admitted to the ICU who meet the Sepsis-3 criteria will receive the fluid resuscitation within the first three hours of their treatment. The study aims to analyze how this volume affects fluid shifts between plasma and interstitial compartments, while also monitoring various physiological parameters. Data collected will include blood gas analysis, urinary output, and hemodilution metrics to better understand individual patient responses to fluid resuscitation.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with sepsis and exhibiting signs of hypoperfusion who have not received significant prior fluid resuscitation.

Not a fit: Patients who have received at least 1 L of IV fluid in the last 6 hours or have conditions that complicate lactic acidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized fluid resuscitation strategies for patients with sepsis, potentially improving outcomes.

How similar studies have performed: While the approach of studying volume kinetics in sepsis is not widely tested, similar studies have shown the importance of personalized fluid management in critical care settings.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

* 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.

Where this trial is running

Bucharest, Bucharest and 1 other locations

• Fundeni Clinical Institute — Bucharest, Bucharest, Romania (Recruiting)
• "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases — Bucharest, Romania (Recruiting)

Study contacts

• Study coordinator: Cosmin Balan, PhD

Conditions Fluid and Electrolyte Imbalance; volume kinetics; sepsis; volume resuscitation; crystalloid; Ringer's Lactate