Volume Kinetics of Fluid Resuscitation in Early Sepsis

NCT06499701 | Recruiting DMC FDA Drug

• 1 other identifier: 17736
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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 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

Fluid and Electrolyte Imbalance

Keywords

volume kinetics; sepsis; volume resuscitation; crystalloid; Ringer's Lactate

Outcome Measures

Primary Outcomes (1)

• Plasma Volume

  Plasma volume (ml) was determined using a three-compartment kinetic model with five rate constants (k12, k21, k23, k32 and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.

  180 minutes after the start of the Ringer's Lactate infusion

Study Arms (1)

Ringer's Lactate

Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation (i.e., 30 ml/kg crystalloid).

Drug: Ringer's Lactate

Interventions

Ringer's Lactate DRUG

Ringer's Lactate is administered at a dose of 30ml/kg, with the first 20ml/kg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml/kg over the next 15 minutes, completing the infusion within 75 minutes.

Also known as: Crystalloid

Ringer's Lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (2)

Fundeni Clinical Institute

Bucharest, București, 022328, Romania

RECRUITING

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Ringer's Lactate; Crystalloid Solutions

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robert Hahn, Professor

  Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment

  STUDY CHAIR

• Serban-Ion Bubenek-Turconi, Professor

  "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

  STUDY DIRECTOR

Central Study Contacts

Cosmin Balan, PhD

CONTACT

0722751501; cosmin13mara@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

RO (2)