Volume Kinetics of Gelofusine 4% During Vascular Surgery

Completed

• Conditions: Fluid Electrolyte Disorders
• Interventions: Drug: Gelofusine 4%

• Registration Number: NCT06474052
• Lead Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Brief Summary

The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Following the induction of anesthesia, Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period. Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile.

Detailed Description

Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period to adult patients undergoing uncomplicated vascular surgery. Arterial blood samples were taken to measure blood hemoglobin concentration and hematocrit at baseline and at 5-minute intervals up to 60 minutes after the infusion began, followed by 10-minute intervals up to 90 minutes, and then at 30-minute intervals up to 180 minutes. Urine output and total intraoperative blood loss were continuously monitored. The plasma hemodilution data were fitted to a bicompartmental model to derive the intercompartmental kinetics of Gelofusine 4%.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-15
• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Informed consent.
• Elective open vascular surgery with a minimal risk of perioperative complications.
• Hemodynamic stability before induction (no chest pain, SBP > 100 mmHg, MAP ≥ 60 mmHg, 50 < HR < 100 bpm).

Exclusion Criteria

• Known allergy to 4% Gelofusine.
• Patient refusal to participate in the study.
• Non-elective/emergency surgical interventions.
• The American Society of Anesthesiologists (ASA) > 3.
• Any preoperative hemodynamic support (mechanical or pharmacological).
• Moderate or severe left ventricular dysfunction (LVEF ≤ 44%).
• Moderate or severe right ventricular dysfunction.
• Diastolic dysfunction of any degree.
• Baseline hypoxemia index < 300 mmHg.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gelofusine 4%	Gelofusine 4%	Adult patients undergoing uncomplicated vascular surgery.

Primary Outcome Measures

Name	Time	Method
Plasma Volume	180 minutes after the start of the Gelofusine 4% infusion	Plasma volume was determined using a two-compartment kinetic model with three rate constants (k12, k21, 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.

Trial Locations

Locations (1)

Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu; 🇷🇴 Bucuresti, București, Romania