Volume Kinetics of Gelofusine 4% During Vascular Surgery

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu15 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Fluid Electrolyte Disorders

Interventions

Gelofusine 4%DRUG

Gelofusine 4% 10 ml/kg is administered following anaesthesia induction in 30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu

Bucharest, Bucharest, Romania

Outcomes

Primary Outcomes

Plasma Volume

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.

Time frame: 180 minutes after the start of the Gelofusine 4% infusion

Data from ClinicalTrials.gov

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