Volume Kinetics of Gelofusine 4% During Vascular Surgery

Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Fluid Electrolyte Disorders
• Intervention / Treatment: Drug: Gelofusine 4%

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Romania
  • București
    • Bucuresti, București, Romania, 022328
      • Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 80 years undergoing uncomplicated vascular surgery under general anesthesia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gelofusine 4%; Adult patients undergoing uncomplicated vascular surgery.	Drug: Gelofusine 4%; Gelofusine 4% 10 ml/kg is administered following anaesthesia induction in 30 minutes.; Other Names: Colloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 minutes after the start of the Gelofusine 4% infusion

Collaborators and Investigators

• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
• Investigators: Study Director: Robert Hahn, Professor, Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: colloid; volume kinetics; Gelofusine 4%
• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Polygeline
• Other Study ID Numbers: 1391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No