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Volume Kinetics of Gelofusine 4% During Vascular Surgery

Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06474052
Enrollment
15
Registered
2024-06-25
Start date
2024-01-01
Completion date
2024-04-15
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Electrolyte Disorders

Keywords

colloid, volume kinetics, Gelofusine 4%

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%.

Interventions

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

Sponsors

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma Volume180 minutes after the start of the Gelofusine 4% infusionPlasma 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.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026