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Completed

NCT Number: NCT06474052

Volume Kinetics of Gelofusine 4% During 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.

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Key information

Conditions

Fluid Electrolyte Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu

Bucharest, 022328, Romania

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gelofusine 4%

Drug

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

Other names: Colloid

Primary outcomes

  1. Plasma Volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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