Volume Kinetics of Gelofusine 4% During Vascular Surgery

NCT06474052 | Completed DMC FDA Drug

• 1 other identifier: 1391
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Electrolyte Disorders

Keywords

colloid; volume kinetics; Gelofusine 4%

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gelofusine 4%

Adult patients undergoing uncomplicated vascular surgery.

Drug: Gelofusine 4%

Interventions

Gelofusine 4% DRUG

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

Also known as: Colloid

Gelofusine 4%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (1)

Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu

Bucharest, București, 022328, Romania

Location

Related Publications (1)

• Balan C, Boros C, Bubenek-Turconi SI, Hahn RG. Volume Kinetics of Gelofusine 4% During Vascular Surgery. Clin Pharmacokinet. 2025 Apr;64(4):599-610. doi: 10.1007/s40262-025-01500-9. Epub 2025 Mar 23.

  PMID: 40121598 DERIVED

MeSH Terms

Interventions

Colloids

Intervention Hierarchy (Ancestors)

Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Robert Hahn, Professor

  Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: April 15, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

RO (1)