NCT06474052

Volume Kinetics of Gelofusine 4% During Vascular Surgery

Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Fluid Electrolyte Disorders

Interventions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-03-31
• Completion: 2024-04-15
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

1 site across 1 country: Romania

Regulatory

• FDA-regulated drug study