Volume Kinetics of Gelofusine 4% During Vascular Surgery

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

Status: Completed

Conditions: Fluid Electrolyte Disorders

Treatments: Drug: Gelofusine 4%

Study type: Observational

Funder types: Other

Identifiers

NCT06474052

1391

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Gelofusine 4%

Description:

Adult patients undergoing uncomplicated vascular surgery.

Treatment:

Drug: Gelofusine 4%