Volume Kinetics of Gelofusine 4% During Uncomplicated Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Plasma Volume
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Known allergy to 4% Gelofusine.
- •Patient refusal to participate in the study.
- •Non-elective/emergency surgical interventions.
- •The American Society of Anesthesiologists (ASA) >
- •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.
研究组 & 干预措施
Gelofusine 4%
Adult patients undergoing uncomplicated vascular surgery.
干预措施: Gelofusine 4% (Drug)
结局指标
主要结局
Plasma Volume
时间窗: 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.
次要结局
未报告次要终点
研究者
Balan Ion Cosmin
Principal Investigator
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu