Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Intravenous Fluid Volume in the ICU
研究概览
简要总结
This study aims to compare two different methods for guiding intravenous (IV) fluid therapy in patients during their first 6 hours in the ICU after major abdominal surgery. The goal is to determine which method leads to a more optimal and precise amount of fluid administration. The objective is to compare the total fluid volumes administered when guided by Cardiac Index versus Central Venous Pressure, as well as mortality, length of stay, relaparotomy and reintubation in order to identify the more precise fluid management strategy for postoperative ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 65 years.
- •Patients with a Body Mass Index (BMI) between 18 and 30 kg/m².
- •Patients undergoing elective major abdominal surgery with a planned postoperative admission to the ICU.
- •Patients with an American Society of Anesthesiologists (ASA) physical status classification of I to III.
排除标准
- •Patients with pre-operative cardiovascular disorders (Coronary Artery Disease, or heart failure NYHA Class III and IV).
- •Patients with severe renal impairment (Chronic Kidney Disease Stage V) with or without hemodialysis and fluid restrictions.
- •Non-sinus cardiac rhythm.
- •Pregnancy.
- •Patients with right heart failure (patients with signs of congestion and symptoms of right heart failure accompanied by evidence of reduced right ventricular function, indicated by TAPSE < 17 mm).
- •Patients with pulmonary hypertension (patients with echocardiographic suspicion of tricuspid regurgitation, tricuspid regurgitation velocity > 3.4 m/s, or mean pulmonary artery pressure > 20 mmHg from right heart catheterization).
- •Patients with Acute Respiratory Distress Syndrome (ARDS) or patients requiring specialized ventilation modes.
- •Patients who refuse to participate in the study.
结局指标
主要结局
Total Intravenous Fluid Volume in the ICU
时间窗: From ICU enrollment until ICU discharge, up to 30 days
The cumulative volume of intravenous fluids administered, recorded for both the initial 6-hour study period and the total ICU stay. Data will be obtained from ICU charts and recorded as a numerical value (mL).
次要结局
- ICU Mortality(From ICU enrollment until ICU discharge, up to 30 days)
- ICU Length of Stay(From ICU enrollment until ICU discharge, up to 30 days)
- Relaparotomy(From ICU enrollment until ICU discharge, up to 30 days)
- Reintubation(From ICU enrollment until ICU discharge, up to 30 days)
研究者
Sidharta K. Manggala
Principal investigator
Indonesia University