Clinical Effects of Ringers Lactate Versus Sterofundin/Plasmalyte Solution in Surgical Adult Patients With Sepsis; a Comparative Study in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- serum lactate
研究概览
简要总结
The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/ Plasmalyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic.
The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.
详细描述
The goal of this clinical trial is to compare the clinical effects of using Ringer's Lactate and Sterofundin/PlasmaLyte as maintenance fluids in adult patients who have undergone abdominal surgery and are septic.
The primary outcome will be the change in serum lactate levels. Secondary outcomes will include renal function parameters, qSOFA scores, and the incidence of postoperative complications within the first 72 hours following surgery.
The main questions it aims to answer are:
- Does the choice of fluid produce different outcomes in this patient population?
- If yes, then which fluid produces better outcomes?
Enrolled patients will be randomly assigned Ringer's Lactate or Sterofundin for intravenous infusion. The volume, infusion rate and additive content will be determined by the treating clinicians. The intervention will last for 72 hours after patients' enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Underwent Abdominal Surgery and postoperative length of stay is more than 24 hours
- •ASA 1 to 4
- •Diagnosis of sepsis (qSOFA score 2 or more)
排除标准
- •Patients with Renal failure/hepatic failure/severe metabolic acidosis
- •Patients requiring renal replacement therapy prior to enrolment
- •Patients with suspected poisoning
- •Pregnant women
- •Patients having solitary kidney
研究组 & 干预措施
Ringer's Lactate Group
This group will receive RInger's Lactate as maintenance fluid.
干预措施: Ringer's Lactate Crystalloid Solutions (Other)
Steroundin Group
This group will receive Sterofundin as maintenance fluid.
干预措施: Sterofundin (Bolus of crystalloids) (Other)
结局指标
主要结局
serum lactate
时间窗: Samples will be collected at baseline (preoperatively or immediately postoperatively) and at predefined intervals during the postoperative period (e.g., 24 and 48 hours after surgery).
Measurement: Serum lactate levels will be measured from blood samples. Method: Standard laboratory assays will be used to quantify lactate concentration. Purpose: To assess the effect of maintenance fluids (Ringer's Lactate vs. Sterofundin) on lactate clearance and tissue perfusion in septic adult patients following abdominal surgery. Units: mmol/L
次要结局
未报告次要终点