NCT04835038招募中4 期
Effects of Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection on Postoperative Acute Kidney Injury in Patients Undergoing Major Abdominal Surgery: a Randomized, Controlled, Open-label Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- Postoperative acute renal injury
研究概览
简要总结
- Title: Effects of Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection on postoperative acute kidney injury in patients undergoing major abdominal surgery: a randomized, controlled, open-label clinical study
- Objective: To evaluate the effect of BRS and LRS infusion on acute renal injury in patients undergoing major abdominal surgery
- Primary outcome: Incidence of AKI at 28 days postoperative (defined as acute kidney injury, according to Kidgo 2012 definition and classification).
- Study Design: Randomized, controlled, open-label clinical study.
详细描述
- Subjects: patients who planned to undergo elective major abdominal surgery.
- Study data collection period: Subjects signed the consent form until 28 days after discharge or died in hospital or withdrew from the study.
- Number of research centers/sample size: 3400 patients were planned to be included.
- Study process: Among patients undergoing elective surgery, the researchers will include patients who meet the inclusion criteria for elective major abdominal surgery and agree to participate in the study. The data to be collected in this study will be recorded by the researcher in the eCRF, including:
(1) Data to be collected during the screening period and preoperatively: patients' basic characteristics and demographic data (2) Data to be recorded during and/or after surgery: primary study indicators, secondary indicators, and other indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grade Ⅰ-Ⅲ.
- •patients aged between 20 and 70, signed informed consent form, and are willing to participate in the study.
- •BMI ≤ 30kg/m
- •elective major abdominal surgery for the first time (radical resection of ovarian cancer, radical resection of cervical cancer, radical resection of gastric cancer, radical resection of colorectal cancer, radical resection of bladder tumor and radical resection of prostate tumor).
- •NYHA cardiac function grade Ⅰ-Ⅲ.
- •the function of liver and kidney is normal before operation.
- •the blood coagulation function was normal before operation.
- •hemoglobin > 70g/L.
- •sinus rhythm was detected by electrocardiogram and there were no other malignant arrhythmias.
排除标准
- •Emergency surgery.
- •liver and kidney surgery.
- •complicated with chronic respiratory diseases and FEV1/FVC < 70%.
- •the operation time is less than 2 hours.
- •patients with mental illness or cognitive impairment.
- •uncontrolled hypertension with blood pressure higher than 180 × 100mmHg.
- •patients with hypothyroidism.
- •pregnant or lactating patients. -
研究组 & 干预措施
Sodium Bicarbonate Ringer's Injection group
Experimental
Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)
干预措施: Sodium Bicarbonate Ringer's Injection (Drug)
Sodium Lactated Ringer's Injection group
Active Comparator
Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)
干预措施: Sodium Lactated Ringer's Injection (Drug)
结局指标
主要结局
Postoperative acute renal injury
时间窗: 28 days after surgery
The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)
次要结局
未报告次要终点
研究者
Shiyong Li
Principal Investigator, Associate professor
Tongji Hospital
研究点 (1)
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