Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Delayed graft function
研究概览
简要总结
Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end-stage renal disease aged 18 years or above
排除标准
- •simultaneous multiple organ transplantation
- •known allergy to study medication
- •known pregnancy status
- •cancellation of surgery due to grafts or personal reasons
- •persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
- •any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study
研究组 & 干预措施
Terlipressin + Dopamine
Participants assigned to the intervention group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, terlipressin was administered in addition to standard hemodynamic management.
干预措施: terlipressin (Drug)
Placebo (normal saline) + Dopamine
Participants assigned to the placebo comparator group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, placebo (normal saline) was administered using the same preparation, administration procedure, and infusion rate as in the intervention group to maintain blinding.
干预措施: Placebo (Normal Saline) (Drug)
结局指标
主要结局
Delayed graft function
时间窗: within the first 7 days after op
need kidney replacement in the first 7 days after op
次要结局
- Serum creatinine after kidney transplantation at 3 months and 1 year(3 months and 1 year after kidney transplantation)
- Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year(3 months and 1 year after kidney transplantation)