A Prospective, Randomized, Double Blinded, Placebo Control Trial to Evaluate Efficacy of Intravenous Mannitol Use During Cadaveric Kidney Transplantation Prior to Kidney Reperfusion
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Urine Output ml per day
研究概览
简要总结
We propose a placebo controlled randomized study on the use of mannitol as an agent to protect against delayed graft function, during the surgical procedure of kidney transplantation from a cadaver. Patients undergoing kidney transplantation for the treatment of end stage kidney disease will be randomized in a ratio of 1:1 to receive either intravenous mannitol or saline during their procedure, administered prior to renal artery clamp release and reperfusion of the kidney. Changes in renal function following surgery and the incidence and duration of delayed graft function (DGF) will be monitored using calculated glomerular filtration rate (eGFR) and the need for dialysis performed post-operatively, as part of routine standard of care. Additionally biological samples will be collected and analyzed for use of a non invasive biomarker for delayed graft function.
详细描述
This study is a prospective randomized double-blind placebo-controlled trial comparing renal function outcomes in patients undergoing cadaver donor renal transplant for end stage kidney failure. Patients will be randomized to receive 0.5 g / kg body weight, of mannitol or saline 0.9% as an intravenous infusion to be initiated and be completely infused within 15-30 minutes prior to vascular clamp removal of the transplanted renal artery.
Prior to surgery, all study participants will receive standard departmental treatment as all other patients undergoing a kidney transplantation from a cadaver.
Upon arrival to the operating room patients will be placed supine on the operating room table, and will be connected to an anesthesia monitor which will include monitoring the HR, blood pressure, saturation, temperature and ECG as standard departmental procedure. After connecting the participant to the anesthesia monitor an IV line will be inserted, as is standard clinical practice. In addition, venous central line catheter for central venous pressure monitoring and specific inotropic drugs infusion, as well as arterial line catheter for blood pressure monitoring, will be initialized upon anesthesiologist team decision The technique of kidney transplantation is well-standardized . None of the techniques utilized in the study are considered experimental and all are considered standard therapeutic options for a patient undergoing cadaveric donor kidney transplantation. The procedures are performed under general anesthesia with non-invasive intraoperative vital sign monitoring, as is standard departmental practice. Study participation will not affect anesthesia method or protocol treatment in anyway.
Upon study enrollment patients will be randomized in 1:1 ratio for study arm treatment/control. The perioperative team, investigator and patient will be blinded to the intervention.
Study arm: Patients randomized to receive the treatment arm will receive 0.5 g / kg body weight of mannitol. The mannitol solution used in the hospital contain 18% mannitol in 500ml solution. An equivocal volume of 2.8 cc / kg body weight, which will be given intravenously with the use of an Ivac pump, infused for a duration of 15 minutes through an existing peripheral intravenous access catheter within 15-30 minutes prior to renal artery reperfusion.
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
- Double (Participant, Investigator)
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
- •Age >18 years
- •Patients on the list of cadaveric donor kidney transplantation
排除标准
- •Allergy to mannitol
- •Allergy to furosemide
- •Combined major surgical cases that may include transplantation of another organ on the same time, such as liver.
- •Severe congestive heart failure (ejection fraction < 30%)
- •Patients with coagulation disorders.
- •Patients who are not able to sign an informed consent
研究组 & 干预措施
Patients randomized to receive the treatment arm of mannitol.
The mannitol solution used in the hospital contain 18% mannitol in 500ml solution. An equivocal volume of 2.8 cc / kg body weight, which will be given intravenously with the use of an Ivac pump, infused for a duration of 15 minutes through an existing peripheral intravenous access catheter within 15-30 minutes prior to renal artery reperfusion
干预措施: Mannitol (Drug)
(Control arm) Study participants will receive a 0.9% saline solution
(Control arm) Study participants randomized to this arm will receive a 0.9% saline solution at a dose of 2.8 cc / kg, infused within 15-30 minutes prior to renal artery reperfusion through an existing intravenous access catheter (either through an central or peripheral intravenous infusion).
干预措施: Saline (Drug)
结局指标
主要结局
Urine Output ml per day
时间窗: Within 7 days postoperatively.
Creatinine value
时间窗: All 7 days postoperatively
Incidence of dialysis after surgery
时间窗: within 7 days postoperatively
次要结局
未报告次要终点
