Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- renal biomark
研究概览
简要总结
In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect of mannitol on perioperative redox status in patients receiving renal transplantation using the oxidation-reduction potentials assessed with the RedoxSYS®system.
We are planning to perform a double-blind randomized controlled trial. In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined befor induction of anesthesia and 24 hours after administration of study medication: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18.
Furthermore we want to perform sORP and cORP before induction of anesthesia, just before bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery room.
Data will be collected, compared and published at the end of the study. It is planned to include a total of 34 patients in the study.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •all patients with end stage renal diseases -
排除标准
- •Patients younger than 18 years of age or older than 80, alergy to mannitol, Pregnancy, Breast-feed
研究组 & 干预措施
Mannitol 20%
Mannitol 1g/ kg BW
干预措施: Mannitol (Drug)
Nacl 0.9%
NaCl 0.9% 5ml/ kg BW
干预措施: Mannitol (Drug)
结局指标
主要结局
renal biomark
时间窗: 24 hours
The BM-panel includes the following analytes: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C and Endostatin. Additionally, the BM-panel can be extended for measurement of FGF23, IGFB7, NGAL and IL 18.
次要结局
- oxidation-reduction potential (ORP) of mannitol(24 hours)
- renal function parameter(24 hours)
研究者
Samir Sljivic
Dr.
Medical University of Vienna