NCT02705573

Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Transplantation, Mannitol

Interventions

Type	Name	Description
DRUG	Mannitol	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. The study medication will be administered immediately before organ reperfusion. The follow-up of the study is 24 hours.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-06-30
• Completion: 2018-07-30
• First posted: 2016-03-10
• Last updated: 2018-11-07

Locations

1 site across 1 country: Austria