Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Phase 3

Completed

• Conditions: Kidney Transplantation, Mannitol
• Interventions: Drug: Mannitol

• Registration Number: NCT02705573
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-10
• Study Start: 2018-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

all patients with end stage renal diseases -

Exclusion Criteria

Patients younger than 18 years of age or older than 80, alergy to mannitol, Pregnancy, Breast-feed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nacl 0.9%	Mannitol	NaCl 0.9% 5ml/ kg BW
Mannitol 20%	Mannitol	Mannitol 1g/ kg BW

Primary Outcome Measures

Name	Time	Method
renal biomark	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.

Secondary Outcome Measures

Name	Time	Method
oxidation-reduction potential (ORP) of mannitol	24 hours	static ORP (sORP), capacity ORP (cORP)
renal function parameter	24 hours	creatinine, blood urea, nitrogen, urinary output, potassium

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria