Effects of mannitol on kidney function after kidney transplantatio

Phase 1

Conditions: Kidney transplantation
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-005391-29-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

All Patient with end stage renal disease between 18-80 year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Alergy to mannitol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effects of mannitol on delayed graft function after<br>cadaveric renal transplantation;Secondary Objective: Effects of mannitol on kidney function after kidney transplantation;Primary end point(s): A biomarker panel using xMAP Luminex (multi-analyte profiling) technology is used as the primary endpoint containing following parameters: <br>CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18.<br>;Timepoint(s) of evaluation of this end point: The biomarker panel will be determined by using blood samples taken before start of anesthesia and 24 hours after reperfusion of the donor organ.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The following laboratory values will be recording during hospital stay only when available or needed by the attending physician: creatinine, blood urea nitrogen, urinary output<br><br>2. Oxygen radical parameters will be determines using the RedoxSYS(R) system. <br>;Timepoint(s) of evaluation of this end point: Oxygen radical parameters will be determined at following timepoints: <br>1) preoperative <br>2) after bolus administration of the study medication<br>3) 24 hours after reperfusion of the donor organ