Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02705573

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation, Mannitol	Drug: Mannitol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mannitol 20% Mannitol 1g/ kg BW	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.
Placebo Comparator: Nacl 0.9% NaCl 0.9% 5ml/ kg BW	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.

Arm

Intervention/Treatment

Experimental: Mannitol 20%

Mannitol 1g/ kg BW

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.

Placebo Comparator: Nacl 0.9%

NaCl 0.9% 5ml/ kg BW

Drug: Mannitol

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samir Sljivic, Dr., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT02705573

Other Study ID Numbers:

2021/2014

First Posted:

Mar 10, 2016

Last Update Posted:

Nov 7, 2018

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delayed Graft Function

Mannitol

Study Results

No Results Posted as of Nov 7, 2018