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Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Primary Purpose

Kidney Transplantation, Mannitol

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Mannitol
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation, Mannitol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

-

Sites / Locations

  • Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mannitol 20%

Nacl 0.9%

Arm Description

Mannitol 1g/ kg BW

NaCl 0.9% 5ml/ kg BW

Outcomes

Primary Outcome Measures

renal biomark
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
creatinine, blood urea, nitrogen, urinary output, potassium
oxidation-reduction potential (ORP) of mannitol
static ORP (sORP), capacity ORP (cORP)

Full Information

First Posted
March 7, 2016
Last Updated
November 5, 2018
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02705573
Brief Title
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Official Title
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Mannitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mannitol 20%
Arm Type
Experimental
Arm Description
Mannitol 1g/ kg BW
Arm Title
Nacl 0.9%
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9% 5ml/ kg BW
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
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.
Primary Outcome Measure Information:
Title
renal biomark
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
renal function parameter
Description
creatinine, blood urea, nitrogen, urinary output, potassium
Time Frame
24 hours
Title
oxidation-reduction potential (ORP) of mannitol
Description
static ORP (sORP), capacity ORP (cORP)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
32966587
Citation
Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kabon B. The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):162-168. doi: 10.1111/aas.13713. Epub 2020 Oct 15.
Results Reference
derived
PubMed Identifier
32723374
Citation
Reiterer C, Hu K, Sljivic S, Falkner von Sonnenburg M, Fleischmann E, Kainz A, Kabon B. Mannitol and renal graft injury in patients undergoing deceased donor renal transplantation - a randomized controlled clinical trial. BMC Nephrol. 2020 Jul 28;21(1):307. doi: 10.1186/s12882-020-01961-z.
Results Reference
derived

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Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

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