Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Kidney Transplantation, Mannitol Clinical Trial

Official title:

Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705573
• Other study ID #: 2021/2014
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: November 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function
• Kidney Transplantation, Mannitol

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	renal function parameter	creatinine, blood urea, nitrogen, urinary output, potassium	24 hours
Secondary	oxidation-reduction potential (ORP) of mannitol	static ORP (sORP), capacity ORP (cORP)	24 hours