Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Conditions
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Kidney Transplantation, Mannitol

Intervention / Treatment
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* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol 20%<br>Mannitol 1g/ kg BW | Drug: Mannitol<br>* 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.<br>|
| Placebo Comparator: Nacl 0.9%<br>NaCl 0.9% 5ml/ kg BW | Drug: Mannitol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function parameter | creatinine, blood urea, nitrogen, urinary output, potassium | 24 hours | 
| oxidation-reduction potential (ORP) of mannitol | static ORP (sORP), capacity ORP (cORP) | 24 hours |