Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- renal biomark
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nacl 0.9%
NaCl 0.9% 5ml/ kg BW
Intervention: Mannitol (Drug)
Mannitol 20%
Mannitol 1g/ kg BW
Intervention: Mannitol (Drug)
Outcomes
Primary Outcomes
renal biomark
Time Frame: 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 Outcomes
- oxidation-reduction potential (ORP) of mannitol(24 hours)
- renal function parameter(24 hours)
Investigators
Samir Sljivic
Dr.
Medical University of Vienna