Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02705573
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2016-03-07
Brief Title:
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RedoxSYSsystem
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 09 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
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 09 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None