Effects of mannitol on kidney function after kidney transplantation

Effects of mannitol on delayed graft function after cadaveric renal transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005391-29-AT

Enrollment

Registered

2015-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation

Interventions

Product Name: Mannitol Pharmaceutical Form: Infusion INN or Proposed INN: MANNITOL Other descriptive name: MANNITOL Concentration unit: % percent Concentration type: equal Concentration number: 20- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All Patient with end stage renal disease between 18-80 year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Alergy to mannitol

Design outcomes

Primary

Measure	Time frame
Main Objective: Effects of mannitol on delayed graft function after cadaveric renal transplantation;Secondary Objective: Effects of mannitol on kidney function after kidney transplantation;Primary end point(s): A biomarker panel using xMAP Luminex (multi-analyte profiling) technology is used as the primary endpoint containing following parameters: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18. ;Timepoint(s) of evaluation of this end point: The biomarker panel will be determined by using blood samples taken before start of anesthesia and 24 hours after reperfusion of the donor organ.	—

Measure

Time frame

Main Objective: Effects of mannitol on delayed graft function after cadaveric renal transplantation;Secondary Objective: Effects of mannitol on kidney function after kidney transplantation;Primary end point(s): A biomarker panel using xMAP Luminex (multi-analyte profiling) technology is used as the primary endpoint containing following parameters: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18. ;Timepoint(s) of evaluation of this end point: The biomarker panel will be determined by using blood samples taken before start of anesthesia and 24 hours after reperfusion of the donor organ.

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Secondary

Measure	Time frame
Secondary end point(s): 1. The following laboratory values will be recording during hospital stay only when available or needed by the attending physician: creatinine, blood urea nitrogen, urinary output 2. Oxygen radical parameters will be determines using the RedoxSYS(R) system. ;Timepoint(s) of evaluation of this end point: Oxygen radical parameters will be determined at following timepoints: 1) preoperative 2) after bolus administration of the study medication 3) 24 hours after reperfusion of the donor organ	—

Measure

Time frame

Secondary end point(s): 1. The following laboratory values will be recording during hospital stay only when available or needed by the attending physician: creatinine, blood urea nitrogen, urinary output 2. Oxygen radical parameters will be determines using the RedoxSYS(R) system. ;Timepoint(s) of evaluation of this end point: Oxygen radical parameters will be determined at following timepoints: 1) preoperative 2) after bolus administration of the study medication 3) 24 hours after reperfusion of the donor organ

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Countries

Austria

Contacts

Public ContactHead Office

Medical University of Vienna

sekretariat-anaesthesie@meduniwien.ac.at004314040041020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026