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Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery (IROR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Technische Universität München.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: November 11, 2011
Last updated: January 16, 2013
Last verified: January 2013
This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Condition Intervention
Renal Transplant Surgery
Device: PiCCO® Monitoring

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • delayed graft function [ Time Frame: Start of anesthesia until day 7 after the operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Groups/Cohorts Assigned Interventions
P group
Group P: Fluid Management according to measurements with PiCCO®
Device: PiCCO® Monitoring
Fluid and vasopressor management according to PiCCO measurements
C group
Group C: Conventional fluid management

Detailed Description:

Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.

Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing renal transplant surgery

Inclusion Criteria:

  • Renal Transplant Surgery
  • Age ≥ 65 years
  • Written informed consent

Exclusion Criteria:

  • Contraindications for an arterial line in the femoral artery:

    • stents
    • bypasses
    • severe peripheral artery occlusive disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT01485432

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Bettina Jungwirth, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
  More Information

Responsible Party: Technische Universität München Identifier: NCT01485432     History of Changes
Other Study ID Numbers: IROR 
Study First Received: November 11, 2011
Last Updated: January 16, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Renal transplant surgery
hemodynamic management
delayed graft function processed this record on December 09, 2016