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

This study is currently recruiting participants.
Verified January 2013 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01485432
First received: November 11, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing renal transplant surgery

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485432

Contacts
Contact: Bettina Jungwirth, MD +49 89 4140 ext 4291 b.jungwirth@lrz.tum.de

Locations
Germany
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München Recruiting
Munic, Bavaria, Germany, 81675
Contact: Bettina Jungwirth, MD     +49 89 4140 ext 4291     b.jungwirth@lrz.tum.de    
Principal Investigator: Bettina Jungwirth, MD            
Sub-Investigator: Manfred Blobner, MD            
Sub-Investigator: Barbara Kapfer, MD            
Sub-Investigator: Sebastian Schmid, MD            
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Bettina Jungwirth, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
  More Information

Publications:

Responsible Party: Technische Universität München
ClinicalTrials.gov 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
PiCCO
delayed graft function

ClinicalTrials.gov processed this record on May 22, 2013