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

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ClinicalTrials.gov Identifier: NCT01485432
Recruitment Status : Unknown
Verified January 2013 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : December 5, 2011
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
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 or disease Intervention/treatment
Renal Transplant Surgery Device: PiCCO® Monitoring

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.


Study Type : Observational
Estimated Enrollment : 98 participants
Time Perspective: Prospective
Official Title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?
Study Start Date : October 2011
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. delayed graft function [ Time Frame: Start of anesthesia until day 7 after the operation ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01485432     History of Changes
Other Study ID Numbers: IROR
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Technische Universität München:
Renal transplant surgery
hemodynamic management
PiCCO
delayed graft function