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

January 10, 2020 updated by: Technical University of Munich

Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 81675
        • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing renal transplant surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delayed graft function
Time Frame: Start of anesthesia until day 7 after the operation
Start of anesthesia until day 7 after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Bettina Jungwirth, MD, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

November 11, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IROR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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