Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery

Terminated

• Conditions: Renal Transplant Surgery
• Interventions: Device: PiCCO® Monitoring

• Registration Number: NCT01485432
• Lead Sponsor: Technical University of Munich

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2012-10
• Study Completion: 2019-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P group	PiCCO® Monitoring	Group P: Fluid Management according to measurements with PiCCO®

Primary Outcome Measures

Name	Time	Method
delayed graft function	Start of anesthesia until day 7 after the operation

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munic, Bavaria, Germany