Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery

NCT ID: NCT01485432

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2019-10-31

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.

Conditions

Renal Transplant Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

P group

Group P: Fluid Management according to measurements with PiCCO®

PiCCO® Monitoring

Intervention Type: DEVICE

Fluid and vasopressor management according to PiCCO measurements

C group

Group C: Conventional fluid management

No interventions assigned to this group

Interventions

PiCCO® Monitoring

Fluid and vasopressor management according to PiCCO measurements

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Jungwirth, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München

Locations

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Countries

Germany

References

Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.

Reference Type: BACKGROUND

PMID: 17119923 (View on PubMed)

Boom H, Mallat MJ, de Fijter JW, Zwinderman AH, Paul LC. Delayed graft function influences renal function, but not survival. Kidney Int. 2000 Aug;58(2):859-66. doi: 10.1046/j.1523-1755.2000.00235.x.

Reference Type: BACKGROUND

PMID: 10916111 (View on PubMed)

Other Identifiers

IROR

Identifier Type: -

Identifier Source: org_study_id