Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery

Renal Transplant Surgery Clinical Trial

— IROR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01485432
• Other study ID #: IROR
• Status: Terminated
• Start date: October 2011
• Est. completion date: October 2019

Study information

• Verified date: January 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2019
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Surgery

Intervention

Device:
• PiCCO® Monitoring
Fluid and vasopressor management according to PiCCO measurements

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. Epub 2006 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delayed graft function		Start of anesthesia until day 7 after the operation