NCT01485432

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

November 11, 2011

Last Update Submit

January 10, 2020

Conditions

Renal Transplant Surgery

Keywords

Renal transplant surgeryhemodynamic managementPiCCOdelayed graft function

Outcome Measures

Primary Outcomes (1)

  • delayed graft function

    Start of anesthesia until day 7 after the operation

Study Arms (2)

P group

Group P: Fluid Management according to measurements with PiCCO®

Device: PiCCO® Monitoring

C group

Group C: Conventional fluid management

Interventions

PiCCO® MonitoringDEVICE

Fluid and vasopressor management according to PiCCO measurements

P group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing renal transplant surgery

You may qualify if:

  • Renal Transplant Surgery
  • Age ≥ 65 years
  • Written informed consent

You may not qualify if:

  • Contraindications for an arterial line in the femoral artery:
  • stents
  • bypasses
  • severe peripheral artery occlusive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 81675, Germany

Location

Related Publications (2)

  • 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.

    PMID: 17119923BACKGROUND

  • 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.

    PMID: 10916111BACKGROUND

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bettina Jungwirth, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2011

First Posted

December 5, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

DE(1)