search
Back to results

Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation (EDM)

Primary Purpose

Kidney Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Esophageal Doppler Monitor
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age greater than 18 years
  • signed informed consent
  • listed for deceased donor transplantation.

Exclusion Criteria:

  • esophageal surgery or cancer
  • esophageal stricture, varices or diverticulum
  • upper airway surgery
  • coarctation of the aorta
  • significant valvular heart disease
  • clinically significant cardiac arrhythmias
  • patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Goal directed fluid therapy using esophageal doppler monitor

Fluid therapy using standard management

Arm Description

The esophageal doppler monitor directs the fluid therapy.

The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice.

Outcomes

Primary Outcome Measures

The volume of crystalloid solutions administered intraoperatively.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2015
Last Updated
December 2, 2016
Sponsor
University Health Network, Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT02512731
Brief Title
Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Acronym
EDM
Official Title
Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Delayed graft function (DGF) is defined as requirement for dialysis in the first week following kidney transplantation. DGF is a common complication occurring in 39% of the deceased donor renal transplants at the investigators' institution with significant cost and outcome implications. The 3 major risk factors for DGF are donor graft characteristics, recipient factors and perioperative management. The most easily modifiable of these factors is perioperative management, in particular intraoperative fluid therapy. The investigators propose to compare the amount of fluid administered using the current standard of care with the fluid administered when optimizing the cardiac output (CO) using Esophageal Doppler Monitoring (EDM) to guide fluid therapy. EDM measures blood flow in the descending aorta, optimizing stroke volume (SV) and cardiac output (CO) by indicating when fluid administration fails to produce an increase in CO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal directed fluid therapy using esophageal doppler monitor
Arm Type
Active Comparator
Arm Description
The esophageal doppler monitor directs the fluid therapy.
Arm Title
Fluid therapy using standard management
Arm Type
No Intervention
Arm Description
The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice.
Intervention Type
Device
Intervention Name(s)
Esophageal Doppler Monitor
Intervention Description
Esophageal doppler monitoring (EDM) is a minimally invasive means of continuously measuring the cardiac output from the pattern of blood flow in the descending thoracic aorta.
Primary Outcome Measure Information:
Title
The volume of crystalloid solutions administered intraoperatively.
Time Frame
Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age greater than 18 years signed informed consent listed for deceased donor transplantation. Exclusion Criteria: esophageal surgery or cancer esophageal stricture, varices or diverticulum upper airway surgery coarctation of the aorta significant valvular heart disease clinically significant cardiac arrhythmias patient randomized to other trials with an outcome variable of delayed graft function or early graft function will also be excluded
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29637407
Citation
Corbella D, Toppin PJ, Ghanekar A, Ayach N, Schiff J, Van Rensburg A, McCluskey SA. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial. Can J Anaesth. 2018 Aug;65(8):873-883. doi: 10.1007/s12630-018-1118-y. Epub 2018 Apr 10.
Results Reference
derived

Learn more about this trial

Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

We'll reach out to this number within 24 hrs