Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Kidney Failure Clinical Trial

— EDM  

Official title:

Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512731
• Other study ID #: REB 11-0055-A
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: December 2, 2016
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Device:
• Esophageal Doppler Monitor
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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume of crystalloid solutions administered intraoperatively.		Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours	No