Overview

This trial has been completed.

Condition kidney failure
Treatment esophageal doppler monitor
Sponsor University Health Network, Toronto
Start date June 2012
End date September 2015
Trial size 50 participants
Trial identifier NCT02512731, REB 11-0055-A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
The esophageal doppler monitor directs the fluid therapy.
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.
(No Intervention)
The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.