Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Not Applicable

Completed

• Conditions: Kidney Failure
• Interventions: Device: Esophageal Doppler Monitor

• Registration Number: NCT02512731
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Primary Completion: 2015-09
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Goal directed fluid therapy using esophageal doppler monitor	Esophageal Doppler Monitor	The esophageal doppler monitor directs the fluid therapy.

Primary Outcome Measures

Name	Time	Method
The volume of crystalloid solutions administered intraoperatively.	Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada