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Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation (EDM)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Kidney Failure

Treatments

Device: Esophageal Doppler Monitor

Study type

Interventional

Funder types

Other

Identifiers

NCT02512731
REB 11-0055-A

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

50 participants in 2 patient groups

Goal directed fluid therapy using esophageal doppler monitor
Active Comparator group
Description:
The esophageal doppler monitor directs the fluid therapy.
Treatment:
Device: Esophageal Doppler Monitor
Fluid therapy using standard management
No Intervention group
Description:
The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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