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OpenTrials
Completed

NCT Number: NCT02512731

Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal Doppler Monitor

Device

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: EDM

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 31, 2015
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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