Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02512731

Acronym

EDM

Enrollment

Registered

2015-07-31

Start date

2012-06-30

Completion date

2016-12-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

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.

Interventions

DEVICEEsophageal 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026