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Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

NCT ID: NCT02512731

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Goal directed fluid therapy using esophageal doppler monitor

The esophageal doppler monitor directs the fluid therapy.

Group Type ACTIVE_COMPARATOR

Esophageal Doppler Monitor

Intervention Type 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.

Fluid therapy using standard management

The esophageal doppler monitor is in place however blinded to the healthcare providers, fluid management is as per standard clinical practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Corbella D, Toppin PJ, Ghanekar A, Ayach N, Schiff J, Van Rensburg A, McCluskey SA. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial. Can J Anaesth. 2018 Aug;65(8):873-883. doi: 10.1007/s12630-018-1118-y. Epub 2018 Apr 10.

Reference Type DERIVED
PMID: 29637407 (View on PubMed)

Other Identifiers

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REB 11-0055-A

Identifier Type: -

Identifier Source: org_study_id