Intraoperative Fluid Therapy for Deceased Donor Renal Transplantation

NCT02512731 | Completed

• 1 other identifier: REB 11-0055-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (1)

• The volume of crystalloid solutions administered intraoperatively.

  Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours

Study Arms (2)

Goal directed fluid therapy using esophageal doppler monitor

ACTIVE COMPARATOR

The esophageal doppler monitor directs the fluid therapy.

Device: Esophageal Doppler Monitor

Fluid therapy using standard management

NO INTERVENTION

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

Interventions

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.

Goal directed fluid therapy using esophageal doppler monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years
• signed informed consent
• listed for deceased donor transplantation.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29637407 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: July 31, 2015
• Study Start: June 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

CA (1)