Remote Ischemic Preconditioning in Neurological Death Organ Donors

NCT01515072 | Completed Results

• 1 other identifier: 0120110125
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes. Neurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.

Conditions

Organ Transplantation

Keywords

Remote Ischemic Preconditioning; Brain death organ donors; Delayed graft function; Donor management; Pulsatile perfusion

Outcome Measures

Primary Outcomes (1)

• Number of Organs Recovered Per Donor

  Number of organs recovered per organ donor

  At time of organ recovery, up to 1 day

Secondary Outcomes (11)

• Number of Organs Transplanted Per Donor

  Within 24 hours of organ recovery

• Change in Vasopressor Score

  Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours

• Change in Serum Lactate

  Subjects will be followed from admission to explantation, an average of 4.5 days

• Change in Creatinine Clearance

  Subjects will be followed from admission to explantation, an average of 4.5 days

• Change in P:F Ratio

  Subjects will be followed from admission to explantation, an average of 4.5 days

Study Arms (2)

No Remote Ischemic Preconditioning

NO INTERVENTION

The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.

Remote Ischemic Preconditioning

EXPERIMENTAL

The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.

Other: RIPC (Remote Ischemic Preconditioning)

Interventions

RIPC (Remote Ischemic Preconditioning) OTHER

Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.

Remote Ischemic Preconditioning

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurological death donors in whom brain death determination is imminent
• First person consent or next of kin consent for research
• Donors \>=6 years of age
• Organ recovery not expected within 6 hours of consent.
• Both sexes and ethnicities.

You may not qualify if:

• Donation after cardiac death donors (DCD)
• Live organ donors
• No first person consent and next of kin decline research consent
• Donor Age \< 6 years
• Lower extremity trauma or recent amputation
• Tissue only donors

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Health Resources and Services Administration (HRSA): collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (2)

Rutgers, The State University of New Jersey

Newark, New Jersey, 07101, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1\) Bias from variation in the intervention between two sites; 2) Lack of blinding; 3) Inadequate data precludes analyses of ejection fraction; 4) Data on some of the other secondary outcomes were not available for all donors.

Results Point of Contact

• Title: Baburao Koneru, MD, MPH
• Organization: Rutgers-New Jersey Medical School

koneruba@njms.rutgers.edu

(973) 972-9599

Study Officials

• Baburao Koneru, MD

  University of Medicine and Dentistry New Jersey-Newark

  PRINCIPAL INVESTIGATOR

• William K Washburn, MD

  University of Texas Health Sciences at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, New Jersey Medical School

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: January 23, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: April 1, 2015
• Last Updated: December 19, 2018
• Results First Posted: June 20, 2017

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)