Remote Ischemic Preconditioning in Neurological Death Organ Donors (RIPNOD)
This study is currently recruiting participants.
Verified June 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborators:
Health Resources and Services Administration (HRSA)
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01515072
First received: October 28, 2011
Last updated: June 28, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transplantation |
Other: RIPC (Remote Ischemic Preconditioning) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Remote Ischemic Preconditioning in Neurological Death Organ Donors |
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Number of organs recovered per donor [ Time Frame: At time of organ recovery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of organs transplanted per donor [ Time Frame: Within 24 hours of organ recovery ] [ Designated as safety issue: No ]
- Organ Specific Outcomes [ Time Frame: Subjects will be followed from admission to explantation, an average of 4.5 days ] [ Designated as safety issue: No ]Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, LFTs, P:F ratios, Lung Compliance, Cardiac biomarkers, EF from 2d Echo
- Pulsatile perfusion parameters [ Time Frame: Up to 24 hours of machine perfusion ] [ Designated as safety issue: No ]Perfusate flow and resistance in machine perfused kidneys.
- Six month hospital free survival of all organ recipients [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]
- Delayed Graft function (DGF) of Kidney recipients. [ Time Frame: 7 days post-transplant ] [ Designated as safety issue: No ]DGF is defined as the need for dialysis within the first week post transplantation.
| Estimated Enrollment: | 320 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No RIPC
No intervention will be assigned to this group.
|
|
|
Experimental: RIPC
Remote Ischemic Preconditioning Group
|
Other: RIPC (Remote Ischemic Preconditioning)
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.
|
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515072
Contacts
| Contact: Baburao Koneru, MD | 973-972-9599 | koneruba@umdnj.edu |
| Contact: George Dikdan, PhD | 973-972-6156 | dikdange@umdnj.edu |
Locations
| United States, New Jersey | |
| University of Medicine and Dentistry New Jersey | Recruiting |
| Newark, New Jersey, United States, 07101 | |
| Contact: Baburao Koneru, MD 973-972-9599 koneruba@umdnj.edu | |
| Contact: George Dikdan, PhD 973-972-6156 dikdange@umdnj.edu | |
| Principal Investigator: Baburao Koneru, MD | |
| Sub-Investigator: Amy Davidow, PhD | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Cyndi Tourtellot, RN, BSN, CCRC 210-567-9229 tourtellot@uthscsa.edu | |
| Principal Investigator: William K Washburn, MD | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Health Resources and Services Administration (HRSA)
The University of Texas Health Science Center at San Antonio
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01515072 History of Changes |
| Other Study ID Numbers: | 0120110125 |
| Study First Received: | October 28, 2011 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
Remote Ischemic Preconditioning Brain death organ donors Delayed graft function Donor management Pulsatile perfusion |
ClinicalTrials.gov processed this record on May 21, 2013