Organ Transplantation Clinical Trial
— RIPNODOfficial title:
Remote Ischemic Preconditioning in Neurological Death Organ Donors
NCT number | NCT01515072 |
Other study ID # | 0120110125 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | April 2015 |
Verified date | November 2018 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 321 |
Est. completion date | April 2015 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria: 1. Neurological death donors in whom brain death determination is imminent 2. First person consent or next of kin consent for research 3. Donors >=6 years of age 4. Organ recovery not expected within 6 hours of consent. 5. Both sexes and ethnicities. Exclusion Criteria: 1. Donation after cardiac death donors (DCD) 2. Live organ donors 3. No first person consent and next of kin decline research consent 4. Donor Age < 6 years 5. Lower extremity trauma or recent amputation 6. Tissue only donors |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers, The State University of New Jersey | Newark | New Jersey |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | Health Resources and Services Administration (HRSA), The University of Texas Health Science Center at San Antonio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Organs Recovered Per Donor | Number of organs recovered per organ donor | At time of organ recovery, up to 1 day | |
Secondary | Number of Organs Transplanted Per Donor | Number of organs transplanted from each organ donor | Within 24 hours of organ recovery | |
Secondary | Change in Vasopressor Score | Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram. Here we will present data for the change in vasopressor use evaluated using a vasopressor score. A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322): Vasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100). The range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor. |
Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours | |
Secondary | Change in Serum Lactate | Change in serum lactate levels (mg/dL) from before intervention to the final value | Subjects will be followed from admission to explantation, an average of 4.5 days | |
Secondary | Change in Creatinine Clearance | Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value | Subjects will be followed from admission to explantation, an average of 4.5 days | |
Secondary | Change in P:F Ratio | Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value | Subjects will be followed from admission to explantation, an average of 4.5 days | |
Secondary | Change in Dynamic Compliance | Change in dynamic compliance of the lung from before intervention to terminal value Cdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure: Cdyn= Vt/PIP - PEEP |
Subjects will be followed from admission to explantation, an average of 4.5 days | |
Secondary | Change in Troponins | Change in serum troponin I (ng/mL) from before intervention to terminal value | Subjects will be followed from admission to explantation, an average of 4.5 days | |
Secondary | Pulsatile Perfusion Flow | Perfusate flow (mL/min) in machine perfused kidneys. | Up to 24 hours of machine perfusion | |
Secondary | Six Month Hospital Free Survival of All Organ Recipients | Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant. | 6 months post-transplant | |
Secondary | Delayed Graft Function (DGF) of Kidney Recipients. | DGF is defined as the need for dialysis within the first week post transplantation. | 7 days post-transplant | |
Secondary | Pulsatile Perfusion Parameters | Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys. | Up to 24 hours of machine perfusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00987103 -
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
|
Phase 1 | |
Completed |
NCT03699839 -
Reducing the Burden of Influenza After Solid-Organ Transplantation
|
Phase 2/Phase 3 | |
Completed |
NCT01633424 -
The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
|
||
Completed |
NCT01254955 -
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
|
N/A | |
Completed |
NCT00948883 -
Study of Cancers After Solid Organs Transplants
|
N/A | |
Recruiting |
NCT02314949 -
Leuven Tolerogenic Protocol for Intestinal Transplantation
|
N/A | |
Recruiting |
NCT01283295 -
Immune Monitoring and Assay Development in Organ Transplant Recipients
|
||
Not yet recruiting |
NCT03861962 -
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level
|
||
Completed |
NCT01123187 -
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
|
N/A | |
Completed |
NCT00213304 -
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
|
Phase 3 | |
Completed |
NCT00904579 -
Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
|
||
Recruiting |
NCT04687865 -
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
|
||
Recruiting |
NCT00611494 -
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
|
Phase 4 | |
Completed |
NCT02852902 -
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
|
||
Completed |
NCT05685888 -
Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
|
||
Recruiting |
NCT00792064 -
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
|
N/A | |
Completed |
NCT00734396 -
Mesenchymal Stem Cells and Subclinical Rejection
|
Phase 1/Phase 2 | |
Completed |
NCT00286871 -
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
|
Phase 1 | |
Recruiting |
NCT03997253 -
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
|
N/A | |
Recruiting |
NCT01256931 -
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
|
N/A |