Kidney DiseasePhase 3RIPCOTNCT00975702
Remote Ischemic Preconditioning In Abdominal Organ Transplantation
A Phase 3 study testing RIPC by Inflation of Pneumatic Tourniquet in people with Kidney Disease and Liver Disease, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood flow to the lower extremity prior to organ recovery in deceased donors, improve short and long term outcomes after transplantation of kidneys, livers and pancreas? To test this hypothesis deceased organ donors will be… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Kidney Disease, Liver Disease, Pancreas Disease
- What is being tested?
- RIPC by Inflation of Pneumatic Tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All deceased organ donors aged > 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
- DONORS
- Patients who receive a kidney from an enrolled donor at one of the five kidney transplant centers in New Jersey, HUH, NBIMC, SBMC, RWJUH and OLMC. No kidney recipients will be enrolled at UH because UH does not perform isolated kidney transplantation.
- All recipients of livers from deceased donors enrolled in this study and who receive their transplants at either of the two liver transplant centers in New Jersey, UH or OLMC.
- All recipients of solid organ pancreas (isolated pancreas transplant or combined kidney pancreas transplant) from deceased donors enrolled in this study and who receive their transplants at one of the four pancreas transplant centers in New Jersey, HUH, SBMC, RWJUH and OLMC. NBIMC and UH do not perform pancreas transplantation
Who cannot join
- Tissue only donors
- Age < 5 years
- When it is known before organ recovery that both kidneys will be leaving New Jersey. This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
- Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
- Severe trauma to both lower extremities precluding induction of RIPC
- RECIPIENTS - KIDNEY
Show all 22Show fewer
- All live donor kidney transplants performed at participating kidney transplant centers
- Recipients of deceased donor kidneys imported from outside NJTO
- Recipients of kidneys from deceased donors < 5 years of age
- Recipients of combined liver and kidney transplantation, which are performed only at UH and OLMC. The numbers of such transplants are very few per year (<5). Also, the clinical and pathophysiological issues are different from those requiring isolated kidney transplantation
- Recipients of en bloc (both kidneys together into one recipient) kidney transplantation from study donors. It is anticipated that such instances will be very few per year (<5)
- Recipients of kidneys from deceased donors not enrolled in the study due to logistical reasons.
- RECIPIENTS - LIVER
- Live donor recipients
- Recipients of livers imported from outside NJTO
- Recipients of deceased donor livers from donors < 5 years of age
- Recipients of livers from deceased donors not enrolled in the study due to logistical reasons
- RECIPIENTS - PANCREAS
- Islet cell transplant recipients
- Recipients of deceased donor whole organ pancreas imported from outside NJ
- Recipients of pancreas from deceased donors < 5 years of age
- Recipients of pancreata from deceased donors not enrolled in the study due to logistical reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Efficacy of Remote Ischemic Preconditioning in Improving Outcomes in Organ Transplantation
Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood flow to the lower extremity prior to organ recovery in deceased donors, improve short and long term outcomes after transplantation of kidneys, livers and pancreas? To test this hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before organ recovery. RIPC will be induced in the operating room after commencement of procurement surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of the organ recovery and organ preservation will be as per standard of practice. Recovered livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation and patient management after transplantation will be as per standard of practice.
Organ-specific function and cell injury parameters will be utilized to assess the early postoperative outcomes of individual organs and recipients. Long term outcomes will be assessed by graft and recipient survival.
Read the detailed description
Deceased organ donors and recipients of kidneys, livers and pancreata from the study donors comprise the study subjects.
- DONORS
- A. Inclusion Criteria All deceased organ donors aged > 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
I.B. Exclusion criteria
- Tissue only donors
- Age < 5 years
- When it is known before organ recovery that both kidneys will be leaving New JerseyIntervention: RIPC will be induced by inflation of a tourniquet around the upper thigh to 200 mm of Hg for a period of 10 minutes. After tourniquet deflation on one side, a similar procedure will be followed immediately on the opposite side. Thus, a total period of 20 minutes of lower extremity vascular occlusion will be utilized to induce RIPC. In instances of severe trauma to one lower extremity precluding tourniquet use, we will employ two cycles of 10 minutes of tourniquet occlusion in the non-traumatized lower extremity with 10 min of reperfusion in between. RIPC will be induced after commencement of procurement surgery but completed 30-45 min before circulatory arrest and initiation of organ perfusion. Additionally, liver biopsies (a wedge measuring 0.75 x 0.75 cm and a Tru-cut needle biopsy from the right lobe) are performed in as soon as the abdomen is opened. A wedge (1 x 0.3 cm) kidney biopsy is performed in all donors after kidney recovery but before packing the organs. All biopsies except kidney biopsies in donors aged < 50 years, are as per standard of care. The remainder of organ recovery, organ packaging and preservation are as per standard of practice. All kidneys recovered from donors classified as Extended Criteria Donors (donor age > 60 years or age 50-59 years with two of the following three criteria- cerebrovascular cause of death, a history of hypertension, terminal serum creatinine > 1.5 mg/dL) are routinely perfused ex-vivo in a pulsatile hypothermic perfusion apparatus until transplantation. . This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
- Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
- Severe trauma to both lower extremities precluding induction of RIPC
- Conditions
- Kidney Disease, Liver Disease, Pancreas Disease
- Being tested
- RIPC by Inflation of Pneumatic Tourniquet
- Keywords
- Remote ischemic preconditioning, deceased organ donors, ischemia reperfusion injury, Delayed graft function, Clinical outcomes in kidney transplant recipients, Clinical outcomes in liver transplant recipients, Clinical outcomes in pancreas transplant recipients
- Medical subject headings
- Kidney Diseases, Liver Diseases, Pancreatic Diseases, Reperfusion Injury, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPC by Inflation of Pneumatic TourniquetProcedure or surgery
Pneumatic tourniquets will be placed on both lower extremities in all deceased donor subjects. In the RIPC group the tourniquets will be inflated sequentially for 10 min each followed by deflation, approximately, 30-60 min prior to aortic crossclamping and organ perfusion.
| Study group | Role | What they receive |
|---|---|---|
| No RIPC Group | No intervention | This group is the control group or the comparator group with RIPC |
| RIPC Group | Experimental | In this group deceased donors will receive Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet of the lower limb prior to organ recovery. Receives: Procedure: RIPC by Inflation of Pneumatic Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ Recovery
Organs Recovered and Transplanted per donor
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baburao Koneru, M.D., Principal investigator, UMDNJ-New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975702
- Sponsor's protocol ID
- 0120080212
- Acronym
- RIPCOT
- Status last verified
- Jan 2015
- First submitted
- 10 Sep 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.
PubMed 17846333Kanoria S, Jalan R, Seifalian AM, Williams R, Davidson BR. Protocols and mechanisms for remote ischemic preconditioning: a novel method for reducing ischemia reperfusion injury. Transplantation. 2007 Aug 27;84(4):445-58. doi: 10.1097/01.tp.0000228235.55419.e8.
PubMed 17713425Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
PubMed 16750696Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.
PubMed 19188504Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PubMed 17707752
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Efficacy of Remote Ischemic Preconditioning in Improving Outcomes in Organ Transplantation
- ClinicalTrials.gov ID
- NCT00975702
- Acronym / sponsor ID
- RIPCOT / 0120080212
- Conditions
- Kidney Disease, Liver Disease, Pancreas Disease
- Keywords
- Remote ischemic preconditioning, deceased organ donors, ischemia reperfusion injury, Delayed graft function, Clinical outcomes in kidney transplant recipients, Clinical outcomes in liver transplant recipients, Clinical outcomes in pancreas transplant recipients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood flow to the lower extremity prior to organ recovery in deceased donors, improve short and long term outcomes after transplantation of kidneys, livers and pancreas? To test this hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before organ recovery. RIPC will be induced in the operating room after commencement of procurement surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of the organ recovery and organ preservation will be as per standard of practice. Recovered livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation and patient management after transplantation will be as per standard of practice.
Organ-specific function and cell injury parameters will be utilized to assess the early postoperative outcomes of individual organs and recipients. Long term outcomes will be assessed by graft and recipient survival.
Detailed description
Deceased organ donors and recipients of kidneys, livers and pancreata from the study donors comprise the study subjects.
- DONORS
- A. Inclusion Criteria All deceased organ donors aged > 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
I.B. Exclusion criteria
- Tissue only donors
- Age < 5 years
- When it is known before organ recovery that both kidneys will be leaving New JerseyIntervention: RIPC will be induced by inflation of a tourniquet around the upper thigh to 200 mm of Hg for a period of 10 minutes. After tourniquet deflation on one side, a similar procedure will be followed immediately on the opposite side. Thus, a total period of 20 minutes of lower extremity vascular occlusion will be utilized to induce RIPC. In instances of severe trauma to one lower extremity precluding tourniquet use, we will employ two cycles of 10 minutes of tourniquet occlusion in the non-traumatized lower extremity with 10 min of reperfusion in between. RIPC will be induced after commencement of procurement surgery but completed 30-45 min before circulatory arrest and initiation of organ perfusion. Additionally, liver biopsies (a wedge measuring 0.75 x 0.75 cm and a Tru-cut needle biopsy from the right lobe) are performed in as soon as the abdomen is opened. A wedge (1 x 0.3 cm) kidney biopsy is performed in all donors after kidney recovery but before packing the organs. All biopsies except kidney biopsies in donors aged < 50 years, are as per standard of care. The remainder of organ recovery, organ packaging and preservation are as per standard of practice. All kidneys recovered from donors classified as Extended Criteria Donors (donor age > 60 years or age 50-59 years with two of the following three criteria- cerebrovascular cause of death, a history of hypertension, terminal serum creatinine > 1.5 mg/dL) are routinely perfused ex-vivo in a pulsatile hypothermic perfusion apparatus until transplantation. . This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
- Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
- Severe trauma to both lower extremities precluding induction of RIPC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No RIPC Group | No intervention | –This group is the control group or the comparator group with RIPC |
| RIPC Group | Experimental | Procedure: RIPC by Inflation of Pneumatic TourniquetIn this group deceased donors will receive Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet of the lower limb prior to organ recovery. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All deceased organ donors aged > 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
- DONORS
- Patients who receive a kidney from an enrolled donor at one of the five kidney transplant centers in New Jersey, HUH, NBIMC, SBMC, RWJUH and OLMC. No kidney recipients will be enrolled at UH because UH does not perform isolated kidney transplantation.
- All recipients of livers from deceased donors enrolled in this study and who receive their transplants at either of the two liver transplant centers in New Jersey, UH or OLMC.
- All recipients of solid organ pancreas (isolated pancreas transplant or combined kidney pancreas transplant) from deceased donors enrolled in this study and who receive their transplants at one of the four pancreas transplant centers in New Jersey, HUH, SBMC, RWJUH and OLMC. NBIMC and UH do not perform pancreas transplantation
Key exclusion criteria (22 listed)
- Tissue only donors
- Age < 5 years
- When it is known before organ recovery that both kidneys will be leaving New Jersey. This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
- Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
- Severe trauma to both lower extremities precluding induction of RIPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPC by Inflation of Pneumatic TourniquetPneumatic tourniquets will be placed on both lower extremities in all deceased donor subjects. In the RIPC group the tourniquets will be inflated sequentially for 10 min each followed by deflation, approximately, 30-60 min prior to aortic crossclamping and organ perfusion. | Procedure or surgery | RIPC Group |
Primary outcome
Organ Recovery
Time frame: 1 week
Organs Recovered and Transplanted per donor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Background: PubMed 17846333Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. doi: 10.1161/circulationaha.106.679167.
- Background: PubMed 17713425Kanoria S, Jalan R, Seifalian AM, Williams R, Davidson BR. Protocols and mechanisms for remote ischemic preconditioning: a novel method for reducing ischemia reperfusion injury. Transplantation. 2007 Aug 27;84(4):445-58. doi: 10.1097/01.tp.0000228235.55419.e8.
- Background: PubMed 16750696Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
- Background: PubMed 19188504Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.
- Background: PubMed 17707752Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baburao Koneru, M.D. principal investigator
UMDNJ-New Jersey Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RIPC by Inflation of Pneumatic Tourniquet in people with Kidney Disease and Liver Disease, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ Recovery (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975702, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.