Liver FailureNCT02635347
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
A study testing Remote Ischemic Conditioning (RIC) and Pneumatic tourniquet in people with Liver Failure and Carcinoma, Hepatocellular, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Carcinoma, Hepatocellular
- What is being tested?
- Remote Ischemic Conditioning (RIC) and Pneumatic tourniquet
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years of age) with acute and chronic liver failure requiring liver transplants or patients undergoing transplantation for hepatocellular carcinoma.
- Both sexes
- Written consent to participate in the study
Who cannot join
- < 18 years of age
- Recipients of split livers
- Retransplantation
- Recipients of livers combined with other organs
- Recipients of livers from cardiac death donors
- Lower extremity amputees
Show all 13Show fewer
- History of peripheral vascular disease
- Patients taking sulfonylurea anti-diabetic agents at the time of transplant
- Patients taking nitrates at the time of transplant
- Body mass index > 45
- Pregnant patients
- Patients in whom complete lower extremity ischemia is not achieved despite maximum tourniquet inflation to 250 mmHg during the first intervention
- Patients with lower extremity paralysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University - University Hospital
Newark, New Jersey, 07101-0820
About this study
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of reperfusion. Interventions will take place after anesthesia induction but before surgery, at the completion of the procedure, and on the mornings of post-operative days 1-4.
Read the detailed description
Orthotopic liver transplantation (OLT) is associated with a very high risk of complications. In a recent multi-center study of 450 patients, 79% had at least one complication and 63% had severe (Clavien-Dindo grade III or higher) complications. The number and severity of complications are associated with death within 30 days, hospital length of stay, graft and patient survival. Infections are the most common group of complications, followed by pulmonary, renal and liver graft dysfunction. Interventions that decrease these complications after OLT are likely to improve clinical outcomes.
Remote ischemic conditioning is an innate biological phenomenon wherein a brief single or repetitive ischemic stimulus in an organ or tissue such as skeletal muscle induce protection in remote/distant organs against ischemia and other noxious stimuli. This effect can be induced by inflating a pneumatic tourniquet on a leg or arm for a few minutes (usually 5-10) and subsequently deflating to allow reperfusion. This process is usually repeated 3-4 times to ensure an adequate dose of the conditioning stimulus. The conditioning stimulus could be applied before (Preconditioning), concurrent with (Perconditioning), or soon after the index noxious/ischemic insult (Postconditioning).
The goal of this study is to assess the feasibility, patient acceptance, and safety of RIC in liver recipients. In addition, the investigators will obtain data on posttransplant complications. Information obtained from this study will help guide the design of a future randomized, controlled trial to test the benefit of RIC in liver recipients.
- Conditions
- Liver Failure, Carcinoma, Hepatocellular
- Being tested
- Remote Ischemic Conditioning (RIC), Pneumatic tourniquet
- Keywords
- Remote ischemic preconditioning, Remote ischemic perconditioning, Remote ischemic postconditioning, Remote ischemic conditioning, Orthotopic liver transplant, Brain Death Organ Donor
- Medical subject headings
- Liver Failure, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning (RIC)Procedure or surgery
Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.
Pneumatic tourniquetDevice
Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning (RIC) group | Experimental | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Receives: Procedure: Remote Ischemic Conditioning (RIC); Device: Pneumatic tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing Entire Intervention Protocol
Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions.
Measured: Pre-op - Post-op day 4
Secondary outcomes (13)
Intervention-related Pain Score
Median intervention-related pain score during each of the post-operative interventions, in extubated patients who are able to communicate. Using the Numerical Rating Scale (NRS, Ferrieira-Valente MA PAIN Volume 152, 2011), patients were asked to rate their pain following the intervention on a scale of 0-10 with 0 being no pain experienced to 10 as the maximum pain felt.
Measured: Post-op days 1-4
Withdrawal of Consent Due to Pain
- Withdrawal of consent due to discomfort/pain in the lower extremity
Measured: Pre-op - Post-op day 7
Percentage of Participants Who Developed Early Allograft Dysfunction (EAD)
Percentage of participants who developed Early Allograft Dysfunction (EAD) which is defined as:
- Aspartate Transaminase (AST) or Alanine Transaminase (ALT)> 2,000 U/L at any point within the first seven post-transplant days, or
- Total Bilirubin (TB) > 10 mg/dL on postoperative day 7,or
- International Normalized Ratio (INR)> 1.6 on postoperative day 7.
Measured: Post-op days 0-7
Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI)
Percentage of Participants who developed Prolonged Respiratory Insufficiency (PRI) defined as:
- Ventilator support for >2 postoperative days after transplant, or
- Reintubation after extubation, within 7 days of transplant. Patients who require brief re-intubation for an endoscopic, radiologic, or surgical procedure would not be considered to have PRI if they are extubated within 2 days of the end of the procedure.
Measured: Post-op days 0-7
Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3
Percentage of participants who developed Acute Kidney Injury (AKI)
Based on Kidney Disease - Improving Global Outcomes (KDIGO) criteria, AKI criteria are:
Stage 2:
- 2.0-2.9 fold rise in serum creatinine from baseline
Stage 3:
- > 3.0 fold rise in serum creatinine from baseline, or
- Serum creatinine of > 4.0 mg/dL, with an acute (<48 hours) increase of 0.3 mg/dL in serum creatinine or subacute (< 7 days) increase in serum creatinine of 0.5 mg/dL, or
- Initiation of renal replacement therapy.
Measured: Post-op days 0-7
Time to Dialysis Discontinuation
In patients who are receiving dialysis pre-op, time to discontinuation of dialysis, if occurring within 90 days of transplantation.
Measured: Post-op days 0-90
Presence of Clavien-Dindo Grade IIIb or Higher Complications
Percentage of patients with Clavien-Dindo >/= grade III b complications (Dindo D, Demartines N, Clavien P, Annals of Surgery 2004).
The Clavien-Dindo Complications grade ranges from Grade I (Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside) to Grade V (Death). Grade IIIb would be any intervention requiring general anesthesia.
Measured: Post-op days 0-30
Clavien-Dindo Grade IIIb or Higher - Number of Complications
In patients with Clavien-Dindo >/= IIIb complications, number of such complications per patient.
Measured: Post-op days 0-30
Intensive Care Unit (ICU) Length of Stay (LOS)
Number of days in ICU post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is transferred out of ICU, dies, or post-op day 90, whichever is soonest.
Measured: Post-op days 0 up to 90 days
Hospital LOS
Number of days in hospital post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is leaves the hospital, dies, or post-op day 90, whichever is soonest.
Measured: Post-op days 0 up to 90 days
Liver Allograft Survival
Percentage of patients with functioning allograft at 90 days post-transplant
Measured: Post-op day 90
Patient Survival
Percentage of patients alive at 90 days post-transplant
Measured: Post-op day 90
Number of Subjects Not Completing Intervention Protocol
Number of subjects that received fewer than 6 interventions,.
Measured: Pre-op - Post-op day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baburao Koneru, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Baburao Koneru, MD, MPH, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635347
- Sponsor's protocol ID
- Pro20150002276
- Status last verified
- Jul 2019
- First submitted
- 6 Dec 2015
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Parikh A, Washburn KW, Matsuoka L, Pandit U, Kim JE, Almeda J, Mora-Esteves C, Halff G, Genyk Y, Holland B, Wilson DJ, Sher L, Koneru B. A multicenter study of 30 days complications after deceased donor liver transplantation in the model for end-stage liver disease score era. Liver Transpl. 2015 Sep;21(9):1160-8. doi: 10.1002/lt.24181.
PubMed 25991395Huang CT, Lin HC, Chang SC, Lee WC. Pre-operative risk factors predict post-operative respiratory failure after liver transplantation. PLoS One. 2011;6(8):e22689. doi: 10.1371/journal.pone.0022689. Epub 2011 Aug 1.
PubMed 21829646Levesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. doi: 10.1097/TP.0b013e31825c1d41.
PubMed 22885879Gracey DR, Divertie MB, Didier EP. Preoperative pulmonary preparation of patients with chronic obstructive pulmonary disease: a prospective study. Chest. 1979 Aug;76(2):123-9. doi: 10.1378/chest.76.2.123.
PubMed 456049Svensson LG, Hess KR, Coselli JS, Safi HJ, Crawford ES. A prospective study of respiratory failure after high-risk surgery on the thoracoabdominal aorta. J Vasc Surg. 1991 Sep;14(3):271-82.
PubMed 1880835Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000 Aug;232(2):242-53. doi: 10.1097/00000658-200008000-00015.
PubMed 10903604Hilmi IA, Damian D, Al-Khafaji A, Planinsic R, Boucek C, Sakai T, Chang CC, Kellum JA. Acute kidney injury following orthotopic liver transplantation: incidence, risk factors, and effects on patient and graft outcomes. Br J Anaesth. 2015 Jun;114(6):919-26. doi: 10.1093/bja/aeu556. Epub 2015 Feb 10.
PubMed 25673576Salvalaggio PR, Felga GE, Afonso RC, Ferraz-Neto BH. Early allograft dysfunction and liver transplant outcomes: a single center retrospective study. Transplant Proc. 2012 Oct;44(8):2449-51. doi: 10.1016/j.transproceed.2012.08.002.
PubMed 23026617Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
PubMed 20677285Tapuria N, Kumar Y, Habib MM, Abu Amara M, Seifalian AM, Davidson BR. Remote ischemic preconditioning: a novel protective method from ischemia reperfusion injury--a review. J Surg Res. 2008 Dec;150(2):304-30. doi: 10.1016/j.jss.2007.12.747. Epub 2008 Jan 22.
PubMed 19040966Przyklenk K, Whittaker P. Genesis of remote conditioning: action at a distance--'hypotheses non fingo'? J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):180-6. doi: 10.2459/JCM.0b013e328358c8eb.
PubMed 22964648McCafferty K, Forbes S, Thiemermann C, Yaqoob MM. The challenge of translating ischemic conditioning from animal models to humans: the role of comorbidities. Dis Model Mech. 2014 Dec;7(12):1321-33. doi: 10.1242/dmm.016741.
PubMed 25481012Ali 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 17846333Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
PubMed 26024502Kottenberg E, Thielmann M, Bergmann L, Heine T, Jakob H, Heusch G, Peters J. Protection by remote ischemic preconditioning during coronary artery bypass graft surgery with isoflurane but not propofol - a clinical trial. Acta Anaesthesiol Scand. 2012 Jan;56(1):30-8. doi: 10.1111/j.1399-6576.2011.02585.x. Epub 2011 Nov 21.
PubMed 22103808
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT02635347
- Acronym / sponsor ID
- Pro20150002276
- Conditions
- Liver Failure, Carcinoma, Hepatocellular
- Keywords
- Remote ischemic preconditioning, Remote ischemic perconditioning, Remote ischemic postconditioning, Remote ischemic conditioning, Orthotopic liver transplant, Brain Death Organ Donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of reperfusion. Interventions will take place after anesthesia induction but before surgery, at the completion of the procedure, and on the mornings of post-operative days 1-4.
Detailed description
Orthotopic liver transplantation (OLT) is associated with a very high risk of complications. In a recent multi-center study of 450 patients, 79% had at least one complication and 63% had severe (Clavien-Dindo grade III or higher) complications. The number and severity of complications are associated with death within 30 days, hospital length of stay, graft and patient survival. Infections are the most common group of complications, followed by pulmonary, renal and liver graft dysfunction. Interventions that decrease these complications after OLT are likely to improve clinical outcomes.
Remote ischemic conditioning is an innate biological phenomenon wherein a brief single or repetitive ischemic stimulus in an organ or tissue such as skeletal muscle induce protection in remote/distant organs against ischemia and other noxious stimuli. This effect can be induced by inflating a pneumatic tourniquet on a leg or arm for a few minutes (usually 5-10) and subsequently deflating to allow reperfusion. This process is usually repeated 3-4 times to ensure an adequate dose of the conditioning stimulus. The conditioning stimulus could be applied before (Preconditioning), concurrent with (Perconditioning), or soon after the index noxious/ischemic insult (Postconditioning).
The goal of this study is to assess the feasibility, patient acceptance, and safety of RIC in liver recipients. In addition, the investigators will obtain data on posttransplant complications. Information obtained from this study will help guide the design of a future randomized, controlled trial to test the benefit of RIC in liver recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning (RIC) group | Experimental | Procedure: Remote Ischemic Conditioning (RIC), Device: Pneumatic tourniquetParticipants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (> 18 years of age) with acute and chronic liver failure requiring liver transplants or patients undergoing transplantation for hepatocellular carcinoma.
- Both sexes
- Written consent to participate in the study
Key exclusion criteria (13 listed)
- < 18 years of age
- Recipients of split livers
- Retransplantation
- Recipients of livers combined with other organs
- Recipients of livers from cardiac death donors
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 |
|---|---|---|
| Remote Ischemic Conditioning (RIC)Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. | Procedure or surgery | Remote Ischemic Conditioning (RIC) group |
| Pneumatic tourniquetPortable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | Device | Remote Ischemic Conditioning (RIC) group |
Primary outcome
Percentage of Participants Completing Entire Intervention Protocol
Time frame: Pre-op - Post-op day 4
Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions.
13 secondary outcomes
Intervention-related Pain Score
Time frame: Post-op days 1-4
Withdrawal of Consent Due to Pain
Time frame: Pre-op - Post-op day 7
Percentage of Participants Who Developed Early Allograft Dysfunction (EAD)
Time frame: Post-op days 0-7
Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI)
Time frame: Post-op days 0-7
Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3
Time frame: Post-op days 0-7
Time to Dialysis Discontinuation
Time frame: Post-op days 0-90
Presence of Clavien-Dindo Grade IIIb or Higher Complications
Time frame: Post-op days 0-30
Clavien-Dindo Grade IIIb or Higher - Number of Complications
Time frame: Post-op days 0-30
Intensive Care Unit (ICU) Length of Stay (LOS)
Time frame: Post-op days 0 up to 90 days
Hospital LOS
Time frame: Post-op days 0 up to 90 days
Liver Allograft Survival
Time frame: Post-op day 90
Patient Survival
Time frame: Post-op day 90
Number of Subjects Not Completing Intervention Protocol
Time frame: Pre-op - Post-op day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25991395Parikh A, Washburn KW, Matsuoka L, Pandit U, Kim JE, Almeda J, Mora-Esteves C, Halff G, Genyk Y, Holland B, Wilson DJ, Sher L, Koneru B. A multicenter study of 30 days complications after deceased donor liver transplantation in the model for end-stage liver disease score era. Liver Transpl. 2015 Sep;21(9):1160-8. doi: 10.1002/lt.24181.
- Background: PubMed 21829646Huang CT, Lin HC, Chang SC, Lee WC. Pre-operative risk factors predict post-operative respiratory failure after liver transplantation. PLoS One. 2011;6(8):e22689. doi: 10.1371/journal.pone.0022689. Epub 2011 Aug 1.
- Background: PubMed 22885879Levesque E, Hoti E, Azoulay D, Honore I, Guignard B, Vibert E, Ichai P, Antoun F, Saliba F, Samuel D. Pulmonary complications after elective liver transplantation-incidence, risk factors, and outcome. Transplantation. 2012 Sep 15;94(5):532-8. doi: 10.1097/TP.0b013e31825c1d41.
- Background: PubMed 456049Gracey DR, Divertie MB, Didier EP. Preoperative pulmonary preparation of patients with chronic obstructive pulmonary disease: a prospective study. Chest. 1979 Aug;76(2):123-9. doi: 10.1378/chest.76.2.123.
- Background: PubMed 1880835Svensson LG, Hess KR, Coselli JS, Safi HJ, Crawford ES. A prospective study of respiratory failure after high-risk surgery on the thoracoabdominal aorta. J Vasc Surg. 1991 Sep;14(3):271-82.
- Background: PubMed 10903604Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000 Aug;232(2):242-53. doi: 10.1097/00000658-200008000-00015.
- Background: PubMed 25673576Hilmi IA, Damian D, Al-Khafaji A, Planinsic R, Boucek C, Sakai T, Chang CC, Kellum JA. Acute kidney injury following orthotopic liver transplantation: incidence, risk factors, and effects on patient and graft outcomes. Br J Anaesth. 2015 Jun;114(6):919-26. doi: 10.1093/bja/aeu556. Epub 2015 Feb 10.
- Background: PubMed 23026617Salvalaggio PR, Felga GE, Afonso RC, Ferraz-Neto BH. Early allograft dysfunction and liver transplant outcomes: a single center retrospective study. Transplant Proc. 2012 Oct;44(8):2449-51. doi: 10.1016/j.transproceed.2012.08.002.
- Background: PubMed 20677285Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
- Background: PubMed 19040966Tapuria N, Kumar Y, Habib MM, Abu Amara M, Seifalian AM, Davidson BR. Remote ischemic preconditioning: a novel protective method from ischemia reperfusion injury--a review. J Surg Res. 2008 Dec;150(2):304-30. doi: 10.1016/j.jss.2007.12.747. Epub 2008 Jan 22.
- Background: PubMed 22964648Przyklenk K, Whittaker P. Genesis of remote conditioning: action at a distance--'hypotheses non fingo'? J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):180-6. doi: 10.2459/JCM.0b013e328358c8eb.
- Background: PubMed 25481012McCafferty K, Forbes S, Thiemermann C, Yaqoob MM. The challenge of translating ischemic conditioning from animal models to humans: the role of comorbidities. Dis Model Mech. 2014 Dec;7(12):1321-33. doi: 10.1242/dmm.016741.
- Individual participant dataSharing planned: No
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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, MD, MPH principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning (RIC) and Pneumatic tourniquet in people with Liver Failure and Carcinoma, Hepatocellular, run by Rutgers, The State University 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 3 inclusion and 13 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 20 Aug 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Completing Entire Intervention Protocol (time frame: Pre-op - Post-op day 4). 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 NCT02635347, which also lists 25 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 20 Aug 2019.