LaparotomyNCT03234543

Remote Ischemic Conditioning in Abdominal Surgery

A study testing Remote ischemic conditioning and No Remote ischemic conditioning in people with Laparotomy and Laparoscopy, run by Rutgers, The State University of New Jersey at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Laparotomy, Laparoscopy, Retroperitoneal Disease
What is being tested?: Remote ischemic conditioning and No Remote ischemic conditioning
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 8 Oct 2017to 15 Jun 2020
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults (> 18 years of age)
Both genders
Undergoing major abdominal surgery as above
Elective surgeries
Both outpatients and in-hospital patients
Post-op length of stay expected to be at least 2 days by the primary surgical service

Who cannot join

Subjects with lower extremity paralysis
Lower extremity amputees
Known, documented peripheral arterial disease
Body mass index > 45
Pregnancy
Trauma patients

Show all 12Show fewer

Organ transplant recipients
Prior major surgery during current hospitalization (for instance, a patient undergoing re-laparotomy for a complication from a previous procedure)
Patient taking sulfonylureas or nitrates prior to or during admission (listed in Appendix B)
These subjects are excluded because sulfonylureas are shown to abrogate the RIC effect whereas nitrates are shown to mimic the RIC effect in animal models.
Non-elective surgeries (urgent or emergent surgeries)
General surgical procedures with no planned intra-abdominal component

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospital
Newark, New Jersey, 07101

Other trials in United States

About this study

Official title: Remote Ischemic Conditioning (RIC) to Decrease Post-Operative Complications After Major Abdominal Surgery - A Phase IIa Trial

This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be enrolled at a single institution - University Hospital - Newark. The study population are patients undergoing major abdominal surgery (anticipated to be >/= 2 hrs long with a hospital stay >/= 2 days). Subjects in the treatment group will receive lower limb ischemic conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in systemic inflammatory markers in peripheral blood and 30-day mortality.

Read the detailed description

STUDY GOALS AND OBJECTIVES:

To obtain preliminary data regarding postoperative complications in subjects undergoing abdominal surgery and receiving remote limb ischemic or sham conditioning.
To test whether remote limb ischemic conditioning (RIC) decreases systemic inflammatory response in patients undergoing major abdominal surgery.

HYPOTHESiS:

The central hypothesis of the research is that pre- and post-operative RIC in patients undergoing major abdominal surgery would decrease the systemic inflammatory response to major abdominal surgery and decrease postoperative complications.

STUDY DESIGN:

A prospective, randomized, double - masked clinical trial of RIC will be conducted in adult patients undergoing major abdominal surgery at University Hospital in Newark, NJ. Participants will be randomized into two groups: RIC and No RIC. RIC will be induced at three time points - the first after anesthesia induction but before commencement of surgery, and the second and the third on post-operative days 1 and 2, respectively. The RIC intervention consists of 5 minutes of inflation of a pneumatic tourniquet placed mid-thigh followed by 5 minutes of deflation, repeated for 3 cycles. The pressure used will be 250 mmHg for the pre-operative intervention. Subsequent tourniquet pressures will be 50 mmHg above the patient's systolic blood pressure. The No RIC group will receive a sham intervention at all the same time points. The thigh tourniquet will be inflated to only 20 mmHg. A Doppler probe will be used to assess pedal arterial flow in both groups. Blood samples will be collected at baseline, 1hr after skin closure, and 1hr after interventions 2 and 3.

STUDY POPULATION:

Adults (> 18 years of age) of both sexes scheduled for elective major abdominal surgery at University Hospital will be considered for inclusion. Major abdominal surgery is defined as peritoneal, retroperitoneal and pelvic surgery expected to last >/= 120 minutes (from incision to closure) with an expected hospital stay >/= 2 days. A list of surgeries considered for inclusion is included as Appendix A. Additional operations will be considered for inclusion if the study team and primary surgical team both agree that the procedure is a major abdominal surgery and that the duration of surgery is likely to be > 2 hours.

RISKS AND BENEFITS

Risks to Subjects During inflation of the tourniquet in awake patients (post-op), there is a risk of pain secondary to tourniquet inflation. The investigators believe this risk is small, and if it occurs, the patient will have the option to discontinue the intervention. There is a theoretical risk of injury to the limb receiving the RIC stimulus. However, such occurrences have not been reported to date in other clinical studies. During collection of blood samples, there is a theoretical risk of bleeding from the venipuncture site; however this risk is no greater than routine blood draw. The amount of blood drawn for study purposes will be small (less than 50 mL total anticipated).
Benefits to Subjects The anticipated benefit to subjects is fewer complications after major abdominal surgery. However, no such benefit may accrue. In addition, the study is expected to provide valuable information regarding how RIC might modulate stress response to major surgery.

Conditions: Laparotomy, Laparoscopy, Retroperitoneal Disease, Pelvis Disease, Pancreatic Diseases, Liver Diseases
Being tested: Remote ischemic conditioning, No Remote ischemic conditioning
Keywords: Abdominal Surgery, Pre-conditioning, Remote Ischemic Conditioning, Post-Operative Complications, Acute Phase Response
Medical subject headings: Pancreatic Diseases, Liver Diseases, Gastrointestinal Diseases, Urologic Diseases, Acute-Phase Reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote ischemic conditioningProcedure or surgery
Placement of blood pressure cuff to lower extremity in order to induce temporary and reversible ischemia.
No Remote ischemic conditioningProcedure or surgery
Placement of blood pressure cuff to lower extremity with minimal inflation without inducing ischemia.

Study groups in NCT03234543
Study group	Role	What they receive
Remote Ischemic Conditioning	Experimental	The RIC intervention consists of 5 minutes of inflation of a pneumatic tourniquet placed mid-thigh followed by 5 minutes of deflation, repeated for 3 cycles. The pressure used will be 250 mmHg for the pre-operative intervention. Subsequent tourniquet pressures will be 50 mmHg above the patient's systolic blood pressure. Receives: Procedure: Remote ischemic conditioning
No Remote Ischemic Conditioning	Sham comparator	The No RIC group will receive a sham intervention at all the same time points. The thigh tourniquet will be inflated to only 20 mmHg (to mask the intervention from the subject). Receives: Procedure: No Remote ischemic conditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

Comprehensive Complication Index
The CCI, a validated and scaled score of all surgical complications (range 0 [no complications] to 100 [death]) will be computed for each subject using the publically available website, http://www.assessurgery.com/.
Measured: 30 days after surgery

Secondary outcomes (7)

Completion all three interventions
Proportions of subjects completing all three research interventions
Measured: Up to 3 days
Hospital days
Number of days to discharge from the hospital after surgery
Measured: Up to 30 days
30-day mortality
Proportions of patients dying within 30 days after surgery
Measured: Up to 30 days
Plasma complement levels (C2, C4b, C5, C5a, and C5b-9)
Measured at baseline, an hour after skin closure, completion of second and third research intervention
Measured: Up to 3 days
Plasma cytokines levels (TNF-a, IL - 1, 6, 8 and 10)
Plasma cytokine levels at baseline, an hour after skin closure, completion of second and third research intervention
Measured: Up to 3 days
Plasma acute phase reactant proteins (CRP, alpha-1- acid glycoprotein, FGN, and haptoglobin)
Measured at baseline, an hour after skin closure, completion of second and third research intervention
Measured: Up to 3 days
Peripheral blood leukocyte gene expression profiles determined by RNA sequencing.
Measured at baseline, an hour after skin closure, completion of second and third research intervention
Measured: Up to 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 201715 Jun 2020

First posted31 Jul 2017
Study start8 Oct 2017
Primary completion15 Jun 2019 (estimated)
Study completion15 Jun 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for LaparotomyStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A prospective, randomized, double - masked clinical trial of RIC will be conducted in adult patients undergoing major abdominal surgery at University Hospital in Newark, NJ. Participants will be randomized into two groups: RIC and No RIC.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03234543
Sponsor's protocol ID: Pro20160001420
Status last verified: Feb 2019
First submitted: 25 Jul 2017
Last updated: 25 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
PubMed 23728278
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Lausevic Z, Lausevic M, Trbojevic-Stankovic J, Krstic S, Stojimirovic B. Predicting multiple organ failure in patients with severe trauma. Can J Surg. 2008 Apr;51(2):97-102.
PubMed 18377749
Kvarnstrom AL, Sarbinowski RT, Bengtson JP, Jacobsson LM, Bengtsson AL. Complement activation and interleukin response in major abdominal surgery. Scand J Immunol. 2012 May;75(5):510-6. doi: 10.1111/j.1365-3083.2012.02672.x.
PubMed 22229650
Kvarnstrom A, Sokolov A, Swartling T, Kurlberg G, Mollnes TE, Bengtsson A. Alternative pathway activation of complement in laparoscopic and open rectal surgery. Scand J Immunol. 2012 Jul;76(1):49-53. doi: 10.1111/j.1365-3083.2012.02702.x.
PubMed 22486843
Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641.
PubMed 9315559
Leung CH, Caldarone CA, Wang F, Venkateswaran S, Ailenberg M, Vadasz B, Wen XY, Rotstein OD. Remote Ischemic Conditioning Prevents Lung and Liver Injury After Hemorrhagic Shock/Resuscitation: Potential Role of a Humoral Plasma Factor. Ann Surg. 2015 Jun;261(6):1215-25. doi: 10.1097/SLA.0000000000000877.
PubMed 25185480
Konstantinov IE, Arab S, Kharbanda RK, Li J, Cheung MM, Cherepanov V, Downey GP, Liu PP, Cukerman E, Coles JG, Redington AN. The remote ischemic preconditioning stimulus modifies inflammatory gene expression in humans. Physiol Genomics. 2004 Sep 16;19(1):143-50. doi: 10.1152/physiolgenomics.00046.2004. Epub 2004 Aug 10.
PubMed 15304621
Pang T, Zhao Y, Zhang NR, Jin SQ, Pan SQ. Transient limb ischemia alters serum protein expression in healthy volunteers: complement C3 and vitronectin may be involved in organ protection induced by remote ischemic preconditioning. Oxid Med Cell Longev. 2013;2013:859056. doi: 10.1155/2013/859056. Epub 2013 Dec 2.
PubMed 24363825
Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
PubMed 18456674
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 17846333
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
PubMed 23035060
Zarbock 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 26024502
Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schon J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.
PubMed 26436208
Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, Knight R, Kunst G, Laing C, Nicholas J, Pepper J, Robertson S, Xenou M, Clayton T, Yellon DM; ERICCA Trial Investigators. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery. N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.
PubMed 26436207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remote Ischemic Conditioning (RIC) to Decrease Post-Operative Complications After Major Abdominal Surgery - A Phase IIa Trial
ClinicalTrials.gov ID: NCT03234543
Acronym / sponsor ID: Pro20160001420
Conditions: Laparotomy, Laparoscopy, Retroperitoneal Disease, Pelvis Disease, Pancreatic Diseases, Liver Diseases
Keywords: Abdominal Surgery, Pre-conditioning, Remote Ischemic Conditioning, Post-Operative Complications, Acute Phase Response
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Study start: 8 Oct 2017 (actual)
Primary completion: 15 Jun 2019 (estimated)
Study completion: 15 Jun 2020 (estimated)
First posted: 31 Jul 2017 (actual)
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.

Detailed description

STUDY GOALS AND OBJECTIVES:

To obtain preliminary data regarding postoperative complications in subjects undergoing abdominal surgery and receiving remote limb ischemic or sham conditioning.
To test whether remote limb ischemic conditioning (RIC) decreases systemic inflammatory response in patients undergoing major abdominal surgery.

HYPOTHESiS:

STUDY DESIGN:

STUDY POPULATION:

RISKS AND BENEFITS

Risks to Subjects During inflation of the tourniquet in awake patients (post-op), there is a risk of pain secondary to tourniquet inflation. The investigators believe this risk is small, and if it occurs, the patient will have the option to discontinue the intervention. There is a theoretical risk of injury to the limb receiving the RIC stimulus. However, such occurrences have not been reported to date in other clinical studies. During collection of blood samples, there is a theoretical risk of bleeding from the venipuncture site; however this risk is no greater than routine blood draw. The amount of blood drawn for study purposes will be small (less than 50 mL total anticipated).
Benefits to Subjects The anticipated benefit to subjects is fewer complications after major abdominal surgery. However, no such benefit may accrue. In addition, the study is expected to provide valuable information regarding how RIC might modulate stress response to major surgery.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: A prospective, randomized, double - masked clinical trial of RIC will be conducted in adult patients undergoing major abdominal surgery at University Hospital in Newark, NJ. Participants will be randomized into two groups: RIC and No RIC.

Arm	Type	Receives
Remote Ischemic Conditioning	Experimental	Procedure: Remote ischemic conditioningThe RIC intervention consists of 5 minutes of inflation of a pneumatic tourniquet placed mid-thigh followed by 5 minutes of deflation, repeated for 3 cycles. The pressure used will be 250 mmHg for the pre-operative intervention. Subsequent tourniquet pressures will be 50 mmHg above the patient's systolic blood pressure.
No Remote Ischemic Conditioning	Sham comparator	Procedure: No Remote ischemic conditioningThe No RIC group will receive a sham intervention at all the same time points. The thigh tourniquet will be inflated to only 20 mmHg (to mask the intervention from the subject).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adults (> 18 years of age)
Both genders
Undergoing major abdominal surgery as above
Elective surgeries
Both outpatients and in-hospital patients

Key exclusion criteria (12 listed)

Subjects with lower extremity paralysis
Lower extremity amputees
Known, documented peripheral arterial disease
Body mass index > 45
Pregnancy

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 conditioningPlacement of blood pressure cuff to lower extremity in order to induce temporary and reversible ischemia.	Procedure or surgery	Remote Ischemic Conditioning
No Remote ischemic conditioningPlacement of blood pressure cuff to lower extremity with minimal inflation without inducing ischemia.	Procedure or surgery	No Remote Ischemic Conditioning

Primary outcome

Comprehensive Complication Index
Time frame: 30 days after surgery
The CCI, a validated and scaled score of all surgical complications (range 0 [no complications] to 100 [death]) will be computed for each subject using the publically available website, http://www.assessurgery.com/.

7 secondary outcomes

Completion all three interventions
Time frame: Up to 3 days
Hospital days
Time frame: Up to 30 days
30-day mortality
Time frame: Up to 30 days
Plasma complement levels (C2, C4b, C5, C5a, and C5b-9)
Time frame: Up to 3 days
Plasma cytokines levels (TNF-a, IL - 1, 6, 8 and 10)
Time frame: Up to 3 days
Plasma acute phase reactant proteins (CRP, alpha-1- acid glycoprotein, FGN, and haptoglobin)
Time frame: Up to 3 days
Peripheral blood leukocyte gene expression profiles determined by RNA sequencing.
Time frame: Up to 3 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Background: PubMed 23728278Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Background: PubMed 18377749Lausevic Z, Lausevic M, Trbojevic-Stankovic J, Krstic S, Stojimirovic B. Predicting multiple organ failure in patients with severe trauma. Can J Surg. 2008 Apr;51(2):97-102.
Background: PubMed 22229650Kvarnstrom AL, Sarbinowski RT, Bengtson JP, Jacobsson LM, Bengtsson AL. Complement activation and interleukin response in major abdominal surgery. Scand J Immunol. 2012 May;75(5):510-6. doi: 10.1111/j.1365-3083.2012.02672.x.
Background: PubMed 22486843Kvarnstrom A, Sokolov A, Swartling T, Kurlberg G, Mollnes TE, Bengtsson A. Alternative pathway activation of complement in laparoscopic and open rectal surgery. Scand J Immunol. 2012 Jul;76(1):49-53. doi: 10.1111/j.1365-3083.2012.02702.x.
Background: PubMed 9315559Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641.
Background: PubMed 25185480Leung CH, Caldarone CA, Wang F, Venkateswaran S, Ailenberg M, Vadasz B, Wen XY, Rotstein OD. Remote Ischemic Conditioning Prevents Lung and Liver Injury After Hemorrhagic Shock/Resuscitation: Potential Role of a Humoral Plasma Factor. Ann Surg. 2015 Jun;261(6):1215-25. doi: 10.1097/SLA.0000000000000877.
Background: PubMed 15304621Konstantinov IE, Arab S, Kharbanda RK, Li J, Cheung MM, Cherepanov V, Downey GP, Liu PP, Cukerman E, Coles JG, Redington AN. The remote ischemic preconditioning stimulus modifies inflammatory gene expression in humans. Physiol Genomics. 2004 Sep 16;19(1):143-50. doi: 10.1152/physiolgenomics.00046.2004. Epub 2004 Aug 10.
Background: PubMed 24363825Pang T, Zhao Y, Zhang NR, Jin SQ, Pan SQ. Transient limb ischemia alters serum protein expression in healthy volunteers: complement C3 and vitronectin may be involved in organ protection induced by remote ischemic preconditioning. Oxid Med Cell Longev. 2013;2013:859056. doi: 10.1155/2013/859056. Epub 2013 Dec 2.
Background: PubMed 18456674Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
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 23035060Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
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-NJMS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Feb 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Comprehensive Complication Index (time frame: 30 days after surgery). 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 NCT03234543, which also lists 18 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 25 Feb 2019.