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Remote Ischemic Conditioning in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03234543
Recruitment Status : Unknown
Verified February 2019 by Baburao Koneru, MD, MPH, Rutgers, The State University of New Jersey.
Recruitment status was:  Enrolling by invitation
First Posted : July 31, 2017
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Baburao Koneru, MD, MPH, Rutgers, The State University of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laparotomy Laparoscopy Retroperitoneal Disease Pelvis Disease Pancreatic Diseases Liver Diseases Gastrointestinal Disease Urologic Diseases Complication of Surgical Procedure Procedure: Remote ischemic conditioning Procedure: No Remote ischemic conditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description:

The study will be conducted in a double-masked fashion. Investigative team member/s that will carry out randomization and administer the intervention will not be involved in evaluation of clinical and laboratory outcomes. The primary surgical team, nurses, and any consulting services caring for the patient will be unaware of the group assignment. Other care providers will not be informed of the group assignment. Outcome assessors will not be involved in randomization and administration of the RIC intervention. Adequate steps are in place to mask the outcome assessors (clinical and laboratory) from knowing group assignment.

Subjects will be masked from recognizing which group they are in in the following manner: a) Subjects will not be informed of the group assignment throughout their participation in the study; b) subjects randomized to No RIPC will have a tourniquet placed on the thigh and inflated.

Primary Purpose: Prevention
Official Title: Remote Ischemic Conditioning (RIC) to Decrease Post-Operative Complications After Major Abdominal Surgery - A Phase IIa Trial
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2020

Arm Intervention/treatment
Experimental: Remote Ischemic Conditioning
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.
Procedure: Remote ischemic conditioning
Placement of blood pressure cuff to lower extremity in order to induce temporary and reversible ischemia.

Sham Comparator: No Remote Ischemic Conditioning
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).
Procedure: No Remote ischemic conditioning
Placement of blood pressure cuff to lower extremity with minimal inflation without inducing ischemia.




Primary Outcome Measures :
  1. 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/.


Secondary Outcome Measures :
  1. Completion all three interventions [ Time Frame: Up to 3 days ]
    Proportions of subjects completing all three research interventions

  2. Hospital days [ Time Frame: Up to 30 days ]
    Number of days to discharge from the hospital after surgery

  3. 30-day mortality [ Time Frame: Up to 30 days ]
    Proportions of patients dying within 30 days after surgery

  4. Plasma complement levels (C2, C4b, C5, C5a, and C5b-9) [ Time Frame: Up to 3 days ]
    Measured at baseline, an hour after skin closure, completion of second and third research intervention

  5. Plasma cytokines levels (TNF-a, IL - 1, 6, 8 and 10) [ Time Frame: Up to 3 days ]
    Plasma cytokine levels at baseline, an hour after skin closure, completion of second and third research intervention

  6. Plasma acute phase reactant proteins (CRP, alpha-1- acid glycoprotein, FGN, and haptoglobin) [ Time Frame: Up to 3 days ]
    Measured at baseline, an hour after skin closure, completion of second and third research intervention

  7. Peripheral blood leukocyte gene expression profiles determined by RNA sequencing. [ Time Frame: Up to 3 days ]
    Measured at baseline, an hour after skin closure, completion of second and third research intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects with lower extremity paralysis
  2. Lower extremity amputees
  3. Known, documented peripheral arterial disease
  4. Body mass index > 45
  5. Pregnancy
  6. Trauma patients
  7. Organ transplant recipients
  8. Prior major surgery during current hospitalization (for instance, a patient undergoing re-laparotomy for a complication from a previous procedure)
  9. Patient taking sulfonylureas or nitrates prior to or during admission (listed in Appendix B)

    a. 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.

  10. Non-elective surgeries (urgent or emergent surgeries)
  11. General surgical procedures with no planned intra-abdominal component

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234543


Locations
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United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Baburao Koneru, MD, MPH Rutgers-NJMS
  Study Documents (Full-Text)

Documents provided by Baburao Koneru, MD, MPH, Rutgers, The State University of New Jersey:
Informed Consent Form  [PDF] May 22, 2017
Statistical Analysis Plan  [PDF] September 8, 2017
Study Protocol  [PDF] September 8, 2017

Publications:

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Responsible Party: Baburao Koneru, MD, MPH, Professor of Surgery, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03234543    
Other Study ID Numbers: Pro20160001420
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baburao Koneru, MD, MPH, Rutgers, The State University of New Jersey:
Abdominal Surgery
Pre-conditioning
Remote Ischemic Conditioning
Post-Operative Complications
Acute Phase Response
Additional relevant MeSH terms:
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Liver Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Urologic Diseases
Postoperative Complications
Pathologic Processes