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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
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.
|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|
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.
- 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/.
- Completion all three interventions [ Time Frame: Up to 3 days ]Proportions of subjects completing all three research interventions
- Hospital days [ Time Frame: Up to 30 days ]Number of days to discharge from the hospital after surgery
- 30-day mortality [ Time Frame: Up to 30 days ]Proportions of patients dying within 30 days after surgery
- 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
- 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
- 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
- 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
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
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|Principal Investigator:||Baburao Koneru, MD, MPH||Rutgers-NJMS|