Remote Ischemic Conditioning (RIC) to Decrease Post-Operative Complications After Major Abdominal Surgery - A Phase IIa Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comprehensive Complication Index
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Subjects with lower extremity paralysis
- •Lower extremity amputees
- •Known, documented peripheral arterial disease
- •Body mass index > 45
- •Trauma patients
- •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)
- •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.
- •Non-elective surgeries (urgent or emergent surgeries)
- •General surgical procedures with no planned intra-abdominal component
研究组 & 干预措施
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.
干预措施: Remote ischemic conditioning (Procedure)
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).
干预措施: No Remote ischemic conditioning (Procedure)
结局指标
主要结局
Comprehensive Complication Index
时间窗: 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/.
次要结局
- 30-day mortality(Up to 30 days)
- Plasma acute phase reactant proteins (CRP, alpha-1- acid glycoprotein, FGN, and haptoglobin)(Up to 3 days)
- Hospital days(Up to 30 days)
- Peripheral blood leukocyte gene expression profiles determined by RNA sequencing.(Up to 3 days)
- Completion all three interventions(Up to 3 days)
- Plasma complement levels (C2, C4b, C5, C5a, and C5b-9)(Up to 3 days)
- Plasma cytokines levels (TNF-a, IL - 1, 6, 8 and 10)(Up to 3 days)
研究者
Baburao Koneru, MD, MPH
Professor of Surgery
Rutgers, The State University of New Jersey