Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

Study Overview
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Brief Summary
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Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10 minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver) remote to the ischemic limb. The purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery

Official Title
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A Randomized, Double- Blind Multicentric Study of the Effect of Remote Ischemic Preconditioning on Postoperative Complications in Patients Undergoing Major Minimal and Open Visceral Surgery

Conditions
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Postoperative Complication

Intervention / Treatment
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* Device: RIPC with a tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years Undergoing major visceral surgery Exclusion Criteria: < 18 years Pregnancy Signs of Infection/Inflammation on upper limb Shunt Medical history of axillary lymph node dissection Signs of malperfusion of upper limb (i.e. Allen Test) Missing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC (Remote Ischemic Preconditioning)<br>Preoperatively in the operation theater a tourniquet will be applied to the left arm and RIPC will performed. Therefore the tourniquet will be insufflated to suprasystolic pressure levels for 5 minutes, followed by 5 minutes reperfusion (deflated). Three cycles are planned. Duration of the procedure is 30 minutes. | Device: RIPC with a tourniquet<br> <br> |
| No Intervention: Control<br>Preoperatively in the operation theater a tourniquet will be applied to the left arm. The tourniquet will not be insufflated. The tourniquet will be removed after 30 minutes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | 30 days | 
| ICU stay |  | 30 days | 
| Infection composite parameters | CRP, Procalcitonin, Leucocytes | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visceral Surgery, Comprehensive Complication Index, Patient undergoing abdominal surgery