Lactate Clearance After RIPC in Liver Resection

Study Overview
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Brief Summary
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The primary aim of the study is the evaluation of the efficacy of remote ischemic preconditioning (RIPC) in terms of increase of the clearance of lactates 4 hours after the end of the hepatic resection. The secondary aims of the study are represented by the evaluation of the patients' postoperative recovery and the restoration of a normal lactate metabolism.

Detailed Description
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Hepatic surgery includes clamping of the hepatic peduncle (Pringle maneuver) to control intraoperative bleeding with a consequent reduction of postoperative complications. Surgical manipulations and Pringle maneuver, especially if prolonged and/or repeated, can cause ischemia-reperfusion damage. The technique of regional ischemic preconditioning was introduced to improve tolerance to ischemia. However, the scientific evidence currently does not support the routine use of regional ischemic preconditioning in hepatic surgery. It has recently been demonstrated that ischemic preconditioning can be effective when performed in the upper limb (RIPC). The main advantages of the remote ischaemic preconditiong compared to the regional one are the ease of use, the reduction of surgical time and hepatic ischemia. One of the most relevant epiphenomena of hepatic ischemia during hepatectomy is an increase in lactate levels in the immediate postoperative period that can be associated with an unfavorable outcome and can affect relevant clinical choices such as admission to intensive care. However, no previous studies have investigated the effectiveness of RIPC in improving lactate clearance after liver resection. The investigators hypothesized that applying RIPC before the start of the hepatic resection and the associated Pringle maneuvers could significantly increase lactate clearance 4 hours after the end of liver resection.

Official Title
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Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections

Conditions
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Liver Surgery, Remote Ischaemic Preconditioning

Intervention / Treatment
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* Other: Remote ischaemic preconditioning
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Elective liver surgey (laparotomic, laparoscopic and robotic-assisted) Signed informed consent Exclusion Criteria: Age <18 years Previous liver intervention including surgical and non surgical approach such as liver radiofrequency ablation and radiation therapy Severe cardiopulmunary diseases Refusal to participate

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
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T (Treatment)<br>Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver | Other: Remote ischaemic preconditioning<br>* A tourniquet will be applied to the right arm and it will be inflated (3 cycles, each lasting 5 minutes, at a pressure of 200 mmHg); each cycle is followed by 5 minutes of resting<br>* Other names: RIPC;|
| Other: C (Control)<br>RIPC will be not performed | Other: Control<br>* The tourniquet will be applied to the right arm but the cuff will be not inflated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate clearance | (lactate at the end of liver resection minus lactate at 4 hours after the end of liver resection)*100 to lactate at the end of liver resection | 4 hours after the end of liver resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery | Lenght of stay on recovery room (RR) or in intensive care (ICU) | hours (RR) or days (ICU), and average of three hours for RR and one day in ICU | 
| In-hospital stay | Hospital stay duration | Days until discharge, an average of 7 days | 
| Trend of lactate clearance | Repeated measure for lactate clearance | 1, 4 and 24 hours after the end of liver resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactate clearance, postoperative recovery