Lactate Clearance After RIPC in Liver Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2024-02-29

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.

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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.

Conditions

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Liver Surgery Remote Ischaemic Preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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T (Treatment)

Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver

Group Type EXPERIMENTAL

Remote ischaemic preconditioning

Intervention Type OTHER

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

C (Control)

RIPC will be not performed

Group Type OTHER

Control

Intervention Type OTHER

The tourniquet will be applied to the right arm but the cuff will be not inflated

Interventions

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Remote ischaemic preconditioning

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

Intervention Type OTHER

Control

The tourniquet will be applied to the right arm but the cuff will be not inflated

Intervention Type OTHER

Other Intervention Names

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RIPC

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No