Lactate Clearance After RIPC in Liver Resection

Not Applicable

Recruiting

• Conditions: Liver Surgery; Remote Ischaemic Preconditioning
• Interventions: Other: Control; Other: Remote ischaemic preconditioning

• Registration Number: NCT05594641
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Status Verified: 2022-11
• Study Start: 2022-11-16
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25
• Primary Completion: 2024-01
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C (Control)	Control	RIPC will be not performed
T (Treatment)	Remote ischaemic preconditioning	Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver

Primary Outcome Measures

Name	Time	Method
Lactate clearance	4 hours after the end of liver resection	(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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy