Lactate Clearance After RIPC in Liver Resection (ARAGON)

Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Surgery; Remote Ischaemic Preconditioning
• Intervention / Treatment: Other: Remote ischaemic preconditioning; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiara Cambise, MD; Phone Number: 00390630154507; Email: chiara.cambise@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T (Treatment); Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver	Other: 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; Other Names: RIPC
Other: C (Control); RIPC will be not performed	Other: Control; The tourniquet will be applied to the right arm but the cuff will be not inflated

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Paola Aceto, MD, Fondazione Policlinico Universitario Agostino Gemelli Irccs

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: postoperative recovery; lactate clearance
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 5033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No