Lactate Clearance After RIPC in Liver Resection

Liver Surgery Clinical Trial

— ARAGON  

Official title:

Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594641
• Other study ID #: 5033
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: February 2024

Study information

• Verified date: November 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Paola Aceto, MD
• Phone: 00390630154507
• Email: paola.aceto[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Liver Surgery
• Remote Ischaemic Preconditioning

Intervention

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

Locations

Country	Name	City	State
Italy	UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	In-hospital stay	Hospital stay duration	Days until discharge, an average of 7 days
Secondary	Trend of lactate clearance	Repeated measure for lactate clearance	1, 4 and 24 hours after the end of liver resection