Lactate Clearance After RIPC in Liver Resection (ARAGON)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Liver Surgery; Remote Ischaemic Preconditioning

Treatments: Other: Control; Other: Remote ischaemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05594641

5033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

T (Treatment)

Experimental group

Description:

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

Treatment:

Other: Remote ischaemic preconditioning

C (Control)

Other group

Description:

RIPC will be not performed

Treatment:

Other: Control