NCT05594641

Lactate Clearance After RIPC in Liver Resection

Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Surgery
• Remote Ischaemic Preconditioning

Interventions

Type	Name	Description
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	Control	The tourniquet will be applied to the right arm but the cuff will be not inflated

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2022-10-26
• Last updated: 2023-01-25

Locations

1 site across 1 country: Italy