Clinical trial NCT05594641: Lactate Clearance After RIPC in Liver Resection
Official title: Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Surgery
Remote Ischaemic Preconditioning
Keywords: lactate clearance
postoperative recovery
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate clearance
timeFrame: 4 hours after the end of liver resection
Secondary outcomes:
measure: Postoperative recovery
timeFrame: hours (RR) or days (ICU), and average of three hours for RR and one day in ICU
measure: In-hospital stay
timeFrame: Days until discharge, an average of 7 days
measure: Trend of lactate clearance
timeFrame: 1, 4 and 24 hours after the end of liver resection
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Paola Aceto, MD
role: PRINCIPAL_INVESTIGATOR
References: