Liver Surgery, Remote Ischaemic Preconditioning
Conditions
Keywords
lactate clearance, postoperative recovery
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.
Interventions
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
OTHERControl
The tourniquet will be applied to the right arm but the cuff will be not inflated
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactate clearance | 4 hours after the end of liver resection | (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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recovery | hours (RR) or days (ICU), and average of three hours for RR and one day in ICU | Lenght of stay on recovery room (RR) or in intensive care (ICU) |
| In-hospital stay | Days until discharge, an average of 7 days | Hospital stay duration |
| Trend of lactate clearance | 1, 4 and 24 hours after the end of liver resection | Repeated measure for lactate clearance |
Countries
Italy
Contacts
Primary ContactPaola Aceto, MD
Backup ContactChiara Cambise, MD
Outcome results
None listed