An interventional study of Remote ischaemic preconditioning and Control in Liver Surgery and Remote Ischaemic Preconditioning, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Prevention
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.
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.
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's planned enrollment of 74 is close to the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Exclusion Criteria:
Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver
Other: Remote ischaemic preconditioning
RIPC will be not performed
Other: Control
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
Also known as: RIPC
The tourniquet will be applied to the right arm but the cuff will be not inflated
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
Time frame: 4 hours after the end of liver resection
Postoperative recovery
Lenght of stay on recovery room (RR) or in intensive care (ICU)
Time frame: hours (RR) or days (ICU), and average of three hours for RR and one day in ICU
In-hospital stay
Hospital stay duration
Time frame: Days until discharge, an average of 7 days
Trend of lactate clearance
Repeated measure for lactate clearance
Time frame: 1, 4 and 24 hours after the end of liver resection
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS