Lactate Clearance After RIPC in Liver Resection (ARAGON)
Primary Purpose
Liver Surgery, Remote Ischaemic Preconditioning
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Remote ischaemic preconditioning
Control
Sponsored by
About this trial
This is an interventional prevention trial for Liver Surgery focused on measuring lactate clearance, postoperative recovery
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
Sites / Locations
- UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
T (Treatment)
C (Control)
Arm Description
Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver
RIPC will be not performed
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postoperative recovery
Lenght of stay on recovery room (RR) or in intensive care (ICU)
In-hospital stay
Hospital stay duration
Trend of lactate clearance
Repeated measure for lactate clearance
Full Information
NCT ID
NCT05594641
First Posted
October 21, 2022
Last Updated
January 21, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05594641
Brief Title
Lactate Clearance After RIPC in Liver Resection
Acronym
ARAGON
Official Title
Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Surgery, Remote Ischaemic Preconditioning
Keywords
lactate clearance, postoperative recovery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T (Treatment)
Arm Type
Experimental
Arm Description
Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver
Arm Title
C (Control)
Arm Type
Other
Arm Description
RIPC will be not performed
Intervention Type
Other
Intervention Name(s)
Remote ischaemic preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The tourniquet will be applied to the right arm but the cuff will be not inflated
Primary Outcome Measure Information:
Title
Lactate clearance
Description
(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
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
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
Title
In-hospital stay
Description
Hospital stay duration
Time Frame
Days until discharge, an average of 7 days
Title
Trend of lactate clearance
Description
Repeated measure for lactate clearance
Time Frame
1, 4 and 24 hours after the end of liver resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Aceto, MD
Phone
00390630154507
Email
paola.aceto@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Cambise, MD
Phone
00390630154507
Email
chiara.cambise@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Aceto, MD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Aceto, MD
Phone
00390630154507
Email
paola.aceto@policlinicogemelli.it
12. IPD Sharing Statement
Learn more about this trial
Lactate Clearance After RIPC in Liver Resection
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