Liver SurgeryARAGONNCT05594641
Lactate Clearance After RIPC in Liver Resection
A study testing Remote ischaemic preconditioning in people with Liver Surgery and Remote Ischaemic Preconditioning, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Surgery, Remote Ischaemic Preconditioning
- What is being tested?
- Remote ischaemic preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Elective liver surgey (laparotomic, laparoscopic and robotic-assisted)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Paola Aceto, MD, 00390630154507, paola.aceto@policlinicogemelli.it
About this study
Official title: Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections
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.
Read the 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
- Being tested
- Remote ischaemic preconditioning, Control
- Keywords
- lactate clearance, postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic preconditioningOther
Also called RIPC
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
ControlOther
The tourniquet will be applied to the right arm but the cuff will be not inflated
| Study group | Role | What they receive |
|---|---|---|
| T (Treatment) | Experimental | Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver Receives: Other: Remote ischaemic preconditioning |
| C (Control) | Other | RIPC will be not performed Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours after the end of liver resection
Secondary outcomes (3)
Postoperative recovery
Lenght of stay on recovery room (RR) or in intensive care (ICU)
Measured: hours (RR) or days (ICU), and average of three hours for RR and one day in ICU
In-hospital stay
Hospital stay duration
Measured: Days until discharge, an average of 7 days
Trend of lactate clearance
Repeated measure for lactate clearance
Measured: 1, 4 and 24 hours after the end of liver resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start16 Nov 2022
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Aceto, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594641
- Sponsor's protocol ID
- 5033
- Acronym
- ARAGON
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Clearance After Remote Ischaemic Preconditioning in Liver Resections
- ClinicalTrials.gov ID
- NCT05594641
- Acronym / sponsor ID
- ARAGON / 5033
- Conditions
- Liver Surgery, Remote Ischaemic Preconditioning
- Keywords
- lactate clearance, postoperative recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| T (Treatment) | Experimental | Other: Remote ischaemic preconditioningRemote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver |
| C (Control) | Other | Other: ControlRIPC will be not performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Elective liver surgey (laparotomic, laparoscopic and robotic-assisted)
- Signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischaemic preconditioningAlso: RIPCA 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 | T (Treatment) |
| ControlThe tourniquet will be applied to the right arm but the cuff will be not inflated | Other | C (Control) |
Primary outcome
Lactate clearance
Time frame: 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
3 secondary outcomes
Postoperative recovery
Time frame: hours (RR) or days (ICU), and average of three hours for RR and one day in ICU
In-hospital stay
Time frame: Days until discharge, an average of 7 days
Trend of lactate clearance
Time frame: 1, 4 and 24 hours after the end of liver resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Aceto, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic preconditioning in people with Liver Surgery and Remote Ischaemic Preconditioning, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Aceto, MD (00390630154507, paola.aceto@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate clearance (time frame: 4 hours after the end of liver resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.