NCT05594641

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 25, 2023

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 21, 2022

Last Update Submit

January 21, 2023

Conditions

Liver SurgeryRemote Ischaemic Preconditioning

Keywords

lactate clearancepostoperative recovery

Outcome Measures

Primary Outcomes (1)

  • 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

    4 hours after the end of liver resection

Secondary Outcomes (3)

  • Postoperative recovery

    hours (RR) or days (ICU), and average of three hours for RR and one day in ICU

  • In-hospital stay

    Days until discharge, an average of 7 days

  • Trend of lactate clearance

    1, 4 and 24 hours after the end of liver resection

Study Arms (2)

T (Treatment)

EXPERIMENTAL

Remote ischaemic preconditioning (RIPC) will be performed before the start of liver resection and the associated Pringle maneuver

Other: Remote ischaemic preconditioning

C (Control)

OTHER

RIPC will be not performed

Other: Control

Interventions

Remote ischaemic preconditioningOTHER

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
T (Treatment)
ControlOTHER

The tourniquet will be applied to the right arm but the cuff will be not inflated

C (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Elective liver surgey (laparotomic, laparoscopic and robotic-assisted)
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Anestesia delle Chirurgie Generali e dei Trapianti, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

  • Paola Aceto, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Aceto, MD

CONTACT

00390630154507paola.aceto@policlinicogemelli.it

Chiara Cambise, MD

CONTACT

00390630154507chiara.cambise@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

November 16, 2022

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

January 25, 2023

Record last verified: 2022-11

Locations

IT(1)