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Paracetamol Metabolism Research in Postoperative Hepatic Surgery (PARAFOI)

Primary Purpose

Paracetamol Causing Adverse Effects in Therapeutic Use, Hepatic Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

paracetamol

hepatic surgery

About this trial

This is an interventional diagnostic trial for Paracetamol Causing Adverse Effects in Therapeutic Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
Verification of the understanding of the protocol,

Exclusion Criteria:

Patients classified ASA 4 or 5,
Allergy or intolerance to indocyanine green
Allergy or intolerance to paracetamol,
Taking of paracetamol the week before the intervention,
Patient less than 60 Kgs (because decrease of doses of paracetamol),
Emergency surgery, palliative surgery and surgical recovery,
Psychic disorder,
Contra-indication to a treatment used during the study,
incapable major,
Intellectual incapacity preventing proper understanding of the protocol,
Pregnant or nursing woman,

Sites / Locations

Hôpital Huriez, CHRURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

major hepatic surgery

hepatic surgery

hepatic surgery recovery

Arm Description

resection greater than or equal to three hepatic segments

resection less than three hepatic segments

Outcomes

Primary Outcome Measures

Dosing and kinetics of paracetamolemia

this determination of the plasma paracetamol dosage on D0 (H6: 6 hours after the end of the procedure) and D1 D2 D3 D4 D5 (samples taken at 6 am each day just before the injection of paracetamol whose administration hours will be 6h 12h 18h and midnight)

Secondary Outcome Measures

Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)

Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)

Percentage of patients with paracetamolemia greater than 60 mg / mL

60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours

Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®

Rate of postoperative hepatocellular insufficiency

The postoperative hepatocellular insufficiency according to the 50/50 criteria (TP <50% and bilirubinemia> 50 μmol / L on the 5th day) according to the type of hepatic resection (with or without clamping, continuous or discontinuous, duration intervention).

Occurrence of complications related to hepatic failure

the complications related to hepatic failure not falling within the "50/50" criteria: jaundice, hepatic encephalopathy, coagulation disorders, ascites, cytolysis, cholestasis. Other medical and surgical. Duration of hospitalization in perioperative intensive care and duration of total hospitalization. Mortality at 30 days.

Duration of hospitalization in perioperative intensive care

Duration of total hospitalization.

Mortality

Composite characteristics of surgery.

Characteristics of surgery: duration of intervention, numbers, duration and types of vascular clamping, detailed description of the type of liver resection performed, quantification of bleeding.

Full Information

NCT ID

NCT03297073

First Posted

September 25, 2017

Last Updated

October 10, 2019

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT03297073

Brief Title

Paracetamol Metabolism Research in Postoperative Hepatic Surgery

Acronym

PARAFOI

Official Title

Paracetamol Metabolism Research in Postoperative Hepatic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 20, 2016 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable. Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paracetamol Causing Adverse Effects in Therapeutic Use, Hepatic Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

major hepatic surgery

Arm Type

Experimental

Arm Description

resection greater than or equal to three hepatic segments

Arm Title

hepatic surgery

Arm Type

Experimental

Arm Description

resection less than three hepatic segments

Arm Title

hepatic surgery recovery

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

paracetamol

Intervention Description

Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h. The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form

Intervention Type

Procedure

Intervention Name(s)

hepatic surgery

Primary Outcome Measure Information:

Title

Dosing and kinetics of paracetamolemia

Description

Time Frame

during the 5 post-operative days

Secondary Outcome Measure Information:

Title

Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)

Time Frame

At Day 1, day 3, day 5 post operative

Title

Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)

Time Frame

At Day 1, day 3, day 5 post operative

Title

Percentage of patients with paracetamolemia greater than 60 mg / mL

Description

60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours

Time Frame

during the 5 post-operative days

Title

Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®

Time Frame

At Day 1, day 3, day 5 post operative

Title

Rate of postoperative hepatocellular insufficiency

Description

Time Frame

at day 5

Title

Occurrence of complications related to hepatic failure

Description

Time Frame

at day 5

Title

Duration of hospitalization in perioperative intensive care

Time Frame

at 30 days

Title

Duration of total hospitalization.

Time Frame

at 30 days

Title

Mortality

Time Frame

at 30 days

Title

Composite characteristics of surgery.

Description

Characteristics of surgery: duration of intervention, numbers, duration and types of vascular clamping, detailed description of the type of liver resection performed, quantification of bleeding.

Time Frame

at 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency, ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient), Verification of the understanding of the protocol, Exclusion Criteria: Patients classified ASA 4 or 5, Allergy or intolerance to indocyanine green Allergy or intolerance to paracetamol, Taking of paracetamol the week before the intervention, Patient less than 60 Kgs (because decrease of doses of paracetamol), Emergency surgery, palliative surgery and surgical recovery, Psychic disorder, Contra-indication to a treatment used during the study, incapable major, Intellectual incapacity preventing proper understanding of the protocol, Pregnant or nursing woman,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gilles Lebuffe, MD,PhD

Phone

3 20 44 41 12

Ext

+33

gilles.lebuffe@chru-lille.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles Lebuffe, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Huriez, CHRU

City

Lille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles Lebuffe, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Paracetamol Metabolism Research in Postoperative Hepatic Surgery

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