Paracetamol Metabolism Research in Postoperative Hepatic Surgery

Hepatic Disease Clinical Trial

— PARAFOI  

Official title:

Paracetamol Metabolism Research in Postoperative Hepatic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297073
• Other study ID #: 2015_61
• Secondary ID: 2016-002632-32
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: January 2020

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: Gilles Lebuffe, MD,PhD
• Phone: 3 20 44 41 12
• Email: gilles.lebuffe[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Hepatic Disease
• Liver Diseases
• Paracetamol Causing Adverse Effects in Therapeutic Use

Intervention

Drug:
• paracetamol
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

Procedure:
• hepatic surgery

Locations

Country	Name	City	State
France	Hôpital Huriez, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	during the 5 post-operative days
Secondary	Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)		At Day 1, day 3, day 5 post operative
Secondary	Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)		At Day 1, day 3, day 5 post operative
Secondary	Percentage of patients with paracetamolemia greater than 60 mg / mL	60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours	during the 5 post-operative days
Secondary	Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®		At Day 1, day 3, day 5 post operative
Secondary	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).	at day 5
Secondary	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.	at day 5
Secondary	Duration of hospitalization in perioperative intensive care		at 30 days
Secondary	Duration of total hospitalization.		at 30 days
Secondary	Mortality		at 30 days
Secondary	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.	at 30 days