Clinical trial NCT03297073: Paracetamol Metabolism Research in Postoperative Hepatic Surgery
Official title: Paracetamol Metabolism Research in Postoperative Hepatic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paracetamol Causing Adverse Effects in Therapeutic Use
Hepatic Disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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,

Primary outcomes:
measure: Dosing and kinetics of paracetamolemia
timeFrame: during the 5 post-operative days
Secondary outcomes:
measure: Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)
timeFrame: At Day 1, day 3, day 5 post operative
measure: Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)
timeFrame: At Day 1, day 3, day 5 post operative
measure: Percentage of patients with paracetamolemia greater than 60 mg / mL
timeFrame: during the 5 post-operative days
measure: Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®
timeFrame: At Day 1, day 3, day 5 post operative
measure: Rate of postoperative hepatocellular insufficiency
timeFrame: at day 5
measure: Occurrence of complications related to hepatic failure
timeFrame: at day 5
measure: Duration of hospitalization in perioperative intensive care
timeFrame: at 30 days
measure: Duration of total hospitalization.
timeFrame: at 30 days
measure: Mortality
timeFrame: at 30 days
measure: Composite characteristics of surgery.
timeFrame: at 30 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Huriez, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: