Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01764555
First received: December 10, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation


Condition Intervention Phase
Morbid Obesity
Drug: acetaminophen 2 g
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Difference in volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Liver function tests in morbidly obese patients in comparison with normal weight patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: normal weight patients
normal weight patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g
Experimental: mobidly obese patients
morbidly obese patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for morbidly obese patients:

  • BMI > 40 kg/m2 undergoing bariatric surgery.
  • Patients between 18 - 60 years old
  • ASA physical classification of II or III
  • All racial and ethnic groups will be included

Inclusion criteria for control group:

  • BMI between 18 and 25 kg/m2 undergoing general surgery
  • Patients between 18 - 60 years old
  • ASA (American Society of Anesthesiology) physical classification of I, II or III
  • All racial and ethnic groups will be included

Exclusion criteria for all study arms:

  • Renal insufficiency
  • Liver disease
  • Patients with Gilbert-Meulengracht syndrome
  • Chronic alcohol intake or use of alcohol within last 72 hours
  • Pregnancy or breastfeeding
  • Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
  • Diabetes mellitus type II patients
  • Smoking
  • Acetaminophen intake before the study (24 hours before study)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764555

Contacts
Contact: Anne van Rongen, MSc 030-6093500 a.van.rongen@antoniusziekenhuis.nl

Locations
Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Anne van Rongen, MSc    030-6093500    a.van.rongen@antoniusziekenhuis.nl   
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Catherijne Knibbe, Prof dr St. Antonius Hospital
  More Information

No publications provided

Responsible Party: Catherijne Knibbe, Prof. dr., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01764555     History of Changes
Other Study ID Numbers: APAP study, 2012-000956-32
Study First Received: December 10, 2012
Last Updated: January 7, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 01, 2014