NCT06549062 Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
| NCT ID | NCT06549062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Acetaminophen Toxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2020-09-11 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2020-09-11 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Obese patients may need higher doses of acetaminophen (APAP) for adequate analgesia, due to increased total clearance and distribution volume. APAP-induced hepatotoxicity is mainly caused through CYP2E1 pathway. Its activity is induced by obesity, potentially endangering the safety profile of APAP. Metabolic-dysfunction associated liver disease (MASLD) is an important associated risk factor for APAP induced-hepatotoxicity. The primary endpoint of this study is to validate Van Rongen's prediction model on plasma concentration of paracetamol and its metabolites and extend it to the steady state phase over a period of 30 hours by measuring plasma concentrations of paracetamol and its metabolites and comparing them with the plasma concentrations predicted by the model by Van Rongen et al. In addition, results obtained from venous blood will be compared with results obtained via VAMS after finger stick. If VAMS correlates well with plasma concentrations of paracetamol and its NAPQI adducts, future interventional studies may utilize the patient-friendly VAMS technology in an effort to further investigate the safety and efficacy of higher doses of paracetamol in obese patients and possibly other patient groups. The secondary endpoints of this study are liver function tests before and after 30hrs of paracetamol administration, the VAS pain scores, the surgical pleth index (SPI) and the consumption of piritramide as recorded by a PCIA pump.
Eligibility Criteria
Inclusion Criteria: 1. Adult ≥ 18 \< 70 years old (obese patients) Adult ≥ 18 years old (non-obese patients) 2. Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial 3. Obese scheduled for laparoscopic bariatric surgery Non obese scheduled for laparoscopic surgery 4. Control group BMI ≥18.5 en \<30 kg.m-2 or Obese group BMI \> 35kg.m-2 5. ASA Class I, II or III as assigned by the anaesthesiologist Exclusion Criteria: 1. Allergy or inability to tolerate "paracetamol" 2. Documented Liver disease or liver enzymes \> 3X normal value 3. Kidney disease (eGFR \< 30ml.min-1) 4. Participation in a clinical trial within the past 30 days 5. Chronic alcohol abuse or alcohol intake \<72hrs 6. Gilbert-Meulengracht-syndroom 7. Chronic malnutrition 8. Intake of medication with influence on CYP2E1 or UDP-glucuronosyltransferase 9. Pregnancy
Contact & Investigator
Luc De Baerdemaeker, Md,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06549062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acetaminophen Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06549062 currently recruiting?
Yes, NCT06549062 is actively recruiting participants. Contact the research team at luc.debaerdemaeker@ugent.be for enrollment information.
Where is the NCT06549062 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06549062 clinical trial?
NCT06549062 is sponsored by University Hospital, Ghent. The principal investigator is Luc De Baerdemaeker, Md,PhD at University Hospital, Ghent. The trial plans to enroll 70 participants.