Last reviewed · How we verify
NCT06549062
Pharmacokinetics and Pharmacodynamics of Intravenous Paracetamol in Morbidly Obese and Non- Obese Patients.
trial in Acetaminophen Toxicity in 70 participants. Currently enrolling.
1 January 2025
Quick facts
| Lead sponsor | University Hospital, Ghent |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 70 |
| Start date | 11 September 2020 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Belgium |
Conditions studied
- Acetaminophen Toxicity — all drugs for Acetaminophen Toxicity →
- Obesity, Morbid — all drugs for Obesity, Morbid →
Sponsor
University Hospital, Ghent
Who can join
Adults 18 to 70, any sex, with Acetaminophen Toxicity or Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06549062
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other University Hospital, Ghent trials
Trials by the same sponsor.
- NCT07584486 — Development of a New Simplified Tool to Predict LNPCPs Histology and Assess the Risk of Submucosal Invasive Cancer. The · NA · not yet recruiting
- NCT07327450 — Coaching Doctors and Nurses to Improve Ethical Decision-making in Team · NA · not yet recruiting
- NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
- NCT07387328 — Validation of New sEMG Electrode Placement Guidelines for the Triceps Surae in Post-stroke Individuals. · not yet recruiting
- NCT07237399 — Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM) · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06549062 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
- Last refreshed: 12 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06549062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing