Tissue Penetration of Paracetamol in Pediatric Intensive Care Patients
NCT07916831, Completed, University Hospital, Ghent
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Tissue Penetration of Paracetamol in Pediatric Intensive Care Patients | ClinicalTrials.gov |
| NCT number | NCT07916831 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 31 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Ghent | ClinicalTrials.gov |
| Conditions | Pediatric Critical Illness, Brain Injuries, Traumatic, Brain Neoplasms, Intracranial Hypertension, Hydrocephalus, Central Nervous System Infections | ClinicalTrials.gov |
| Interventions | Paracetamol, Pharmacokinetic sampling (blood and CSF microsampling) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Plasma pharmacokinetics of paracetamol after the first intravenous dose | Up to 5 samples at variable time points 0-6 hours after the first intravenous paracetamol dose | Paracetamol concentrations (mg/L) measured in blood volumetric absorptive microsamples and converted to plasma concentrations, used to describe plasma pharmacokinetics (e.g., clearance and volume of distribution) in first-dose conditions. | ClinicalTrials.gov |
| Primary | Plasma pharmacokinetics of paracetamol at steady state | Up to 5 samples at variable time points 0-6 hours after a steady-state intravenous paracetamol dose | Paracetamol concentrations (mg/L) measured in blood volumetric absorptive microsamples and converted to plasma concentrations, used to describe plasma pharmacokinetics (e.g., clearance and volume of distribution) in steady-state conditions. | ClinicalTrials.gov |
| Primary | Cerebrospinal fluid pharmacokinetics of paracetamol | Up to 5 samples at variable time points 0-24 hours after the first intravenous paracetamol infusion | Paracetamol concentrations (mg/L) in cerebrospinal fluid (CSF) sampled from the external ventricular drain, used to describe CSF pharmacokinetics and the penetration of paracetamol into CSF relative to plasma in first-dose and steady-state conditions. | ClinicalTrials.gov |
| Primary | Plasma concentrations of toxic paracetamol metabolites (paracetamol-protein adducts) | At the blood pharmacokinetic sampling times (0-6 hours after the first dose and 0-6 hours after a steady-state dose) | Concentrations of paracetamol-protein adducts (measured as paracetamol-cysteine after proteolytic digestion), a biomarker of exposure to the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI), used to identify the risk of latent hepatotoxicity of paracetamol in children with severe intracranial pathology. | ClinicalTrials.gov |
| Secondary | Covariates of paracetamol pharmacokinetics | All pharmacokinetic samples: 0-6 hours after the first dose and after a steady-state dose (blood), 0-24 hours after the first infusion (CSF) | Patient characteristics (e.g., body weight, age, organ function and severity of illness) that explain between-patient variability in paracetamol pharmacokinetics, identified with a population pharmacokinetic model that is used to predict optimal dosing regimens in individual paediatric patients. | ClinicalTrials.gov |
| Secondary | Influence of blood-brain barrier disruption on paracetamol pharmacokinetics | Up to 5 CSF samples 0-24 hours after the first intravenous paracetamol infusion, with paired blood samples | Comparison of paracetamol plasma and CSF pharmacokinetics between subpopulations with different intracranial pathology (e.g., neurotrauma versus brain tumour) as an indicator of the influence of blood-brain barrier disruption on the pharmacokinetics of a centrally acting drug. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 32035980 | RESULT | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)