Pediatric Critical IllnessTIPPICNCT07916831
Tissue Penetration of Paracetamol in Pediatric Intensive Care Patients
An observational study of Pediatric Critical Illness and Brain Injuries, Traumatic, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
TIPPIC was a single-centre, prospective, observational pharmacokinetic study in critically ill children aged 1 month to 15 years who were admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain (EVD) in place and who received intravenous (IV) paracetamol as… Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Pediatric Critical Illness, Brain Injuries, Traumatic, Brain Neoplasms
- What is being tested?
- Paracetamol and Pharmacokinetic sampling (blood and CSF microsampling)
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jan 2017to 20 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill children aged 1 month to 15 years admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain in place (e.g., for a brain tumour, intracranial infection, hydrocephalus or traumatic brain injury) who received intravenous paracetamol as part of routine clinical care.
Who may be able to join
- Patient admitted to the paediatric intensive care unit
- Age 1 month to 15 years
- External ventricular drain in place
- Receiving intravenous paracetamol
- Intra-arterial or intravenous access, other than the drug infusion line, available for blood sampling
Who cannot join
- No catheter in place for blood sampling
- Absence of parental/patient consent
- Known hypersensitivity to paracetamol
- Extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Penetration of Paracetamol and Exposure to Toxic Metabolites in Paediatric Intensive Care Patients (TIPPIC)
TIPPIC was a single-centre, prospective, observational pharmacokinetic study in critically ill children aged 1 month to 15 years who were admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain (EVD) in place and who received intravenous (IV) paracetamol as part of routine care.
Paracetamol is thought to act in the central nervous system and must cross the blood-brain barrier to reach its target. Severe intracranial pathology (for example traumatic brain injury or brain tumours) can disrupt this barrier, and critical illness and growth alter drug disposition. Cerebrospinal fluid (CSF) concentrations after IV paracetamol had not been described in this population. The EVD, in place for clinical reasons, allows repeated CSF sampling.
Read more
The study aimed to:
- describe the pharmacokinetics of paracetamol in plasma and CSF after the first dose and at steady state;
- measure paracetamol-protein adducts, a marker of exposure to the toxic metabolite NAPQI and of the risk of latent hepatotoxicity;
- identify covariates of paracetamol pharmacokinetics and develop a population pharmacokinetic model to predict optimal dosing regimens in individual children;
- describe the influence of blood-brain barrier disruption on paracetamol pharmacokinetics.
Blood and CSF were collected by volumetric absorptive microsampling (10 microliters per sample).
Read the detailed description
Design: single-centre, prospective, observational study in the paediatric intensive care unit (PICU) of Ghent University Hospital, Ghent, Belgium. Intravenous paracetamol was prescribed by the treating intensivist as part of routine clinical care (standard regimen 15 mg/kg every 6 hours); the study did not assign or change the treatment.
Blood sampling: through an arterial (preferred) or venous catheter already in place and different from the paracetamol infusion line, following an individualised sampling scheme: at most 5 samples at variable time points in the 0-6 h interval after the first IV paracetamol dose (first-dose conditions) and at most 5 samples in the 0-6 h interval after a dose at steady state (steady-state conditions).
CSF sampling: in a strictly aseptic way through the proximal three-way valve of the external ventricular drain system, less frequently than blood sampling: at most 5 samples at variable time points in the 0-24 h interval after the first paracetamol infusion (first-dose and steady-state conditions).
Each blood and CSF sample consisted of 10 microliters absorbed by a volumetric absorptive microsampling (VAMS) device. Per protocol, an additional 0.3 mL EDTA blood sample could be collected at each blood sampling moment to validate the VAMS technique. The total blood volume taken for study purposes was at most 4 mL per patient, below 2.4 mL/kg in line with EMA guidance for paediatric trials. Samples were stored at -80 degrees C in the biobank of the Heymans Institute of Pharmacology, Ghent University, and analysed with validated liquid chromatography methods at the Laboratory of Toxicology, Faculty of Pharmaceutical Sciences, Ghent University.
Clinical data: age, weight, length, primary reason for admission, pre-existing chronic disease (especially liver and kidney disease), PRISM II score at admission and, on sampling days, PELOD score, mechanical ventilation, vasopressors, intracranial pressure, serum creatinine and Schwartz creatinine clearance, serum albumin and serum cystatin C; dosing regimen (start and stop times of infusions), duration of treatment, co-medication and the catheter used for sampling.
Consent: written informed consent from the parents or legal representatives, and from the patient if older than 12 years (intubated patients older than 12 years were informed after extubation). When there was no time to obtain written consent before the first samples, oral consent was obtained by telephone from a legal representative in the presence of an independent member of the intensive care team, followed by written consent the same day. Samples were destroyed if consent was refused.
Sample size: 50 patients were planned (based on similar studies). Patients were enrolled between January 2017 and December 2018.
This study was registered retrospectively, after completion of enrolment.
- Conditions
- Pediatric Critical Illness, Brain Injuries, Traumatic, Brain Neoplasms, Intracranial Hypertension, Hydrocephalus, Central Nervous System Infections
- Being tested
- Paracetamol, Pharmacokinetic sampling (blood and CSF microsampling)
- Keywords
- Paracetamol, Acetaminophen, Pharmacokinetics, Population pharmacokinetics, Cerebrospinal fluid, External ventricular drain, Blood-brain barrier, Pediatric intensive care, Volumetric absorptive microsampling, Paracetamol-protein adducts, NAPQI, Children
- Medical subject headings
- Brain Injuries, Traumatic, Brain Neoplasms, Intracranial Hypertension, Hydrocephalus, Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Intravenous paracetamol prescribed by the treating intensivist as part of routine clinical care (standard regimen 15 mg/kg every 6 hours). Dose and schedule were not assigned or changed by the study.
Pharmacokinetic sampling (blood and CSF microsampling)Other
Volumetric absorptive microsampling (10 microliters per sample) of blood through an existing arterial (preferred) or venous catheter other than the infusion line (at most 5 samples 0-6 h after the first dose and at most 5 samples 0-6 h after a steady-state dose) and of cerebrospinal fluid through the proximal three-way valve of the external ventricular drain (at most 5 samples 0-24 h after the first infusion).
| Study group | Role | What they receive |
|---|---|---|
| PICU children with an external ventricular drain receiving IV paracetamol | Critically ill children aged 1 month to 15 years admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain in place and receiving intravenous paracetamol as part of routine clinical care. Study procedures: blood and cerebrospinal fluid microsampling. Receives: Drug: Paracetamol; Other: Pharmacokinetic sampling (blood and CSF microsampling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetics of paracetamol after the first intravenous 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.
Measured: Up to 5 samples at variable time points 0-6 hours after the first intravenous paracetamol dose
Plasma pharmacokinetics of paracetamol at steady state
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.
Measured: Up to 5 samples at variable time points 0-6 hours after a steady-state intravenous paracetamol dose
Cerebrospinal fluid pharmacokinetics of paracetamol
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.
Measured: Up to 5 samples at variable time points 0-24 hours after the first intravenous paracetamol infusion
Plasma concentrations of toxic paracetamol metabolites (paracetamol-protein adducts)
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.
Measured: At the blood pharmacokinetic sampling times (0-6 hours after the first dose and 0-6 hours after a steady-state dose)
Secondary outcomes (2)
Covariates of paracetamol pharmacokinetics
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.
Measured: 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)
Influence of blood-brain barrier disruption on paracetamol pharmacokinetics
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.
Measured: Up to 5 CSF samples 0-24 hours after the first intravenous paracetamol infusion, with paired blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start23 Jan 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Leiden University
- Responsible party
- Sponsor
- Investigators
- Evelyn Dhont, MD, PhD, Principal investigator, University Hospital, GhentPieter De Cock, Prof. PharmD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916831
- Sponsor's protocol ID
- 2016/0953
- Acronym
- TIPPIC
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because of the small paediatric cohort and the associated re-identification risk under the EU General Data Protection Regulation. De-identified data supporting published results may be made available on reasonable request to the principal investigator, subject to approval by the Ethics Committee of Ghent University Hospital and a data-transfer agreement.
Publications
Delahaye L, Dhont E, De Cock P, De Paepe P, Stove CP. Dried blood microsamples: Suitable as an alternative matrix for the quantification of paracetamol-protein adducts? Toxicol Lett. 2020 May 15;324:65-74. doi: 10.1016/j.toxlet.2020.02.001. Epub 2020 Feb 6.
PubMed 32035980
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Penetration of Paracetamol and Exposure to Toxic Metabolites in Paediatric Intensive Care Patients (TIPPIC)
- ClinicalTrials.gov ID
- NCT07916831
- Acronym / sponsor ID
- TIPPIC / 2016/0953
- Conditions
- Pediatric Critical Illness, Brain Injuries, Traumatic, Brain Neoplasms, Intracranial Hypertension, Hydrocephalus, Central Nervous System Infections
- Keywords
- Paracetamol, Acetaminophen, Pharmacokinetics, Population pharmacokinetics, Cerebrospinal fluid, External ventricular drain, Blood-brain barrier, Pediatric intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Leiden University
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TIPPIC was a single-centre, prospective, observational pharmacokinetic study in critically ill children aged 1 month to 15 years who were admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain (EVD) in place and who received intravenous (IV) paracetamol as part of routine care.
Paracetamol is thought to act in the central nervous system and must cross the blood-brain barrier to reach its target. Severe intracranial pathology (for example traumatic brain injury or brain tumours) can disrupt this barrier, and critical illness and growth alter drug disposition. Cerebrospinal fluid (CSF) concentrations after IV paracetamol had not been described in this population. The EVD, in place for clinical reasons, allows repeated CSF sampling.
The study aimed to:
- describe the pharmacokinetics of paracetamol in plasma and CSF after the first dose and at steady state;
- measure paracetamol-protein adducts, a marker of exposure to the toxic metabolite NAPQI and of the risk of latent hepatotoxicity;
- identify covariates of paracetamol pharmacokinetics and develop a population pharmacokinetic model to predict optimal dosing regimens in individual children;
- describe the influence of blood-brain barrier disruption on paracetamol pharmacokinetics.
Blood and CSF were collected by volumetric absorptive microsampling (10 microliters per sample).
Detailed description
Design: single-centre, prospective, observational study in the paediatric intensive care unit (PICU) of Ghent University Hospital, Ghent, Belgium. Intravenous paracetamol was prescribed by the treating intensivist as part of routine clinical care (standard regimen 15 mg/kg every 6 hours); the study did not assign or change the treatment.
Blood sampling: through an arterial (preferred) or venous catheter already in place and different from the paracetamol infusion line, following an individualised sampling scheme: at most 5 samples at variable time points in the 0-6 h interval after the first IV paracetamol dose (first-dose conditions) and at most 5 samples in the 0-6 h interval after a dose at steady state (steady-state conditions).
CSF sampling: in a strictly aseptic way through the proximal three-way valve of the external ventricular drain system, less frequently than blood sampling: at most 5 samples at variable time points in the 0-24 h interval after the first paracetamol infusion (first-dose and steady-state conditions).
Each blood and CSF sample consisted of 10 microliters absorbed by a volumetric absorptive microsampling (VAMS) device. Per protocol, an additional 0.3 mL EDTA blood sample could be collected at each blood sampling moment to validate the VAMS technique. The total blood volume taken for study purposes was at most 4 mL per patient, below 2.4 mL/kg in line with EMA guidance for paediatric trials. Samples were stored at -80 degrees C in the biobank of the Heymans Institute of Pharmacology, Ghent University, and analysed with validated liquid chromatography methods at the Laboratory of Toxicology, Faculty of Pharmaceutical Sciences, Ghent University.
Clinical data: age, weight, length, primary reason for admission, pre-existing chronic disease (especially liver and kidney disease), PRISM II score at admission and, on sampling days, PELOD score, mechanical ventilation, vasopressors, intracranial pressure, serum creatinine and Schwartz creatinine clearance, serum albumin and serum cystatin C; dosing regimen (start and stop times of infusions), duration of treatment, co-medication and the catheter used for sampling.
Consent: written informed consent from the parents or legal representatives, and from the patient if older than 12 years (intubated patients older than 12 years were informed after extubation). When there was no time to obtain written consent before the first samples, oral consent was obtained by telephone from a legal representative in the presence of an independent member of the intensive care team, followed by written consent the same day. Samples were destroyed if consent was refused.
Sample size: 50 patients were planned (based on similar studies). Patients were enrolled between January 2017 and December 2018.
This study was registered retrospectively, after completion of enrolment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICU children with an external ventricular drain receiving IV paracetamol | – | Drug: Paracetamol, Other: Pharmacokinetic sampling (blood and CSF microsampling)Critically ill children aged 1 month to 15 years admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain in place and receiving intravenous paracetamol as part of routine clinical care. Study procedures: blood and cerebrospinal fluid microsampling. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill children aged 1 month to 15 years admitted to the paediatric intensive care unit (PICU) of Ghent University Hospital with an external ventricular drain in place (e.g., for a brain tumour, intracranial infection, hydrocephalus or traumatic brain injury) who received intravenous paracetamol as part of routine clinical care.
Key inclusion criteria (5 listed)
- Patient admitted to the paediatric intensive care unit
- Age 1 month to 15 years
- External ventricular drain in place
- Receiving intravenous paracetamol
- Intra-arterial or intravenous access, other than the drug infusion line, available for blood sampling
Key exclusion criteria (4 listed)
- No catheter in place for blood sampling
- Absence of parental/patient consent
- Known hypersensitivity to paracetamol
- Extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: AcetaminophenIntravenous paracetamol prescribed by the treating intensivist as part of routine clinical care (standard regimen 15 mg/kg every 6 hours). Dose and schedule were not assigned or changed by the study. | Drug | PICU children with an external ventricular drain receiving IV paracetamol |
| Pharmacokinetic sampling (blood and CSF microsampling)Volumetric absorptive microsampling (10 microliters per sample) of blood through an existing arterial (preferred) or venous catheter other than the infusion line (at most 5 samples 0-6 h after the first dose and at most 5 samples 0-6 h after a steady-state dose) and of cerebrospinal fluid through the proximal three-way valve of the external ventricular drain (at most 5 samples 0-24 h after the first infusion). | Other | PICU children with an external ventricular drain receiving IV paracetamol |
Primary outcome
Plasma pharmacokinetics of paracetamol after the first intravenous dose
Time frame: 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.
Plasma pharmacokinetics of paracetamol at steady state
Time frame: 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.
Cerebrospinal fluid pharmacokinetics of paracetamol
Time frame: 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.
Plasma concentrations of toxic paracetamol metabolites (paracetamol-protein adducts)
Time frame: 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.
2 secondary outcomes
Covariates of paracetamol pharmacokinetics
Time frame: 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)
Influence of blood-brain barrier disruption on paracetamol pharmacokinetics
Time frame: Up to 5 CSF samples 0-24 hours after the first intravenous paracetamol infusion, with paired blood samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 32035980Delahaye L, Dhont E, De Cock P, De Paepe P, Stove CP. Dried blood microsamples: Suitable as an alternative matrix for the quantification of paracetamol-protein adducts? Toxicol Lett. 2020 May 15;324:65-74. doi: 10.1016/j.toxlet.2020.02.001. Epub 2020 Feb 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because of the small paediatric cohort and the associated re-identification risk under the EU General Data Protection Regulation. De-identified data supporting published results may be made available on reasonable request to the principal investigator, subject to approval by the Ethics Committee of Ghent University Hospital and a data-transfer agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Dhont, MD, PhD principal investigator
University Hospital, Ghent
Pieter De Cock, Prof. PharmD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Critical Illness and Brain Injuries, Traumatic, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pharmacokinetics of paracetamol after the first intravenous dose (time frame: Up to 5 samples at variable time points 0-6 hours after the first intravenous paracetamol dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.