Acute Hydrocarbon ToxicityNCT06151301
Evaluation of the Role of Poisoning Severity Score, Serum Procalcitonin and C-reactive Protein in Acute Hydrocarbon Intoxicated Cases Admitted to the Poison Control Center Ain Shams University Hospitals
An observational study of Acute Hydrocarbon Toxicity, run by Sohag University at 1 site in Egypt.
Trial summary
Hydrocarbons are a primary energy source in modern society. They are present in many common household and occupational products, including motor fuels, paint thinners, cleaning agents, lotions, and industrial solvents. Unfortunately, these products are also used as agents of abuse and typically inhaled . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Hydrocarbon Toxicity
- What is being tested?
- serum procalcitonin and C-reactive protein
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of both sexes admitted to the Poison control center, Ain Shams university hospitals with acute hydrocarbon toxicity during the duration from December 2023 till December 2024 with a maximum number of 60 cases within 24 hours of intoxication
Who may be able to join
- Patients of both sexes admitted to the Poison control center, Ain Shams university hospitals with acute hydrocarbon toxicity during the duration from December 2023 till December 2024 with a maximum number of 60 cases within 24 hours of intoxication.
Who cannot join
- Patients with these criteria will be excluded:
- Cases > 24 hours of intoxication.
- Cases with occupational exposure to hydrocarbons.
- Pregnant females.
- Any cases received any treatment before arrival to the PCC.
- Cases suffering from cardiac, respiratory, renal, hepatic or haematological disorders.
- Cases presenting with fever.
- Cases with other causes that can increase levels of CRP \& pro-calcitonin as bacterial infection, recent major trauma, major burn ,septic shock and medullary thyroid cancer.
Trial locations and contacts
1 site in 1 country.
Maha A Helal, professor contact
About this study
Hydrocarbons are a primary energy source in modern society. They are present in many common household and occupational products, including motor fuels, paint thinners, cleaning agents, lotions, and industrial solvents. Unfortunately, these products are also used as agents of abuse and typically inhaled .
They are derived mainly from petroleum (kerosene, gas, naphtha) or wood (turpentine, pine oil). They can be found in liquid, gas, or solid form depending on their properties. All hydrocarbons can be toxic, but aromatic (ring-shaped) and halogenated hydrocarbons typically have more severe toxicity .
Toxicity occurs in various ways including through inhalation, ingestion, aspiration, and dermal exposure. Frequently, these exposures occur during attempted recreational use of the substances and sometimes for self-injurious behavior
- Conditions
- Acute Hydrocarbon Toxicity
- Being tested
- serum procalcitonin, C-reactive protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum procalcitoninDiagnostic test
predicting the severity of intoxication
C-reactive proteinDiagnostic test
predicting the severity of intoxication
| Study group | Role | What they receive |
|---|---|---|
| control group | 20 subjects of apparently healthy persons for estimating the standard levels of the tested biomarkers. Receives: Diagnostic Test: serum procalcitonin; Diagnostic Test: C-reactive protein | |
| case group | 60 patients divided into mild, moderate and severe toxicity according to the poisoning severity score. Receives: Diagnostic Test: serum procalcitonin; Diagnostic Test: C-reactive protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum procalcitonin level
measuring the level of serum procalcitonin (reference range 0-0.05µg/L)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hydrocarbon ToxicityStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mera Gergis khalil, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151301
- Sponsor's protocol ID
- Soh-Med-23-11-01MD
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Poisoning Severity Score, Serum Procalcitonin and C-reactive Protein in Acute Hydrocarbon Intoxicated Cases Admitted to the Poison Control Center Ain Shams University Hospitals
- ClinicalTrials.gov ID
- NCT06151301
- Acronym / sponsor ID
- Soh-Med-23-11-01MD
- Conditions
- Acute Hydrocarbon Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Nov 2023 (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.
Hydrocarbons are a primary energy source in modern society. They are present in many common household and occupational products, including motor fuels, paint thinners, cleaning agents, lotions, and industrial solvents. Unfortunately, these products are also used as agents of abuse and typically inhaled .
They are derived mainly from petroleum (kerosene, gas, naphtha) or wood (turpentine, pine oil). They can be found in liquid, gas, or solid form depending on their properties. All hydrocarbons can be toxic, but aromatic (ring-shaped) and halogenated hydrocarbons typically have more severe toxicity .
Toxicity occurs in various ways including through inhalation, ingestion, aspiration, and dermal exposure. Frequently, these exposures occur during attempted recreational use of the substances and sometimes for self-injurious behavior
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: serum procalcitonin, Diagnostic Test: C-reactive protein20 subjects of apparently healthy persons for estimating the standard levels of the tested biomarkers. |
| case group | – | Diagnostic Test: serum procalcitonin, Diagnostic Test: C-reactive protein60 patients divided into mild, moderate and severe toxicity according to the poisoning severity score. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both sexes admitted to the Poison control center, Ain Shams university hospitals with acute hydrocarbon toxicity during the duration from December 2023 till December 2024 with a maximum number of 60 cases within 24 hours of intoxication
Key inclusion criteria (1 listed)
- Patients of both sexes admitted to the Poison control center, Ain Shams university hospitals with acute hydrocarbon toxicity during the duration from December 2023 till December 2024 with a maximum number of 60 cases within 24 hours of intoxication.
Key exclusion criteria (8 listed)
- Cases > 24 hours of intoxication.
- Cases with occupational exposure to hydrocarbons.
- Pregnant females.
- Any cases received any treatment before arrival to the PCC.
- Cases suffering from cardiac, respiratory, renal, hepatic or haematological disorders.
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 |
|---|---|---|
| serum procalcitoninpredicting the severity of intoxication | Diagnostic test | case group, control group |
| C-reactive proteinpredicting the severity of intoxication | Diagnostic test | case group, control group |
Primary outcome
Serum procalcitonin level
Time frame: 1 year
measuring the level of serum procalcitonin (reference range 0-0.05µg/L)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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.
Maha A Helal, professor contact
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 Acute Hydrocarbon Toxicity, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mera G Khalil, assistant lecutrer (01229185948, Mera_Sadek@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum procalcitonin level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.