Acute PoisoningNCT05185570
Prognosis of Elderly Patients With Acute Poisoning.
An observational study of Acute Poisoning, run by Sohag University.
Trial summary
Acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. It primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Poisoning
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Oct 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly patients with acute poisoning.
Who may be able to join
- all patients more than 60 years will be included.
Who cannot join
- younger than 60 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Risk Factors Influencing the Prognosis of Elderly Patients With Acute Poisoning.
Acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. It primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. More than half of the intoxication events in the elderly over 65 years old were accidental.
Read the detailed description
The elderly are different from younger adults in many aspects. There are age related physiological changes. They have a higher incidence of comorbidities and use of many medications for chronic conditions, both of which make the elderly more susceptible to acute poisoning and its related consequences.
Although the elderly form a relatively small proportion of those admitted to hospital for acute self-poisoning, the poisoning in them is often more serious, complications are more frequent and a fatal outcome is more common.
The presence of multiple physical, social, and psychiatric problems, with possible difficulties in the diagnosis of poisoning make the management of the elderly more complicated than that of younger poisoned patients. There are three main difficulties in diagnosing acute poisoning in the elderly. At first, it may not be easily obvious that the patient has taken an overdose. Secondly, the presence of pre-existing diseases may obscure the clinical picture and finally, the drug may cause physical signs that similar to common problems of old age.
- Conditions
- Acute Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acute physiology and chronic health evaluation II score (APACHE II) in cases of elderly patients with acute poisoning.
"Acute Physiology And Chronic Health Evaluation II(APACHE II) " is a severity-of-disease classification system. one of several ICU scoring systems. It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.
Measured: 24 hours after admission to intensive care unit (ICU).
Change in Poisoning Severity Score (PSS) in cases of elderly patients with acute poisoning.
"Poisoning Severity Score (PSS)" is a standardized scale for grading the severity of poisoning allows qualitative evaluation of. morbidity caused by poisoning, better identification of real risks and comparability of data.
Measured: 24 hours after admission to intensive care unit (ICU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PoisoningStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer hussien Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185570
- Sponsor's protocol ID
- Soh-Med-21-12-01
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk Factors Influencing the Prognosis of Elderly Patients With Acute Poisoning.
- ClinicalTrials.gov ID
- NCT05185570
- Acronym / sponsor ID
- Soh-Med-21-12-01
- Conditions
- Acute Poisoning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. It primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. More than half of the intoxication events in the elderly over 65 years old were accidental.
Detailed description
The elderly are different from younger adults in many aspects. There are age related physiological changes. They have a higher incidence of comorbidities and use of many medications for chronic conditions, both of which make the elderly more susceptible to acute poisoning and its related consequences.
Although the elderly form a relatively small proportion of those admitted to hospital for acute self-poisoning, the poisoning in them is often more serious, complications are more frequent and a fatal outcome is more common.
The presence of multiple physical, social, and psychiatric problems, with possible difficulties in the diagnosis of poisoning make the management of the elderly more complicated than that of younger poisoned patients. There are three main difficulties in diagnosing acute poisoning in the elderly. At first, it may not be easily obvious that the patient has taken an overdose. Secondly, the presence of pre-existing diseases may obscure the clinical picture and finally, the drug may cause physical signs that similar to common problems of old age.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients with acute poisoning.
Key inclusion criteria (1 listed)
- all patients more than 60 years will be included.
Key exclusion criteria (1 listed)
- younger than 60 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Acute physiology and chronic health evaluation II score (APACHE II) in cases of elderly patients with acute poisoning.
Time frame: 24 hours after admission to intensive care unit (ICU).
"Acute Physiology And Chronic Health Evaluation II(APACHE II) " is a severity-of-disease classification system. one of several ICU scoring systems. It is applied within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.
Change in Poisoning Severity Score (PSS) in cases of elderly patients with acute poisoning.
Time frame: 24 hours after admission to intensive care unit (ICU).
"Poisoning Severity Score (PSS)" is a standardized scale for grading the severity of poisoning allows qualitative evaluation of. morbidity caused by poisoning, better identification of real risks and comparability of data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Poisoning, run by Sohag University.
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 1 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Abeer H Mohammed (01019585267, abeer011116@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acute physiology and chronic health evaluation II score (APACHE II) in cases of elderly patients with acute poisoning. (time frame: 24 hours after admission to intensive care unit (ICU).). The study lists 2 primary outcomes in all. 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 19 Jan 2022.