Drug InteractionNCT04078620
Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.
An observational study of Drug Interaction, run by Zagazig University at 1 site in Egypt.
Trial summary
Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Survey for drug drug interactions on medscape and lexicomp applications
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2018to 20 Apr 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients admitted to Surgical ICUs, zagazig University Hospital
Who may be able to join
- all patients admitted to Surgical ICUs for six months period
Who cannot join
- less than one day admission to ICU,not completed data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals
Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay
Read the detailed description
This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period.
Demographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness
- Conditions
- Drug Interaction
- Being tested
- Survey for drug drug interactions on medscape and lexicomp applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey for drug drug interactions on medscape and lexicomp applicationsDiagnostic test
Survey for drug drug interactions on Medscape and Lexicomp interaction checker applications
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Drug interactions by Lexicomp interactions application
Lexicomp interactions classified As:
A(no known interactions) B(no action needed) C(monitor therapy) D(consider therapy modification) X (avoid combination)
Measured: 6months period
Severity of Drug interactions by Medescape interactions checker:
Interactions classified with Medescape interactions checker as :(contraindicated, serious use alternative, monitor closely,minor)
Measured: 6months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Jun 2018
- Primary completion15 Jan 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liza Elsayed Ali soliman shallouf, Zagazig University
- Investigators
- Liza Shallouf, Principal investigator, Zagazig UniversityHeba Matar, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078620
- Sponsor's protocol ID
- 4606/28-5-2018
- Status last verified
- Aug 2019
- First submitted
- 25 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data could be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals
- ClinicalTrials.gov ID
- NCT04078620
- Acronym / sponsor ID
- 4606/28-5-2018
- Conditions
- Drug Interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 6 Sep 2019 (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.
Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay
Detailed description
This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period.
Demographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to Surgical ICUs, zagazig University Hospital
Key inclusion criteria (1 listed)
- all patients admitted to Surgical ICUs for six months period
Key exclusion criteria (1 listed)
- less than one day admission to ICU,not completed data
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 |
|---|---|---|
| Survey for drug drug interactions on medscape and lexicomp applicationsSurvey for drug drug interactions on Medscape and Lexicomp interaction checker applications | Diagnostic test | – |
Primary outcome
Severity of Drug interactions by Lexicomp interactions application
Time frame: 6months period
Lexicomp interactions classified As: A(no known interactions) B(no action needed) C(monitor therapy) D(consider therapy modification) X (avoid combination)
Severity of Drug interactions by Medescape interactions checker:
Time frame: 6months period
Interactions classified with Medescape interactions checker as :(contraindicated, serious use alternative, monitor closely,minor)
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 6 Sep 2019.
- Individual participant dataSharing planned: Yes. All data could be shared
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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.
Liza Shallouf principal investigator
Zagazig University
Heba Matar study director
Zagazig University
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 Drug Interaction, run by Zagazig 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 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: finished, as of the sponsor's last update on 6 Sep 2019. 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?
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?
Severity of Drug interactions by Lexicomp interactions application (time frame: 6months period). 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 6 Sep 2019.