Mechanical Ventilation DurationNCT05274503
Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
An observational study of Mechanical Ventilation Duration, run by Sohag University at 1 site in Egypt.
Trial summary
Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is <10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mechanical Ventilation Duration
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 2022
- How long will I take part?
- 6 Months
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: patients more than 20 years old, covid positive, mechanically ventilated
Who may be able to join
- •Age: more than 20 years.
- Gender: both males and females will be included.
- Mechanically Ventilated patients.
- COVID 19 confirmed diagnosis
Who cannot join
- •Immunocompromised patients.
- Oxygen saturation more than 95% without ventilation.
- Malignancy.
- Patients refuse to be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is <10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition
- Conditions
- Mechanical Ventilation Duration
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of acute respiratory distress syndrome
hypoxia, incresed plateau pressure
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation DurationStudies 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
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274503
- Sponsor's protocol ID
- soh-Med-22-1-27
- Status last verified
- Feb 2022
- First submitted
- 9 Mar 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
- ClinicalTrials.gov ID
- NCT05274503
- Acronym / sponsor ID
- soh-Med-22-1-27
- Conditions
- Mechanical Ventilation Duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Mar 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.
Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is <10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients more than 20 years old, covid positive, mechanically ventilated
Key inclusion criteria (4 listed)
- •Age: more than 20 years.
Key exclusion criteria (4 listed)
- •Immunocompromised patients.
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
detection of acute respiratory distress syndrome
Time frame: 2 weeks
hypoxia, incresed plateau pressure
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 10 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation Duration, 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 4 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 10 Mar 2022. 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?
detection of acute respiratory distress syndrome (time frame: 2 weeks). 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 10 Mar 2022.