Critical IllnessCOVID-19NCT05279469
D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients
An observational study of Critical Illness and Pneumonia, Viral, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Pneumonia, Viral
- How many people
- 465 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Jun 2021to 9 Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy
Who may be able to join
- patients of both sex admitted in icu
- positive PCR
- requiring oxygen therapy
Who cannot join
- ward patients
- negative PCR
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams university hospitals
Cairo
Faculty of medicine, Ain Shams University
Cairo
About this study
Official title: D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in SARS-COV-2 Patients: A Retrospective Study
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.
Read the detailed description
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.
It has been reported that COVID 19 is associated with hemostatic abnormalities and elevated D-Dimer level, so its level is used to predict severity of disease.
- Conditions
- Critical Illness, Pneumonia, Viral
- Being tested
- no intervention, just observational for D-Dimer level in blood
- Keywords
- D dimer, SARS-COV-2
- Medical subject headings
- Critical Illness, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, just observational for D-Dimer level in bloodOther
observation for basal D-Dimer and 48 hours later D-Dimer in blood for ICU SARS.COV.2 patients
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days mortality
Outcomes of ICU stay
Measured: 1 month
Secondary outcomes (1)
length of stay and mechanical ventilation
time of admission and need to escalate oxygen therapy
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start10 Jun 2021
- Primary completion3 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Retrospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M Hilal Abdou, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279469
- Sponsor's protocol ID
- MS56/2022
- Acronym
- COVID-19
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in SARS-COV-2 Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05279469
- Acronym / sponsor ID
- COVID-19 / MS56/2022
- Conditions
- Critical Illness, Pneumonia, Viral
- Keywords
- D dimer, SARS-COV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 15 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.
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.
Detailed description
Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.
It has been reported that COVID 19 is associated with hemostatic abnormalities and elevated D-Dimer level, so its level is used to predict severity of disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy
Key inclusion criteria (3 listed)
- patients of both sex admitted in icu
- positive PCR
- requiring oxygen therapy
Key exclusion criteria (2 listed)
- ward patients
- negative PCR
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 |
|---|---|---|
| no intervention, just observational for D-Dimer level in bloodobservation for basal D-Dimer and 48 hours later D-Dimer in blood for ICU SARS.COV.2 patients | Other | – |
Primary outcome
28 days mortality
Time frame: 1 month
Outcomes of ICU stay
1 secondary outcome
length of stay and mechanical ventilation
Time frame: during ICU stay
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 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Pneumonia, Viral, run by Ain Shams University at 2 sites 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 3 inclusion and 2 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 15 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 2 sites 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?
28 days mortality (time frame: 1 month). 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 15 Mar 2022.