- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279469
D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients (COVID-19)
March 12, 2022 updated by: Amr M Hilal Abdou, Ain Shams University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
465
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Medicine, Ain Shams University
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Cairo, Egypt
- Ain shams university hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy
Description
Inclusion Criteria:
- patients of both sex admitted in icu
- positive PCR
- requiring oxygen therapy
Exclusion Criteria:
- ward patients
- negative PCR
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
28 days mortality
Time Frame: 1 month
|
Outcomes of ICU stay
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of stay and mechanical ventilation
Time Frame: during ICU stay
|
time of admission and need to escalate oxygen therapy
|
during ICU stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2021
Primary Completion (Actual)
March 3, 2022
Study Completion (Actual)
March 9, 2022
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
March 12, 2022
First Posted (Actual)
March 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2022
Last Update Submitted That Met QC Criteria
March 12, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Critical Illness
- Pneumonia, Viral
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Fibrin fragment D
Other Study ID Numbers
- MS56/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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