Role of Ascorbic Acid Infusion in Critically Ill Patients With Transfusion Related Acute Lung Injury
Launched by DAMANHOUR UNIVERSITY · Nov 5, 2019
Trial Information
Current as of May 24, 2025
Completed
Keywords
ClinConnect Summary
1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
2. The minimum required sample size is estimated to be 40 patients for each group.
3. Full written informed consent will be taken from all patients or their next of kin to participate in this study.
4. All patients will be subjected directly at time of enrollment to the following;
* Complete history taking and demographic data
* The potential recipient risk factors for TRALI.
* The initial cause of ICU admission and the blood products received.
* Complete physical ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult (18 - 64 years) critically ill patients diagnosed with transfusion related acute lung injury (TRALI), at the time of enrollment or maximum 6 hours before, according to the National Heart, Lung and Blood Institute (NHLBI) Working Group definitions and or the Canadian Consensus Conference criteria (29, 30) as the following criteria;
- • No evidence of ALI prior to transfusion.
- • Onset of ALI ≤ 6 hours following cessation of transfusion.
- • Hypoxemia, defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or oxygen saturation ≤ 90% on room air.
- • Radiographic evidence of bilateral infiltrates.
- • No evidence of left atrial hypertension.
- Exclusion Criteria:
- • Pregnancy or breastfeeding.
- • Hypernatremia or known hypersensitivity to the study drug.
- • Parenteral nutrition (total/partial) containing vitamin C.
- • Active renal stone or history of urolithiasis.
- • Acute Kidney Injury.
- • Glucose 6 phosphate dehydrogenase deficiency, iron and copper storage diseases.
- • Immunocompromised patients (cancer or patients on immunosuppressive drugs).
- • Moribund patient not expected to survive 24 hours .
- • Home mechanical ventilation (via tracheotomy or noninvasive) except for Continuous Positive Airway Pressure/ Bilevel Positive Airway Pressure (CPAP/BIPAP) used only for sleep-disordered breathing .
About Damanhour University
Damanhour University is a prominent academic institution in Egypt, dedicated to advancing healthcare and medical research through innovative clinical trials. With a commitment to improving patient outcomes and fostering scientific discovery, the university collaborates with healthcare professionals and researchers to conduct rigorous studies that address critical health challenges. By leveraging its state-of-the-art facilities and expertise, Damanhour University aims to contribute significantly to the body of medical knowledge and enhance the quality of care provided to diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beheira, , Egypt
Patients applied
Trial Officials
Gamal A Omran, PHD
Study Director
Professor of Biochemistry, Damanhour University.
Mohamed M Megahed, MD
Study Director
Professor of Critical Care Medicine, Alexandria University.
Tamer N Zakhary, MD
Study Chair
Ass. Professor of Critical Care Medicine, Alexandria University.
Amira B Kassem, PHD
Study Chair
Lecturer of Clinical Pharmacy, Damanhour University.
Islam E Ahmed, PharmD
Principal Investigator
Clinical Pharmacy Specialist, Damanhour University.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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