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Search / Trial NCT04153487

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

Transfusion Reaction Transfusion Related Complication Acute Lung Injury Critical Care

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.

Locations

Beheira, , Egypt

Patients applied

0 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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