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the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS

The Impact of High Dose Vitamin C Ascorbic Acid on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03780933
Enrollment
40
Registered
2018-12-19
Start date
2017-07-05
Completion date
2019-06-20
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress

Brief summary

1. To access role of vitamin C supplementation in ARDS patients on the following: Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from mechanical ventilator Incidence of adverse drug reaction 2. To access tolerability of vitamin C supplementation in patients with ARDS.

Detailed description

Acute Respiratory distress syndrome (ARDS) is a form of severe hypoxemic respiratory failure due to severe impairment of gas exchange and lung mechanics that is characterized by inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich edema fluid into the air space. Current ARDS antioxidant treatment strategy, is based upon supportive therapies including low tidal volume ventilation, fluid management, nutritional support and glucocorticoids. Ascorbic acid or Vitamin C is an important dietary water-soluble antioxidant, it significantly decreases the adverse effects of ROS such as reactive oxygen and nitrogen species that can cause oxidative damage to macromolecules. Recent studies show that high dose of Vitamin C have protective effects against overwhelming oxidative stress due to critical illness. Vitamin C improves immune function and improves tissue perfusion and reduce tissue hypoxia and subsequent organ dysfunction. Also, Ascorbate, the redox form of vitamin C is physiological antioxidant and has bacteriostatic activity Hence the study aims to evaluate the impact of IV Vitamin C in ARDS, as a novel pharmaceutical approach in an attempt to improve the clinical outcome of ARDS patients, decrease other medications toxicities and improve patients' quality of life. The objective of the current study was to evaluate the efficacy, safety and tolerability of IV Vitamin C administration in addition to conventional therapy in patients with ARDS by assessing the following: 1. Oxidants/ antioxidants imbalance 2. Length of hospital stay 3. Mortality rate 4. Weaning from mechanical ventilator 5. Incidence of adverse drug reaction 6. Serum IL8 levels 8\. Serum Vitamin C levels

Interventions

DIETARY_SUPPLEMENTvitamin c

vitamin c IV 10 G

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis 2. who don't have an

Exclusion criteria

will be included.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Improvement in ARDS patient's mortality ratewithin 10 days of ARDS diagnosisDays to weaning from ventilator

Secondary

MeasureTime frameDescription
Intensive Care Unit Length of Staysubject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is firstimprovement in clinical outcome
Duration of Mechanical Ventilationsubject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 10 days from time of enrollment, whichever is firstimprovement in respiratory functions

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026