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OpenTrials
Completed

NCT Number: NCT03780933

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Embaba Chest Hospitals

Cairo, Egypt

About this study

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:

  • Oxidants/ antioxidants imbalance
  • Length of hospital stay
  • Mortality rate
  • Weaning from mechanical ventilator
  • Incidence of adverse drug reaction
  • Serum IL8 levels
  • Serum Vitamin C levels

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis
  • who don't have an exclusion criteria will be included.

Exclusion criteria

  • Known allergy to Vitamin C
  • Inability to obtain consent;
  • Age < 18 years;
  • More than 48 hours since meeting ARDS criteria;
  • Pregnancy or breast feeding,
  • Moribund patient not expected to survive 24 hours;
  • Patients not eligible to CPR
  • Active kidney stone

Treatment and study plan

Vitamin C

Dietary Supplement

vitamin c IV 10 G

Primary outcomes

  1. Assessment of Improvement in ARDS patient's mortality rate

    Time frame: within 10 days of ARDS diagnosis

    Days to weaning from ventilator

Secondary outcomes

  1. Intensive Care Unit Length of Stay

    Time frame: subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first

    improvement in clinical outcome

  2. Duration of Mechanical Ventilation

    Time frame: subject 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 first

    improvement in respiratory functions

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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