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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress
• Intervention / Treatment: Dietary supplement: vitamin c

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Embaba Chest Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

1. Known allergy to Vitamin C
2. Inability to obtain consent;
3. Age < 18 years;
4. More than 48 hours since meeting ARDS criteria;
5. Pregnancy or breast feeding,
6. Moribund patient not expected to survive 24 hours;
7. Patients not eligible to CPR
8. Active kidney stone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; conventional treatment (corticosteroids, mechanical ventilation)
Experimental: test group (vitamin C); high dose vitamin c iv infusion	Dietary supplement: vitamin c; vitamin c IV 10 G

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Improvement in ARDS patient's mortality rate	Days to weaning from ventilator	within 10 days of ARDS diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit Length of Stay	improvement in clinical outcome	subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first
Duration of Mechanical Ventilation	improvement in respiratory functions	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

Collaborators and Investigators

• Sponsor: Misr International University
• Investigators: Principal Investigator: Nada Farrag, Msc, Misr International University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No