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

• ClinicalTrials.gov Identifier: NCT03780933
• Recruitment Status: Completed
• First Posted: December 19, 2018
• Last Update Posted: October 2, 2019
• Sponsor: Misr International University
• Information provided by (Responsible Party): Nada Hazem Farrag, Misr International University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Distress	Dietary Supplement: vitamin c	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
• Actual Study Start Date: July 5, 2017
• Actual Primary Completion Date: June 20, 2019
• Actual Study Completion Date: June 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Assessment of Improvement in ARDS patient's mortality rate [ Time Frame: within 10 days of ARDS diagnosis ]
   Days to weaning from ventilator

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Embaba Chest Hospitals

Cairo, Egypt

Sponsors and Collaborators

Misr International University

Investigators

• Principal Investigator: Nada Farrag, Msc; Misr International University

More Information

• Responsible Party: Nada Hazem Farrag, Assistant Lecturer, Misr International University
• ClinicalTrials.gov Identifier: NCT03780933
• Other Study ID Numbers: 247
• First Posted: December 19, 2018
• Last Update Posted: October 2, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ascorbic Acid; Vitamins; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents