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

NCT ID: NCT03780933

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2019-06-20

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

Conditions

Acute Respiratory Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

conventional treatment (corticosteroids, mechanical ventilation)

Group Type: NO_INTERVENTION

No interventions assigned to this group

test group (vitamin C)

high dose vitamin c iv infusion

Group Type: EXPERIMENTAL

vitamin c

Intervention Type: DIETARY_SUPPLEMENT

vitamin c IV 10 G

Interventions

vitamin c

vitamin c IV 10 G

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Misr International University

OTHER

Sponsor Role: lead

Responsible Party

Nada Hazem Farrag

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nada Farrag, Msc

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

Embaba Chest Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

247

Identifier Type: -

Identifier Source: org_study_id