Clinical trial NCT03780933: the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS
Official title: The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Assessment of Improvement in ARDS patient's mortality rate
timeFrame: within 10 days of ARDS diagnosis
Secondary outcomes:
measure: Intensive Care Unit Length of Stay
timeFrame: subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first
measure: Duration of Mechanical Ventilation
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Embaba Chest Hospitals
Study officials:
affiliation: Misr International University
name: Nada Farrag, Msc
role: PRINCIPAL_INVESTIGATOR
References: