Clinical Trials Directory

Trials / Completed

CompletedNCT03780933

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Misr International University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTvitamin cvitamin c IV 10 G

Timeline

Start date
2017-07-05
Primary completion
2019-06-20
Completion
2019-06-20
First posted
2018-12-19
Last updated
2019-10-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03780933. Inclusion in this directory is not an endorsement.