Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:06 PM
Study NCT ID:
NCT03780933
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS
Sponsor:
Misr International University
Organization:
Study Overview
Official Title:
The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: