Acute Respiratory DistressNCT03780933
the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS
A study testing vitamin c in people with Acute Respiratory Distress, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Distress
- What is being tested?
- vitamin c
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2017to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis
- who don't have an exclusion criteria will be included.
Who cannot join
- Known allergy to Vitamin C
- Inability to obtain consent;
- Age < 18 years;
- More than 48 hours since meeting ARDS criteria;
- Pregnancy or breast feeding,
- Moribund patient not expected to survive 24 hours;
- Patients not eligible to CPR
- Active kidney stone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
- 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
- To access tolerability of vitamin C supplementation in patients with ARDS.
Read the 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:
- Oxidants/ antioxidants imbalance
- Length of hospital stay
- Mortality rate
- Weaning from mechanical ventilator
- Incidence of adverse drug reaction
- Serum IL8 levels
- Serum Vitamin C levels
- Conditions
- Acute Respiratory Distress
- Being tested
- vitamin c
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin cDietary supplement
vitamin c IV 10 G
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | conventional treatment (corticosteroids, mechanical ventilation) |
| test group (vitamin C) | Experimental | high dose vitamin c iv infusion Receives: Dietary Supplement: vitamin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Improvement in ARDS patient's mortality rate
Days to weaning from ventilator
Measured: within 10 days of ARDS diagnosis
Secondary outcomes (2)
Intensive Care Unit Length of Stay
improvement in clinical outcome
Measured: subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first
Duration of Mechanical Ventilation
improvement in respiratory functions
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Jul 2017
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Hazem Farrag, Misr International University
- Investigators
- Nada Farrag, Msc, Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780933
- Sponsor's protocol ID
- 247
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Dose Vitamin C "Ascorbic Acid" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03780933
- Acronym / sponsor ID
- 247
- Conditions
- Acute Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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:
- Oxidants/ antioxidants imbalance
- Length of hospital stay
- Mortality rate
- Weaning from mechanical ventilator
- Incidence of adverse drug reaction
- Serum IL8 levels
- Serum Vitamin C levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –conventional treatment (corticosteroids, mechanical ventilation) |
| test group (vitamin C) | Experimental | Dietary Supplement: vitamin chigh dose vitamin c iv infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis
- who don't have an exclusion criteria will be included.
Key exclusion criteria (8 listed)
- Known allergy to Vitamin C
- Inability to obtain consent;
- Age < 18 years;
- More than 48 hours since meeting ARDS criteria;
- Pregnancy or breast feeding,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin cvitamin c IV 10 G | Dietary supplement | test group (vitamin C) |
Primary outcome
Assessment of Improvement in ARDS patient's mortality rate
Time frame: within 10 days of ARDS diagnosis
Days to weaning from ventilator
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Farrag, Msc principal investigator
Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin c in people with Acute Respiratory Distress, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Improvement in ARDS patient's mortality rate (time frame: within 10 days of ARDS diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.