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ARDSNCT04411160

Vitamin C Versus Nitric Oxide in Prolonged Ventilation

An observational study of ARDS, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This a prospective double-blind study done in King Abdul-Aziz specialist hospital between January 2019 and April 2020 in the intensive care unit on 60 patients with difficult weaning and ventilated for 10 days. Allocated randomly in two groups 30 patients in each. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
ARDS
What is being tested?
Vitamin C, Nitric Oxide and ventilators
How many people
60 participants
Where
1 siteSaudi Arabia
Study dates
15 Jan 2019to 21 Apr 2020
Phase
Observational
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This a prospective cohort study done in King Abd el Aziz specialist hospital between January 2019 and April 2020 in the intensive care unit on 60 patients with respiratory failure and showed failure of weaning from ventilator either due to medical or surgical causes. King Abdelaziz research and ethical committee approved the project.

Who may be able to join

  • ARDS

Who cannot join

  • systemic disease as diabetes and hypertension

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • King abd el Aziz specialist hospital

    Ta'if, 21944

Other trials in Saudi Arabia

About this study

Official title: Comparative Study Between the Effect of Vitamin C vs. Nitric Oxide in Weaning of Patients With Prolonged Ventilation Due to ARDS

This a prospective double-blind study done in King Abdul-Aziz specialist hospital between January 2019 and April 2020 in the intensive care unit on 60 patients with difficult weaning and ventilated for 10 days. Allocated randomly in two groups 30 patients in each. All patients in both groups continued on the same conventional ventilation but Group A received nitric oxide (NO) while group B received vitamin C intravenous. The duration of the study last 16 days. during this period, APCHII score, Hemodynamics, Chest Xray, hypoxic index, lung compliance, Recruitment maneuver, arterial blood saturation, LDH, C-reactive protein used as indicator for improvement. Number of patients weaned from the ventilator and patients died also recorded.

Read the detailed description

All selected patients received conventional ventilation with protective lung strategy for 10 days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial oxygen saturation(SPO2) of 90% or more with sedation by midazolam infusion to achieve Richmond Agitation- Sedation Scale (RASS) -2 to -3 and fentanyl infusion for pain control between 50-100 mg/min. Protective lung strategy was strictly applied in form of head elevation more than 30°, broad spectrum antibiotics according to our antibiotic regimen, daily assessment for both analgesic and sedative dose were given to patients, early naso-gastric feeding started to prevent ventilator associated pneumonia and daily trial was done to reduce PEEP to prevent more lung injury from ventilation also qualitative sputum culture was taken after one week from ventilation. After 10 days from the conventional ventilation those who could not be weaned from the ventilator and still had the former criteria mentioned before (Uncompensated hypercapnia with PH<7.25, and/or Hypoxic index less than 200) included in our study. Percutaneous dilatation tracheostomy done for all patients in both groups. 60 patients randomly allocated in 2 groups. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time. Each group included 30 patients. Patients of group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose. While patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days duration. Improvement of general condition of the patients monitored in our study by APACH II score and core body temperature. improvement of the lungs condition monitored in our study clinically by monitoring: oxygen saturation, hypoxic index, compliance and response to recruitment maneuver ( Recruitment maneuver is considered clinical test of lung compliance and start by increase the peak inspiratory pressure to 40 cm/H2O for 40 sec and observe the saturation (SpO2) if improved to more than 95% considered responder in our study).(18) and radiologically by size of parenchymatous lung infiltration on chest X ray. The duration of the study 16 days

Conditions
ARDS
Being tested
Vitamin C, Nitric Oxide, ventilators

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDrug

    4 gram of vitamin c slowly intravenous once daily for 4 days duration.

  • Nitric OxideDrug

    nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose

  • ventilatorsDevice

    All selected patients received conventional ventilation with protective lung strategy for 10 days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial oxygen saturation(SPO2) of 90%

Study groups in NCT04411160
Study groupRoleWhat they receive
Group APatients of group A received inhalation of nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose.
Receives: Drug: Nitric Oxide; Device: ventilators
Group BWhile patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days duration.
Receives: Drug: Vitamin C; Device: ventilators

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tissue oxygenation

    observe the arterial oxygen saturation SpO2

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start15 Jan 2019
  3. Primary completion19 Apr 2020
  4. Study completion21 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04411160
Sponsor's protocol ID
ICU-32-20
Status last verified
Jun 2020
First submitted
21 May 2020
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.

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 1 inclusion and 1 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 9 Jun 2020. 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 Saudi Arabia. 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?

tissue oxygenation (time frame: 2 weeks). 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 9 Jun 2020.

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