Vitamin C Versus Nitric Oxide in Prolonged Ventilation

NCT04411160 | Completed DMC FDA Drug

• 1 other identifier: ICU-32-20
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

• tissue oxygenation

  observe the arterial oxygen saturation SpO2

  2 weeks

Study Arms (2)

Group A

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.

Drug: Nitric Oxide; Device: ventilators

Group B

While patients of group B received 4 gram of vitamin c slowly intravenous once daily for 4 days duration.

Drug: Vitamin C; Device: ventilators

Interventions

Vitamin C DRUG

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

Group B

Nitric Oxide DRUG

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

Group A

ventilators DEVICE

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%

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: adult only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• ARDS

You may not qualify if:

• systemic disease as diabetes and hypertension

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Interventions

Ascorbic Acid; Nitric Oxide; Ventilators, Mechanical

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 2, 2020
• Study Start: January 15, 2019
• Primary Completion: April 19, 2020
• Study Completion: April 21, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)