the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS

NCT03780933 | Completed

• 1 other identifier: 247
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To access role of vitamin C supplementation in ARDS patients on the following:
2. 2.To access tolerability of vitamin C supplementation in patients with ARDS.

Conditions

Acute Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• Assessment of Improvement in ARDS patient's mortality rate

  Days to weaning from ventilator

  within 10 days of ARDS diagnosis

Secondary Outcomes (2)

• Intensive Care Unit Length of Stay

  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

  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

Study Arms (2)

control group

NO INTERVENTION

conventional treatment (corticosteroids, mechanical ventilation)

test group (vitamin C)

EXPERIMENTAL

high dose vitamin c iv infusion

Dietary Supplement: vitamin c

Interventions

vitamin c DIETARY_SUPPLEMENT

vitamin c IV 10 G

test group (vitamin C)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Embaba Chest Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Nada Farrag, Msc

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: December 19, 2018
• Study Start: July 5, 2017
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)