To test the effectiveness of Vitamin C to decrease pneumonia in mechanically ventilated patients

Phase 1

Not yet recruiting

• Conditions: Bacterial and viral infectious agents, (2) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents,

• Registration Number: CTRI/2018/12/016634
• Lead Sponsor: St Stephens Hospital

Brief Summary

Aim of the study is toexamine the usefulness of Vitamin C to reduce incidence of Ventilatorassociated pneumonia in patients admitted to Pediatric HDUat St. Stephen’s Hospital. The time to development of polymorphic cell reactionand time to development of VAP will be examined in both test and controlgroups. Also duration of ventilation and hospitalization will be recorded. As there has been no previous study ofuse of vitamin C as a mucolytic in ventilated patients, we propose to do apilot study taking a sample size of 40 patients of which 20 will be cases and20 controls. The effect size and variance in this group will be studied to helpin sample size calculations for a definitive study if this sample size provedinadequate. Thepatient randomised to receive vitamin C will be the test group. The other groupreceiving standard care will be controls. Prophylactic doses of vitamin C at adose of 40 mg per kg will be given to the cases from the time of intubation andcomparisons will be made  to the controlgroup receiving standard therapy.ETsecretions will be examined every day looking for polymorphonuclear cells onmicroscopy. Secretions with raised counts will be sent for microbiologicalevaluation – staining for bacteria and for culture of organisms.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-11-12
• Study Start: 2018-12-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All patients ventilated on day 1 of hospitalisation.

Exclusion Criteria

All patients ventilated in other hospital and then referred.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the usefulness of Vitamin C to reduce incidence of Ventilator associated pneumonia.	The time to development of polymorphic cell reaction and time to development of CDC criteria for VAP will be examined in both case and control groups

Secondary Outcome Measures

Name	Time	Method
Duration of ventilation and hospitalization will be recorded.	Duration of ventilation and hospitalization

Trial Locations

Locations (1)

ST. STEPHENS HOSPITAL; 🇮🇳 North, DELHI, India

ST. STEPHENS HOSPITAL

🇮🇳North, DELHI, India

DR CHINMAYA JOSHI

Principal investigator

8929342448

chinmayajoshi1@gmail.com