A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia

NCT00702871 | Completed Phase 4

• 1 other identifier: 403(7)/04MC(ACA)/Protocol/3499
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of this study was to determine incidence, risk factors, etiological micro-organisms and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on occurrence of VAP. Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility pattern. Patients were divided into 2 groups on random basis. The first group was given ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter, difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate) and on occurrence of VAP in both the groups was compared. Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in developing countries like India. This data is crucial for providing information for deciding future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric colonization by pathogenic organism and increase incidence of Ventilator associated pneumonia; patients were divided into two groups on random basis, as described above.

Conditions

Ventilator Associated Pneumonia; Etiological Organisms; Antimicrobial Drug Susceptibility Pattern; Stress Ulcer Prophylaxis

Keywords

Ventilator Associated Pneumonia; antimicrobial susceptibility pattern; stress ulcer prophylaxis

Outcome Measures

Primary Outcomes (1)

• Occurence of ventilator associated pneumonia

  till discharge from ICU or death of Patient

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis.

Drug: Ranitidine

2

ACTIVE COMPARATOR

In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay

Drug: Sucralfate

Interventions

Ranitidine DRUG

In arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay.

1

Sucralfate DRUG

In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay

2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 12 years
• Those on mechanical ventilation for more than 48 hours.

You may not qualify if:

• Pre-existing pneumonia at the beginning of ventilation or
• Developing pneumonia within 48 hours of ventilation.
• Patients on oral antibiotics

Sponsors & Collaborators

• Maulana Azad Medical College: lead

Study Sites (1)

Maulana Azad Medical College and Lok Nayak Hospital

Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Ranitidine; Sucralfate

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Rajiv Singla, M.D.

  Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: March 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: June 20, 2008

Record last verified: 2008-06

Locations

IN (1)