A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventilator Associated Pneumonia Etiological Organisms Antimicrobial Drug Susceptibility Pattern Stress Ulcer Prophylaxis |
Drug: Ranitidine Drug: Sucralfate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study |
- Occurence of ventilator associated pneumonia [ Time Frame: till discharge from ICU or death of Patient ] [ Designated as safety issue: Yes ]
| Enrollment: | 50 |
| Study Start Date: | March 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Arm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis.
|
Drug: Ranitidine
In arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay.
|
|
Active Comparator: 2
In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
|
Drug: Sucralfate
In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 12 years
- Those on mechanical ventilation for more than 48 hours.
Exclusion Criteria:
- Pre-existing pneumonia at the beginning of ventilation or
- Developing pneumonia within 48 hours of ventilation.
- Patients on oral antibiotics
Contacts and Locations| India | |
| Maulana Azad Medical College and Lok Nayak Hospital | |
| Delhi, India, 110002 | |
| Principal Investigator: | Rajiv Singla, M.D. | Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India |
More Information
No publications provided
| Responsible Party: | Dr Mradul K Daga, Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India |
| ClinicalTrials.gov Identifier: | NCT00702871 History of Changes |
| Other Study ID Numbers: | 403(7)/04MC(ACA)/Protocol/3499 |
| Study First Received: | June 19, 2008 |
| Last Updated: | June 19, 2008 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Maulana Azad Medical College:
|
Ventilator Associated Pneumonia antimicrobial susceptibility pattern stress ulcer prophylaxis |
Additional relevant MeSH terms:
|
Pneumonia, Ventilator-Associated Ventilator-Induced Lung Injury Disease Susceptibility Genetic Predisposition to Disease Pneumonia Ulcer Disease Attributes Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cross Infection Infection Lung Injury |
Ranitidine Ranitidine bismuth citrate Sucralfate Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013