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Sponsored by: |
Maulana Azad Medical College |
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Information provided by: | Maulana Azad Medical College |
ClinicalTrials.gov Identifier: | NCT00702871 |
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 |
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Ventilator Associated Pneumonia Etiological Organisms Antimicrobial Drug Susceptibility Pattern Stress Ulcer Prophylaxis |
Drug: Ranitidine Drug: Sucralfate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study |
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 |
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1: Active Comparator
Arm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis.
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Drug: Ranitidine
In arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay.
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2: Active Comparator
In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
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Drug: Sucralfate
In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
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Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India ( Dr Mradul K Daga ) |
Study ID Numbers: | 403(7)/04MC(ACA)/Protocol/3499 |
Study First Received: | June 19, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00702871 |
Health Authority: | India: Institutional Review Board |
Ventilator Associated Pneumonia antimicrobial susceptibility pattern stress ulcer prophylaxis |
Sucralfate Disease Susceptibility Gastrointestinal Diseases Ulcer Stress Intestinal Diseases Pneumonia, Ventilator-Associated Histamine Duodenal Ulcer Ranitidine Digestive System Diseases |
Ranitidine bismuth citrate Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Histamine phosphate Genetic Predisposition to Disease Cross Infection Pneumonia Peptic Ulcer Duodenal Diseases |
Disease Attributes Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Histamine Agents Infection |
Pharmacologic Actions Histamine H2 Antagonists Pathologic Processes Histamine Antagonists Therapeutic Uses Anti-Ulcer Agents |