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A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia
This study has been completed.
Sponsored by: Maulana Azad Medical College
Information provided by: Maulana Azad Medical College
ClinicalTrials.gov Identifier: NCT00702871
  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 IV

MedlinePlus related topics: Pneumonia
Drug Information available for: Ranitidine Ranitidine Hydrochloride Ranitidine bismuth citrate Sucralfate
U.S. FDA Resources
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

Further study details as provided by Maulana Azad Medical College:

Primary Outcome Measures:
  • 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
1: Active Comparator
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.
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
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702871

Locations
India
Maulana Azad Medical College and Lok Nayak Hospital
Delhi, India, 110002
Sponsors and Collaborators
Maulana Azad Medical College
Investigators
Principal Investigator: Rajiv Singla, M.D. Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India
  More Information

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

Keywords provided by Maulana Azad Medical College:
Ventilator Associated Pneumonia
antimicrobial susceptibility pattern
stress ulcer prophylaxis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009