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

This study has been completed.
Sponsor:
Information provided by:
Maulana Azad Medical College
ClinicalTrials.gov Identifier:
NCT00702871
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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

Resource links provided by NLM:


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
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
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
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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

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:
Ulcer
Pneumonia
Disease Susceptibility
Pneumonia, Ventilator-Associated
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Sucralfate
Ranitidine
Ranitidine bismuth citrate
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 September 30, 2014