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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702871
First Posted: June 20, 2008
Last Update Posted: June 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maulana Azad Medical College
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: June 20, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Ulcer
Pneumonia
Disease Susceptibility
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Ranitidine
Ranitidine bismuth citrate
Sucralfate
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs