Ventilator Associated PneumoniaPhase 4NCT00702871
A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia
A Phase 4 study testing Ranitidine and Sucralfate in people with Ventilator Associated Pneumonia and Etiological Organisms, run by Maulana Azad Medical College at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Etiological Organisms, Antimicrobial Drug Susceptibility Pattern
- What is being tested?
- Ranitidine and Sucralfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2005to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than 12 years
- Those on mechanical ventilation for more than 48 hours.
Who cannot join
- Pre-existing pneumonia at the beginning of ventilation or
- Developing pneumonia within 48 hours of ventilation.
- Patients on oral antibiotics
Trial locations and contacts
1 site in 1 country.
India1 site
Maulana Azad Medical College and Lok Nayak Hospital
Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study
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.
Read the detailed description
Study population: Fifty patients of either sex admitted to Medical Intensive Care Unit and Intensive Care Unit of Anaesthesiology department of Maulana Azad Medical College and Lok Nayak Hospital, New Delhi( a 2000 bedded, tertiary care centre), fulfilling the criteria were enrolled and prospectively followed up until one week after discharge from intensive care unit or till death.
Methodology: Ventilator associated pneumonia was diagnosed when new and persistent pulmonary infiltrates (not otherwise explained) appeared on chest radiograph after 48 hours of ventilation and any two of the following three criteria were fulfilled:
- Temperature of more than 38oC or less than 35oC.
- Leukocytosis ≥16,000 or leukopenia ≤ 3,000.
- Purulent endotracheal aspirate and/or positive endotracheal aspirate culture. Protocol of study: All patients were ventilated by orotracheal or tracheostomy tube, which was changed only if, blocked or displaced. Patients were ventilated in supine position with frequent changing to right lateral and left lateral positions and nasogastric tube was put in all patients. No prophylactic topical oropharyngeal antibiotic and selective gut decontamination was done in any of the patients. Base line complete blood count was done in all patients at time of intubation. Subsequent counts were done when pneumonia was suspected by onset of fever, new chest signs, worsening of ventilatory requirement and radiologically new infiltrates. Baseline chest X-ray and endotracheal aspirate culture was done at intubation and at 48 hours of ventilation and subsequently done at suspicion of pneumonia or any other pulmonary complications, 48 hours after pneumonia has been detected, routinely once a week if no pneumonia is detected. Nasogastric aspirate culture was done on 3rd and 7th day of intubation and every week thereafter. Gastric colonization was diagnosed if more than 103 colony-forming units/ml were found. Clinical examination for pneumonia and chest radiographs after one week of extubation were done on follow up.
Method of collection of samples: Endotracheal aspirate was collected with mucus trap under all aseptic precautions. Nasogastric (NG) aspirate was collected from indwelling NG tubes. After removing the initial 5 ml, the next 10 ml of fluid in the tube was aspirated into a sterile syringe and immediately transported to the laboratory for processing.
Culture method: A Semi quantitative culture of the endotracheal aspirate and nasogastric aspirate was done [6]. A Measured amount of aspirate was plated on blood agar and Mac-Conkey medium and a colony count was done after incubation. A sample of blood was collected in glucose broth and after overnight incubation, subcultures were done on blood agar and Mac-Conkey agar. Colony characteristics were observed and identification was done in accordance with standard recommendations. Susceptibility of the organisms isolated from endotracheal aspirate was done by disc diffusion technique employing the Stokes method.
Grouping of patients: Patients enrolled into study were divided randomly into two groups on random basis. One group was given Ranitidine (H2 blocker) 50 mg I.V. every 8 hourly as stress ulcer prophylaxis while the other group recieved Sucralfate (surface active agent) 1g 6 hourly via nasogastric tube. Occurrence of VAP in each group was recorded and compared. Gastric colonization in each group was monitored by semi-quantitative culture.
Risk factors studied were age, sex, underlying disease, prior respiratory disease including Chronic obstructive airway disease (COPD), prior hospitalization, duration of intubation, numbers of intubations, prior antibiotic therapy etc. Other parameters noted were indication of mechanical ventilation and outcome of patients with VAP Statistical methods: Incidence, risk factors, outcome and antimicrobial susceptibility were calculated in absolute numbers and percentages. Comparison of effect of ranitidine vs. sucralfate on occurrence of VAP was done by chi square test and effect of ranitidine vs. sucralfate on gastric colonization was calculated in absolute numbers and percentages and compared. All statistics were calculated using SPSS software. P value <0.05 was considered significant.
RISK FACTORS studied include age, sex, underlying disease, prior COPD, prior hospitalization, duration of intubation, no. of intubation. Longer duration of dependence on ventilator increased the risk for VAP significantly (p value 0.001). Similarly, reintubation also emerged as clear predisposing factor for VAP (See table 1).
- Conditions
- Ventilator Associated Pneumonia, Etiological Organisms, Antimicrobial Drug Susceptibility Pattern, Stress Ulcer Prophylaxis
- Being tested
- Ranitidine, Sucralfate
- Keywords
- Ventilator Associated Pneumonia, antimicrobial susceptibility pattern, stress ulcer prophylaxis
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanitidineDrug
In arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay.
SucralfateDrug
In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis. Receives: Drug: Ranitidine |
| 2 | Active comparator | In arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay Receives: Drug: Sucralfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of ventilator associated pneumonia
Measured: till discharge from ICU or death of Patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startMar 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maulana Azad Medical College
- Sponsor type
- University, hospital or other
- Investigators
- Rajiv Singla, M.D., Principal investigator, Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702871
- Sponsor's protocol ID
- 403(7)/04MC(ACA)/Protocol/3499
- Status last verified
- Jun 2008
- First submitted
- 19 Jun 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00702871
- Acronym / sponsor ID
- 403(7)/04MC(ACA)/Protocol/3499
- Conditions
- Ventilator Associated Pneumonia, Etiological Organisms, Antimicrobial Drug Susceptibility Pattern, Stress Ulcer Prophylaxis
- Keywords
- Ventilator Associated Pneumonia, antimicrobial susceptibility pattern, stress ulcer prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maulana Azad Medical CollegeUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study population: Fifty patients of either sex admitted to Medical Intensive Care Unit and Intensive Care Unit of Anaesthesiology department of Maulana Azad Medical College and Lok Nayak Hospital, New Delhi( a 2000 bedded, tertiary care centre), fulfilling the criteria were enrolled and prospectively followed up until one week after discharge from intensive care unit or till death.
Methodology: Ventilator associated pneumonia was diagnosed when new and persistent pulmonary infiltrates (not otherwise explained) appeared on chest radiograph after 48 hours of ventilation and any two of the following three criteria were fulfilled:
- Temperature of more than 38oC or less than 35oC.
- Leukocytosis ≥16,000 or leukopenia ≤ 3,000.
- Purulent endotracheal aspirate and/or positive endotracheal aspirate culture. Protocol of study: All patients were ventilated by orotracheal or tracheostomy tube, which was changed only if, blocked or displaced. Patients were ventilated in supine position with frequent changing to right lateral and left lateral positions and nasogastric tube was put in all patients. No prophylactic topical oropharyngeal antibiotic and selective gut decontamination was done in any of the patients. Base line complete blood count was done in all patients at time of intubation. Subsequent counts were done when pneumonia was suspected by onset of fever, new chest signs, worsening of ventilatory requirement and radiologically new infiltrates. Baseline chest X-ray and endotracheal aspirate culture was done at intubation and at 48 hours of ventilation and subsequently done at suspicion of pneumonia or any other pulmonary complications, 48 hours after pneumonia has been detected, routinely once a week if no pneumonia is detected. Nasogastric aspirate culture was done on 3rd and 7th day of intubation and every week thereafter. Gastric colonization was diagnosed if more than 103 colony-forming units/ml were found. Clinical examination for pneumonia and chest radiographs after one week of extubation were done on follow up.
Method of collection of samples: Endotracheal aspirate was collected with mucus trap under all aseptic precautions. Nasogastric (NG) aspirate was collected from indwelling NG tubes. After removing the initial 5 ml, the next 10 ml of fluid in the tube was aspirated into a sterile syringe and immediately transported to the laboratory for processing.
Culture method: A Semi quantitative culture of the endotracheal aspirate and nasogastric aspirate was done [6]. A Measured amount of aspirate was plated on blood agar and Mac-Conkey medium and a colony count was done after incubation. A sample of blood was collected in glucose broth and after overnight incubation, subcultures were done on blood agar and Mac-Conkey agar. Colony characteristics were observed and identification was done in accordance with standard recommendations. Susceptibility of the organisms isolated from endotracheal aspirate was done by disc diffusion technique employing the Stokes method.
Grouping of patients: Patients enrolled into study were divided randomly into two groups on random basis. One group was given Ranitidine (H2 blocker) 50 mg I.V. every 8 hourly as stress ulcer prophylaxis while the other group recieved Sucralfate (surface active agent) 1g 6 hourly via nasogastric tube. Occurrence of VAP in each group was recorded and compared. Gastric colonization in each group was monitored by semi-quantitative culture.
Risk factors studied were age, sex, underlying disease, prior respiratory disease including Chronic obstructive airway disease (COPD), prior hospitalization, duration of intubation, numbers of intubations, prior antibiotic therapy etc. Other parameters noted were indication of mechanical ventilation and outcome of patients with VAP Statistical methods: Incidence, risk factors, outcome and antimicrobial susceptibility were calculated in absolute numbers and percentages. Comparison of effect of ranitidine vs. sucralfate on occurrence of VAP was done by chi square test and effect of ranitidine vs. sucralfate on gastric colonization was calculated in absolute numbers and percentages and compared. All statistics were calculated using SPSS software. P value <0.05 was considered significant.
RISK FACTORS studied include age, sex, underlying disease, prior COPD, prior hospitalization, duration of intubation, no. of intubation. Longer duration of dependence on ventilator increased the risk for VAP significantly (p value 0.001). Similarly, reintubation also emerged as clear predisposing factor for VAP (See table 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RanitidineArm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis. |
| 2 | Active comparator | Drug: SucralfateIn arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 12 years
- Those on mechanical ventilation for more than 48 hours.
Key exclusion criteria (3 listed)
- Pre-existing pneumonia at the beginning of ventilation or
- Developing pneumonia within 48 hours of ventilation.
- Patients on oral antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanitidineIn arm 1 Ranitidine was given in dose of 50mg i.v. 8 hourly for entire duration of ICU stay. | Drug | 1 |
| SucralfateIn arm 2, Sucralfate was given in dose of 1gm via nasogastric tube 6 hourly for entire duration of ICU stay | Drug | 2 |
Primary outcome
Occurence of ventilator associated pneumonia
Time frame: till discharge from ICU or death of Patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Singla, M.D. principal investigator
Maulana Azad Medical College and Lok Nayak Hospital, Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranitidine and Sucralfate in people with Ventilator Associated Pneumonia and Etiological Organisms, run by Maulana Azad Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of ventilator associated pneumonia (time frame: till discharge from ICU or death of Patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.