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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in India

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:

  1. Temperature of more than 38oC or less than 35oC.
  2. Leukocytosis ≥16,000 or leukopenia ≤ 3,000.
  3. 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).

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 groups in NCT00702871
Study groupRoleWhat they receive
1Active comparatorArm 1 was given Injection Ranitidine 50mg i.v. 8 hourly for stress ulcer prophylaxis.
Receives: Drug: Ranitidine
2Active comparatorIn 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.

  1. 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.

  1. First posted20 Jun 2008 (estimated)
  2. Study startMar 2005
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

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)
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

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.

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