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Comparison of Pantoprazole and Ranitidine for preventing pulmonary infection in ICU

Comparison Ventilator Associated Pneumonia in two groups of adult ICU patients under prophylactic treatment by intravenous Pantoprazole or intravenous Ranitidine

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013072014079N1
Enrollment
166
Registered
2013-12-28
Start date
2013-06-17
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Pneumonia. Condition 2: GI bleeding. Bacterial pneumonia, not elsewhere classified K92.2 is a billable ICD-10-CM code that can be used to specify a diagnosis.

Interventions

Intervention 1: In the Experimental Group: Pantoprazole 40 mg ampoule is administrated intravenously every 12 hours until the patient is infected with pneumonia
the procedure continues for up to 48 hours following extubation. Manufacturing Company: Nycomed, Germany
Brand name: Pantazol. Intervention 2: In the Control Group: Ranitidine 50 mg is administrated intravenously every 8 hours until the patient is infected with pneumonia
the procedure continues for up to 48 hours following extubation. Manufacturing Company: Alborze darou.
Prevention
In the Experimental Group: Pantoprazole 40 mg ampoule is administrated intravenously every 12 hours until the patient is infected with pneumonia
Brand name: Pantazol.
In the Control Group: Ranitidine 50 mg is administrated intravenously every 8 hours until the patient is infected with pneumonia

Sponsors

Vice chancellor for research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. 18 Years of age and over 2. Intubation for more than 48 hours 3. No history of pneumonia within 3 months prior to or at the time of admission 4. No history of severe dysphagia 5. No history of deficiency in the immune system 6. No history of gastrointestinal bleeding 7. No history of gastrectomy, erosive gastritis, and reflux 8. No history of lung cancer 9. No transferring of patients from other ICUs. Exclusion Criteria: 1. Renal failure 2. Drug interference 3. Incidence of drug side effects 4. Gastrointestinal bleeding.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Ventilator Associated Pneumonia. Timepoint: Daily until the sputum is positively cultured or 48 hours after extubation. Method of measurement: Clinical Pulmonary Infection Score (CPIS)- Sputum Culture.

Secondary

MeasureTime frame
GI bleeding. Timepoint: Daily until the patient remains hospitalized. Method of measurement: Observing the coffee grain contents in the naso- or oro-gastric tube and Melena; checking vital signs such as blood pressure and heart rate, and hemoglobin.;Length of stay in ICU. Timepoint: At the end. Method of measurement: Observation.;Mortality in ICU. Timepoint: At the end. Method of measurement: Observation.;Mortality in ward. Timepoint: At the end. Method of measurement: Observation.;Duration of Mechanical Ventilation. Timepoint: Since the start of mechanical ventilation until the patient is disconnected from the machine. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHajar Faghihi

Shiraz University Medical Sciences

hajarfaghihi@gmail.com faghihih@sums.ac.ir+98 71 1228 9620

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026