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The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units

The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units of Poursina teaching remedial hospital of Rasht

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001174N13
Enrollment
92
Registered
2021-02-16
Start date
2021-04-10
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Ventilator-Associated Pneumonia. Other postprocedural respiratory disorders

Interventions

Intervention 1: Intervention group: The subjects in the probiotic group receive Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) along with routine nursing care to prevent VAP. Each cap

Sponsors

Deputy of Research and Technology of Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Written informed consent from the client's family or guardian Age 18 years and older Under mechanical ventilation for more than 48 hours Not more than 48 hours have passed since the intubated

Exclusion criteria

Exclusion criteria: Pregnancy at the time of admission Multiple organ dysfunction History of Pneumonia Having chronic pulmonary disease Having immunosuppression diseases Immunosuppressive drug usage Stomach, esophagus and intestines damage Airway injury

Design outcomes

Primary

MeasureTime frame
The incidence of Ventilator-Associated Pneumonia. Timepoint: All patients in both probiotic and placebo groups are monitored daily. Patients are monitored for Ventilator-Associated Pneumonia for up to 14 days after intubation and initiation of probiotic or placebo. Method of measurement: The American College of Chest Physicians and ICD-10 criteria will be used to diagnose Ventilator-Associated Pneumonia in intubated patients admitted to intensive care units. These criteria; "Existence of new and continuous infiltration in the chest image with 2 or 3 cases: increase in temperature above 38.5 ° C or decrease in temperature below 35 ° C, increase in white blood cells above 12,000 per microliter, or a decrease in white blood cells to less than 3,000 per microliter, and purulent sputum are considered to indicate Ventilator-Associated Pneumonia. For microbiological diagnosis of ventilator-associated pneumonia, " Endotracheal Aspirate" culture will be used in a "quantitative" manner. In this method, a number of colonies above 100,000 is considered as a microbiological diagnosis of ventilator-dependent pneumonia.

Secondary

MeasureTime frame
Duration of mechanical ventilation. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form.;Duration of hospitalization in the Intensive Care Unit. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form.;Mortality rate. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefeh Ghanbari

Guilan University of Medical Sciences

at_ghanbari@gums.ac.ir+98 13 3355 5056

Outcome results

None listed

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