Atropine for Preventing Ventilator-Associated Pneumonia

Ventilator-Associated Pneumonia Clinical Trial

Official title:

Atropine for Preventing Ventilator-Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704923
• Other study ID #: CAAE 40374815.3.0000.5342
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2016
• Last updated: March 9, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Comissão Nacional de Ética em Pesquisa (CONEP)
• Study type: Interventional

Clinical Trial Summary

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

Description:

A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours

Exclusion Criteria:

• Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

Drug:
• Atropine
Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
• Placebo
Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade de Passo Fundo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Incidence of adverse events through the end of the study, an average of one year	through the end of the study, an average of one year	Yes
Primary	Ventilator-Associated Pneumonia	Incidence of ventilator-associated pneumonia through the end of the study, an average of one year	through the end of the study, an average of one year	No
Secondary	Death	Incidence of death through the end of the study, an average of one year	through the end of the study, an average of one year	No