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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704923
Other study ID # CAAE 40374815.3.0000.5342
Secondary ID
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


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
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