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Drug to Prevent Pneumonia in the Tube Fed

NCT02358642 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2015-02-09

No results posted yet for this study

Summary

Background: Older people with neurological dysphagia are at risk of recurrent aspiration pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia.

Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed because of dysphagia from cerebrovascular diseases.

Design: Randomized placebo controlled trial

Method: 302 older patients who have been tube fed for more than two weeks because of dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5 mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech therapy clinics, who have had hospital stay in previous three months. The subjects are followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public health care and personal health care costs will be performed. Intention to treat and log rank will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing videofluoscopy at baseline and week 12 follow-up.

Conditions

Interventions

DRUG

Angiotensin converting enzyme inhibitor (Lisinopril)

DRUG

Placebo

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358642 on ClinicalTrials.gov