Drug to Prevent Pneumonia in the Tube Fed
Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia; Neurological Dysphagia
Intervention: Angiotensin converting enzyme inhibitor (Lisinopril) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Chinese University of Hong Kong
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.
Clinical Details
Official title: A Randomized Placebo Controlled Trial of Low Dose Angiotensin Converting Enzyme Inhibitor to Prevent Pneumonia in Older People Who Require Tube Feeding Because of Neurological Dysphagia
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Incidence rate of pneumonia
Secondary outcome: Number of pneumonia episodes
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Tube fed for more than four weeks for reason of neurological dysphagia as recommended
by a trained speech therapist;
- clinical diagnosis of cerebrovascular diseases, confirmed by CT head scan. The reason
for restricting the subjects to those with cerebrovascular disease is that previous
studies which showed beneficial effects of ACEI on dysphagia were mostly based on
stroke patients.
Exclusion Criteria:
- life expectancy less than six months;
- live outside Shatin area;
- systolic blood pressure less than 100 mm Hg;
- known intolerance of ACEI;
- existing use of ACEI or angiotensin receptor blockers;
- symptomatic chronic lung disease or cardiac failure;
- frequent withdrawal of enteral tube by patients;
- serum creatinine >100 µmol/L;
- serum potassium > 5. 1 mmol/L.
Locations and Contacts
Prince of Wales Hospital, Hong Kong, Hong Kong
Additional Information
Starting date: September 2010
Last updated: February 6, 2015
|
