Clinical trial NCT02358642: Drug to Prevent Pneumonia in the Tube Fed
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pneumonia
Neurological Dysphagia
Keywords: Rate of Pneumonia
Mortality rate
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 93
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Incidence rate of pneumonia
timeFrame: week 26
Secondary outcomes:
measure: Number of pneumonia episodes
timeFrame: week 26
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: