Drug to Prevent Pneumonia in the Tube Fed

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02358642
• Other study ID #: ACEI-RCT
• Status: Terminated
• Phase: Phase 4
• First received: February 28, 2013
• Last updated: February 6, 2015
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deglutition Disorders
• Neurological Dysphagia
• Pneumonia

Intervention

Drug:
• Angiotensin converting enzyme inhibitor (Lisinopril)

• Placebo

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of pneumonia		week 26	No
Secondary	Number of pneumonia episodes		week 26	No