Drug to Prevent Pneumonia in the Tube Fed

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

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.

Study Overview

• Status: Terminated
• Conditions: Pneumonia; Neurological Dysphagia
• Intervention / Treatment: Drug: Placebo; Drug: Angiotensin converting enzyme inhibitor (Lisinopril)

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Angiotensin converting enzyme inhibitor; Angiotensin converting enzyme inhibitor (Lisinopril), 2.5mg, nocte, 26 weeks	Drug: Angiotensin converting enzyme inhibitor (Lisinopril)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of pneumonia	week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of pneumonia episodes	week 26

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Mortality rate; Rate of Pneumonia
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Pneumonia; Deglutition Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Lisinopril; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: ACEI-RCT