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| Sponsors and Collaborators: |
Bayside Health National Health and Medical Research Council, Australia Monash University Cystic Fibrosis Australia |
|---|---|
| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00163852 |
Purpose
Adult cystic fibrosis (CF) patients admitted with an acute infection complicated by acid-base disturbance and decreased ventilation will be studied.
They will receive salt replacement to correct the acid-base disturbance and possibly their ventilation.
Assessment of symptoms (questionnaire), acid-base and electrolyte status (blood and urine tests) ventilation (overnight oxygen and carbon dioxide monitoring non-invasively) and sleep-wake pattern (actigraphy) will be carried out.
Study hypothesis: Acute volume and electrolyte replacement corrects hypochloremic hypovolemic metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of cystic fibrosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Normal saline IV, salt tablets |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | February 2006 |
Background: Hypochloremic hypovolemic metabolic alkalosis contributes to hypercapnia in acute exacerbations of cystic fibrosis. Treatment of the metabolic alkalosis with volume and sodium chloride (NaCl) replacement could reduce hypoventilation and hypercapnia, thereby improving symptoms, sleep patterns and daytime activity level. This would avoid unnecessary treatment with non-invasive ventilation.
Hypothesis: Volume and NaCl replacement corrects hypochloremic hypovolemic metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of cystic fibrosis and results in symptomatic improvement.
Entry criteria:
Intervention:
Random allocation to either:
Primary outcome measures: (D1, D4, D10)
Secondary outcome measures: (D1, D4, D10)
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Concurrent diuretic therapy Concurrent glucocorticoid therapy
Contacts and Locations| Contact: Alan C Young, MBBS, FRACP | 613 9276 2000 ext pager 4576 | alan.young@med.monash.edu.au |
| Contact: Matthew T Naughton, MBBS, FRACP | 613 9276 2000 ext 3770 | m.naughton@alfred.org.au |
| Australia, Victoria | |
| The Alfred | Recruiting |
| Melbourne, Victoria, Australia, 3181 | |
| Contact: Alan C Young, MBBS 613 9276 2000 ext pager 4576 alan.young@med.monash.edu.au | |
| Sub-Investigator: Alan C Young, MBBS | |
| Principal Investigator: | Matthew T Naughton, MBBS, MD | The Alfred |
More Information
| Study ID Numbers: | 14/04 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00163852 History of Changes |
| Health Authority: | Australia: Therapeutic Goods Administration |
|
Cystic fibrosis Metabolic alkalosis Hypercapnia Salt replacement |
|
Digestive System Diseases Metabolic Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Hypercapnia Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Metabolic Disorder Alkalosis |
|
Pathologic Processes Digestive System Diseases Metabolic Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Alkalosis Acid-Base Imbalance |