Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00163852|
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
|First Submitted Date ICMJE||September 12, 2005|
|First Posted Date ICMJE||September 14, 2005|
|Last Update Posted Date||September 14, 2005|
|Study Start Date ICMJE||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis|
|Official Title ICMJE||Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis|
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.
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.
Random allocation to either:
Primary outcome measures: (D1, D4, D10)
Secondary outcome measures: (D1, D4, D10)
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Cystic Fibrosis|
|Intervention ICMJE||Drug: Normal saline IV, salt tablets|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Concurrent diuretic therapy Concurrent glucocorticoid therapy
|Ages ICMJE||18 Years to 75 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Australia|
|Removed Location Countries|
|NCT Number ICMJE||NCT00163852|
|Other Study ID Numbers ICMJE||14/04|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Bayside Health|
|PRS Account||Bayside Health|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP