- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163852
Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Adult cystic fibrosis patient
- Admission with acute exacerbation
- PaCO2 > 45 mmHg
- Primary metabolic alkalosis (acid-base diagram of Stinebaugh and Austin)
- Serum chloride (Cl) ≤ 98 mmol/L
- Serum albumin (alb) > 25 mmol/L
Intervention:
- Normal saline intravenously day(D)1,2,3. (Replace greater of Cl deficiency or acute weight loss, with 2/3 on D1 and remainder D2, D3)
- NaCl tablets 3 tds D4 to 10 (calculated to replace 7 mmol NaCl loss in 60 kg subject)
Random allocation to either:
- Intervention + standard care (including standard dietary advice) D1-10
- Standard care alone (including standard dietary advice) D1-10
Primary outcome measures: (D1, D4, D10)
- PaCO2 (performed at same time of day as admission ABG's)
- Acid-base status (Stinebaugh and Austin, ABG's)
- Serum chloride
- Overnight oximetry (% night SpO2<90%) and PtcCO2 (rise in CO2 overnight)
Secondary outcome measures: (D1, D4, D10)
- Serum albumin, sodium
- Body mass index (BMI)
- Spirometry (D1, D10)
- Headache scale
- Epworth sleepiness scale
- Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10)
- Urinary chloride, potassium, sodium, pH, osmolality
- Baseline ABG's as stable outpatient (within 3 months, pre or post admission)
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Alan C Young, MBBS, FRACP
- Phone Number: pager 4576 613 9276 2000
- Email: alan.young@med.monash.edu.au
Study Contact Backup
- Name: Matthew T Naughton, MBBS, FRACP
- Phone Number: 3770 613 9276 2000
- Email: m.naughton@alfred.org.au
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3181
- Recruiting
- The Alfred
-
Contact:
- Alan C Young, MBBS
- Phone Number: pager 4576 613 9276 2000
- Email: alan.young@med.monash.edu.au
-
Sub-Investigator:
- Alan C Young, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult cystic fibrosis patient
- Admission with acute exacerbation (criteria- fall in FEV1 > 10% from best in last 12/12, change in sputum volume and colour, new pulmonary infiltrate)
- PaCO2 > 45 mmHg on admission
- Primary metabolic alkalosis (acid-base diagram of Stinebaugh and Austin)
- Serum chloride (Cl) ≤ 98 mmol/L
- Serum albumin (alb) ≤ 25 mmol/L
Exclusion Criteria:
Concurrent diuretic therapy Concurrent glucocorticoid therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Primary outcome measures: (Day1, D4, D10)
|
•PaCO2 (performed at same time of day as admission ABG's)
|
•Acid-base status (Stinebaugh and Austin, ABG's)
|
•Serum chloride
|
•Overnight oximetry (% night SpO2<90%) and PtcCO2 (rise in CO2 overnight)
|
Secondary Outcome Measures
Outcome Measure |
---|
Secondary outcome measures: (Day1, D4, D10)
|
•Serum albumin, sodium
|
•Body mass index (BMI)
|
•Spirometry (D1, D10)
|
•Headache scale
|
•Epworth sleepiness scale
|
•Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10)
|
•Urinary chloride, potassium, sodium, pH, osmolality
|
•Baseline ABG's as stable outpatient (within 3 months, pre or post admission)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew T Naughton, MBBS, MD, The Alfred
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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