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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163852




Registration number
NCT00163852
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005

Titles & IDs
Public title
Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Scientific title
Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Secondary ID [1] 0 0
14/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary outcome measures: (Day1, D4, D10)
Timepoint [1] 0 0
Primary outcome [2] 0 0
•PaCO2 (performed at same time of day as admission ABG's)
Timepoint [2] 0 0
Primary outcome [3] 0 0
•Acid-base status (Stinebaugh and Austin, ABG's)
Timepoint [3] 0 0
Primary outcome [4] 0 0
•Serum chloride
Timepoint [4] 0 0
Primary outcome [5] 0 0
•Overnight oximetry (% night SpO2<90%) and PtcCO2 (rise in CO2 overnight)
Timepoint [5] 0 0
Secondary outcome [1] 0 0
Secondary outcome measures: (Day1, D4, D10)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
•Serum albumin, sodium
Timepoint [2] 0 0
Secondary outcome [3] 0 0
•Body mass index (BMI)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
•Spirometry (D1, D10)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
•Headache scale
Timepoint [5] 0 0
Secondary outcome [6] 0 0
•Epworth sleepiness scale
Timepoint [6] 0 0
Secondary outcome [7] 0 0
•Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10)
Timepoint [7] 0 0
Secondary outcome [8] 0 0
•Urinary chloride, potassium, sodium, pH, osmolality
Timepoint [8] 0 0
Secondary outcome [9] 0 0
•Baseline ABG's as stable outpatient (within 3 months, pre or post admission)
Timepoint [9] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Concurrent diuretic therapy Concurrent glucocorticoid therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cystic Fibrosis Federation Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00163852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew T Naughton, MBBS, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alan C Young, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
613 9276 2000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163852