Cystic FibrosisPhase 2/3NCT00163852
Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
A Phase 2/3 study testing Normal saline IV, salt tablets in people with Cystic Fibrosis, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Normal saline IV, salt tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2004to Feb 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concurrent diuretic therapy Concurrent glucocorticoid therapy
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Alfred
Melbourne, Victoria, 3181
Alan C Young, MBBS, 613 9276 2000 ext. pager 4576, alan.young@med.monash.edu.au
Alan C Young, MBBS
About this study
Official title: 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.
Read the 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)
- Conditions
- Cystic Fibrosis
- Being tested
- Normal saline IV, salt tablets
- Keywords
- Cystic fibrosis, Metabolic alkalosis, Hypercapnia, Salt replacement
- Medical subject headings
- Cystic Fibrosis, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline IV, salt tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (9)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia, Monash University, Cystic Fibrosis Federation Australia
- Investigators
- Matthew T Naughton, MBBS, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163852
- Sponsor's protocol ID
- 14/04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00163852
- Acronym / sponsor ID
- 14/04
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Metabolic alkalosis, Hypercapnia, Salt replacement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- National Health and Medical Research Council, Australia, Monash University, Cystic Fibrosis Federation Australia
- Study start
- Feb 2004
- Study completion
- Feb 2006
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Concurrent diuretic therapy Concurrent glucocorticoid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline IV, salt tablets | Drug | – |
Primary outcome
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)
9 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew T Naughton, MBBS, MD principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Normal saline IV, salt tablets in people with Cystic Fibrosis, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan C Young, MBBS, FRACP (613 9276 2000 ext. pager 4576, alan.young@med.monash.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures: (Day1, D4, D10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2005.