Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Australia
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163852
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
February 2004
Not Provided
  • 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)
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
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.

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:

  1. Intervention + standard care (including standard dietary advice) D1-10
  2. 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)
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
Drug: Normal saline IV, salt tablets
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
February 2006
Not Provided

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

Both
18 Years to 75 Years
Yes
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
 
NCT00163852
14/04
Not Provided
Not Provided
Bayside Health
  • National Health and Medical Research Council, Australia
  • Monash University
  • Cystic Fibrosis Australia
Principal Investigator: Matthew T Naughton, MBBS, MD The Alfred
Bayside Health
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP