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
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Normal saline IV, salt tablets
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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:
  • 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)

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: February 2006
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:

  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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163852

Contacts
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

Locations
Australia, Victoria
The Alfred Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Alan C Young, MBBS    613 9276 2000 ext pager 4576    alan.young@med.monash.edu.au   
Sub-Investigator: Alan C Young, MBBS         
Sponsors and Collaborators
Bayside Health
National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Australia
Investigators
Principal Investigator: Matthew T Naughton, MBBS, MD The Alfred
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163852     History of Changes
Other Study ID Numbers: 14/04
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Bayside Health:
Cystic fibrosis
Metabolic alkalosis
Hypercapnia
Salt replacement

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Alkalosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Acid-Base Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014