Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00163852
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Federation Australia
Information provided by:
Bayside Health

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date September 14, 2005
Study Start Date  ICMJE February 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Official Title  ICMJE Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
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.

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: Normal saline IV, salt tablets
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 12, 2005)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163852
Other Study ID Numbers  ICMJE 14/04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bayside Health
Collaborators  ICMJE
  • National Health and Medical Research Council, Australia
  • Monash University
  • Cystic Fibrosis Federation Australia
Investigators  ICMJE
Principal Investigator: Matthew T Naughton, MBBS, MD The Alfred
PRS Account Bayside Health
Verification Date September 2005

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