Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

September 12, 2005 updated by: Bayside Health

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3181
        • Recruiting
        • The Alfred
        • Contact:
        • Sub-Investigator:
          • Alan C Young, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Federation Australia

Investigators

  • Principal Investigator: Matthew T Naughton, MBBS, MD, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Normal saline IV, salt tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe