Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Bayside Health
Updated on 7 November 2020

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.

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)

Details
Condition Cystic Fibrosis
Treatment Normal saline IV, salt tablets
Clinical Study IdentifierNCT00163852
SponsorBayside Health
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note