Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163852
Status:
UNKNOWN
Last Update Posted:
2005-09-14
First Post:
2005-09-12
Brief Title:
Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mmolL
Serum albumin alb 25 mmolL
Intervention
Normal saline intravenously dayD123 Replace greater of Cl deficiency or acute weight loss with 23 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 ABGs
Acid-base status Stinebaugh and Austin ABGs
Serum chloride
Overnight oximetry night SpO290 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 levelD1-10
Urinary chloride potassium sodium pH osmolality
Baseline ABGs as stable outpatient within 3 months pre or post admission
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 mmolL
Serum albumin alb 25 mmolL
Intervention
Normal saline intravenously dayD123 Replace greater of Cl deficiency or acute weight loss with 23 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 ABGs
Acid-base status Stinebaugh and Austin ABGs
Serum chloride
Overnight oximetry night SpO290 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 levelD1-10
Urinary chloride potassium sodium pH osmolality
Baseline ABGs as stable outpatient within 3 months pre or post admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None