Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome measures: (Day1, D4, D10)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Concurrent diuretic therapy Concurrent glucocorticoid therapy
结局指标
主要结局
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)
次要结局
- •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)
- Secondary outcome measures: (Day1, D4, D10)
- •Serum albumin, sodium
- •Body mass index (BMI)
- •Spirometry (D1, D10)
- •Headache scale
- •Epworth sleepiness scale