Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis
Paraules clau
Resum
Descripció
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)
Dates
| Darrera verificació: | 08/31/2005 |
| Primer enviat: | 09/11/2005 |
| Inscripció estimada enviada: | 09/11/2005 |
| Publicat per primera vegada: | 09/13/2005 |
| Última actualització enviada: | 09/11/2005 |
| Publicació de l'última actualització: | 09/13/2005 |
| Data d'inici de l'estudi real: | 01/31/2004 |
| Data estimada de finalització de l’estudi: | 01/31/2006 |
Condició o malaltia
Intervenció / tractament
Drug: Normal saline IV, salt tablets
Fase
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Primary outcome measures: (Day1, D4, D10) [undefined]
2. •PaCO2 (performed at same time of day as admission ABG's) [undefined]
3. •Acid-base status (Stinebaugh and Austin, ABG's) [undefined]
4. •Serum chloride [undefined]
5. •Overnight oximetry (% night SpO2<90%) and PtcCO2 (rise in CO2 overnight) [undefined]
Mesures de resultats secundaris
1. Secondary outcome measures: (Day1, D4, D10) [undefined]
2. •Serum albumin, sodium [undefined]
3. •Body mass index (BMI) [undefined]
4. •Spirometry (D1, D10) [undefined]
5. •Headache scale [undefined]
6. •Epworth sleepiness scale [undefined]
7. •Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10) [undefined]
8. •Urinary chloride, potassium, sodium, pH, osmolality [undefined]
9. •Baseline ABG's as stable outpatient (within 3 months, pre or post admission) [undefined]
