NCT00163852

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisMetabolic alkalosisHypercapniaSalt replacement

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (9)

  • Secondary outcome measures: (Day1, D4, D10)

  • •Serum albumin, sodium

  • •Body mass index (BMI)

  • •Spirometry (D1, D10)

  • •Headache scale

  • +4 more secondary outcomes

Interventions

Normal saline IV, salt tabletsDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Concurrent diuretic therapy Concurrent glucocorticoid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred

Melbourne, Victoria, 3181, Australia

RECRUITING

MeSH Terms

Conditions

Cystic FibrosisHypercapnia

Interventions

Salts

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Matthew T Naughton, MBBS, MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan C Young, MBBS, FRACP

CONTACT

613 9276 2000alan.young@med.monash.edu.au

Matthew T Naughton, MBBS, FRACP

CONTACT

613 9276 2000m.naughton@alfred.org.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

February 1, 2004

Study Completion

February 1, 2006

Last Updated

September 14, 2005

Record last verified: 2005-09

Locations

AU(1)