Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment
NCT ID: NCT02188758
Last Updated: 2018-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2014-07-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults - CFPE Treatment
Other: CF Pulmonary Exacerbation (CFPE) Treatment
Adults - CFPE Treatment
Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.
Interventions
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Adults - CFPE Treatment
Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.
Eligibility Criteria
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Inclusion Criteria
* History of consistent sputum production on most occasions;
* FEV1% greater than or equal to 75% of best measurement in previous 6 months;
* 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;
* Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score \<5);
* Not admitted to hospital within the previous 3 weeks;
* Body weight greater than or equal to 75% of best measurement in previous 6 months;
* Provision of signed informed-consent to study protocol;
* 18\<Age\>65
* Recent and/or persistent visible blood in sputum (hemoptysis);
* Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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MaineHealth
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Alex H. Gifford
Associate Professor of Medicine
Locations
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Maine Medical Center
South Portland, Maine, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Gifford AH. What is hepcidin telling us about the natural history of cystic fibrosis? J Cyst Fibros. 2015 Jan;14(1):155-7. doi: 10.1016/j.jcf.2014.03.012. Epub 2014 Apr 30. No abstract available.
Gifford AH, Alexandru DM, Li Z, Dorman DB, Moulton LA, Price KE, Hampton TH, Sogin ML, Zuckerman JB, Parker HW, Stanton BA, O'Toole GA. Iron supplementation does not worsen respiratory health or alter the sputum microbiome in cystic fibrosis. J Cyst Fibros. 2014 May;13(3):311-8. doi: 10.1016/j.jcf.2013.11.004. Epub 2013 Dec 13.
Gifford AH. Hemoglobin </= 12.9 g/dl predicts risk of antibiotic treatment in cystic fibrosis. J Cyst Fibros. 2014 Jan;13(1):114-5. doi: 10.1016/j.jcf.2013.06.007. Epub 2013 Jul 16. No abstract available.
Gifford AH, Moulton LA, Dorman DB, Olbina G, Westerman M, Parker HW, Stanton BA, O'Toole GA. Iron homeostasis during cystic fibrosis pulmonary exacerbation. Clin Transl Sci. 2012 Aug;5(4):368-73. doi: 10.1111/j.1752-8062.2012.00417.x. Epub 2012 Jun 1.
Gifford AH, Miller SD, Jackson BP, Hampton TH, O'Toole GA, Stanton BA, Parker HW. Iron and CF-related anemia: expanding clinical and biochemical relationships. Pediatr Pulmonol. 2011 Feb;46(2):160-5. doi: 10.1002/ppul.21335. Epub 2010 Oct 20.
Other Identifiers
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D14136
Identifier Type: -
Identifier Source: org_study_id
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