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
672 participants
OBSERVATIONAL
2021-01-01
2021-09-30
Brief Summary
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MA is a common complication of heart failure (HF) especially when patients are treated with diuretics, but few studies have analyzed the prevalence of acid-base disorders in patients with HF.
All these studies have shown that MA is more common in patients with HF in more advanced stages and that the use of diuretics increases the prevalence of MA.
The study hypothesis, based on clinical experience and the few data that exist in the scientific literature, is that MA is a frequent analytical disorder in patients admitted for decompensated HF and that its presence entails a worse short-term vital prognosis.
The ALCALOTIC study is an observational cohort and prospective study.
The main objectives of the study are the following:
1. To determine the prevalence of MA in patients admitted for decompensated HF
2. To analyze if there are differences in patients admitted for HF according to the presence of MA on admission
3. To determine if the presence of MA has an influence on the short-term prognosis in patients admitted for decompensated HF
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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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Cohort of exposed patients (Group 1)
All patients admitted for decompensated HF and presenting MA at the time of admission
No interventions assigned to this group
Cohort of unexposed patients (Group 2)
All patients admitted for decompensated HF and who do NOT present MA at the time of admission
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients must give their written consent to participate in the study
Exclusion Criteria
* Patients who do not strictly meet the diagnostic criteria for HF of the European HF Guidelines.
* Patients for whom analytical values are not available in relation to acid-base balance at the time of admission
* Patients with a pathological history that can clearly justify metabolic alkalosis, such as primary or secondary hyperaldosterism
* Patients who were taking sodium bicarbonate prior to admission
* Patients with factors present at admission that may justify the presence of metabolis alkalosis: vomiting, diarrea, etc.
* Patients who do not give their consent to participate in the study
18 Years
ALL
No
Sponsors
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Spanish Society of Internal Medicine
OTHER
Responsible Party
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Joan Carles Trullas Vila
Principal Investigator. Heart Failure Workin Group. Spanish Society of Internal Medicine
Locations
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Internal Medicine Service, Hospital d'Olot (Girona)
Olot, Girona, Spain
Countries
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References
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Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.
Peixoto AJ, Alpern RJ. Treatment of severe metabolic alkalosis in a patient with congestive heart failure. Am J Kidney Dis. 2013 May;61(5):822-7. doi: 10.1053/j.ajkd.2012.10.028. Epub 2013 Mar 5.
Other Identifiers
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ALCALOTIC
Identifier Type: -
Identifier Source: org_study_id
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