Clinical trial NCT04740242: Metabolic Alkalosis in Heart Failure
Official title: ALCALOTIC Study: Metabolic Alcalosis in Decompensated Heart Failure: Prevalence and Influence on Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Metabolic Alkalosis
Diuretics Drug Reactions
Decompensated Heart Failure
Acute Heart Failure
Keywords: metabolic alkasosis
heart failure
Lead sponsor: Spanish Society of Internal Medicine
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be recruited from the Internal Medicine Services of Spanish Hospitals whose researchers are active members of the Working Group on Heart Failure and Atrial Fibrillation of the Spanish Society of Internal Medicine

Brief summary: Metabolic alkalosis (MA) is the most common acid-base disorder and when it's severe it can have effects on cellular function and contribute to an increase in mortality.

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


Eligibility criteria: Inclusion Criteria:

* Patient admitted for decompensated HF (main admission diagnosis), who meet the diagnostic criteria of the 2016 European HF Guidelines and who sign the informed consent to participate in the study
* Patients must give their written consent to participate in the study

Exclusion Criteria:

* Patients whose main reason for admission is not decompensated HF. Those patients who are admitted for another reason and who also have decompensated HF secondarily cannot be included
* 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: an average of 7 days
Secondary outcomes:
measure: Mortality during follow-up
timeFrame: Mortality at 30 and 90 days after hospital discharge
measure: Re-admission (all cause) during follow-up
timeFrame: Re-admission at 30 and 90 days after hospital discharge
measure: Readmission for heart failure during follow-up
timeFrame: Readmission for heart failure 30 and 90 days after hospital discharge
measure: Lenght of Hospital stay
timeFrame: Lenght of Hospital stay will be determined the day of hospital discharge, an average of 7 days after admission/inclusion
Other outcomes:
Locations:
city: Olot
country: Spain
facility: Internal Medicine Service, Hospital d'Olot (Girona)
state: Girona
Study officials:
References:
citation: Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.
citation: 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.