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Introduction: Recent studies have suggested that the use of acetazolamide may assist in the vol- ume management of patients with decompensated heart failure (HF). However, prospective and randomized comparison in patients with HF and optimized diuretic therapy has not been described. Objective: The aim of this study was to evaluate the effectiveness and safety of the use of acetazolamide versus placebo in volume control in patients with decompensated HF. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of acetazolamide as an adjuvant treatment is superior to the standard strategy for volume control in patients with decompensated HF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Experimental | All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the acetazolamide group, he / she will start using the adjuvant medication as acetazolamide drug capsule at the daily dose of 250 mg / day (oral) during the first three days of treatment. |
|
| Placebo | Experimental | All patients will receive an initial dose of intravenous furosemide of 1mg / kg, subsequently descaled to 0.5mg / kg of 6 / 6h, associated with oral hydrochlorothiazide 25mg / day and spironolactone 25mg / day orally. When the patient is randomized to the placebo group, he / she will start using the placebo drug capsule during the first three days of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| diuresis and negative water balance | The comparison between groups for diuresis and negative water balance | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cases with worsening of renal function | worsening of renal function (increase of 0.5 mg / dl or 25% increase in relation to admission creatinine) | 72 hours |
| Number of cases with lowering of consciousness level |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
COPD
Hepatical cirrhosis
Known allergy to acetazolamide
2nd or 3rd degree atrioventricular block.
SBP <90 mmHg or need for vasopressor / inotropic use.
Body mass index greater than 40 kg / m2.
Acute coronary syndrome.
Orotracheal intubation.
Presence of significant pericardial effusion.
Left ventricular outflow tract obstruction.
Serum creatinine> 5.0 mg / dL, creatinine clearance <10 mL / min or hemodialysis.
Presence of 2 or more clinical / laboratory / radiological criteria of infection defined by:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Soeiro, MD | Contact | +551126615299 | alexandre.soeiro@bol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Mucio Tavares, MD | Unidade ClÃnica de Emergência | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração - HMFMUSP | Recruiting | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication. |
|
lowering of consciousness level
| 72 hours |
| Number of cases with circulatory assistance | need for mechanical circulatory assistance | 72 hours |
| Number of cases with vasopressor | need for vasopressor or inotropic association | 72 hours |
| Number of cases with orotracheal intubation | need for orotracheal intubation | 72 hours |
| Number of cases with arrhythmia | occurrence of sustained ventricular arrhythmia | 72 hours |
| Number of cases with acetazolamide side effects | need for suspension of acetazolamide due to side effects | 72 hours |
| Number of cases of death | ocurrence of death | 72 hours |
| Level of Base excess | Comparison of all hemodynamic / metabolic parameters to be evaluated (base excess) | 30 days |
| Level of bicarbonate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Rate of systolic and diastolic blood pressure | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of cardiac output | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of systolic volume | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of arterial lactate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of BNP | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of troponin | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| heart rate | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of sodium | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of potassium | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of creatinine | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| Level of urea | Comparison of all hemodynamic / metabolic parameters to be evaluated | 30 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |