Edema Clinical Trial
Official title:
Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload
This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | March 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male or female patients with ages = 18 years old, and less than 65 years old. - For both elective and emergency hospital admissions, patients with a clinical diagnosis of ADHF must exhibit at least one clinical sign indicative of volume overload. These signs may include edema (score 2 or higher), ascites confirmed through echography, or pleural effusion confirmed by chest X-ray or echography or rales on auscultation, or jugular venous pressure greater than10 mm Hg. Exclusion Criteria: - Patient diagnosed with acute kidney injury upon hospital admission based on the presence of any of the following criteria: an increase in SCr by at least 0.3 mg/dL within 48 hours, an increase in SCr to at least 2 times the baseline value, known or presumed to have occurred within the prior 7 days, and a urine volume less than 0.5 ml/kg/hour for a duration of 6 hours. - Patients with acute pulmonary edema caused by increased afterload and fluid redistribution to the lungs in the absence or with minimal fluid accumulation. - Anticipated exposure to nephrotoxic agents (such as contrast dye) during hospitalization. - Patients who exhibit anuria or are undergoing renal replacement therapy or ultrafiltration. - Patients with eGFR less than 30 mL/min/1.73m² at the time of screening. - Expected use of intravenous inotropes, vasopressors, or nitroprusside during the study. - Prior cardiac transplantation and/or utilization of a ventricular assist device. - Blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg at the time of recruitment. - Patients who are pregnant or breastfeeding. - Administration of acetazolamide or metolazone within the one-month period preceding randomization. - The usage of any diuretic agent during the treatment phase is not specified in the study protocol, except for mineralocorticoid receptor antagonists. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Heart Institute | Giza | GZ |
Lead Sponsor | Collaborator |
---|---|
Cairo University | National Heart Institute, Egypt |
Egypt,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine Output | Total Urine output Volume | 48 Hours | |
Secondary | Diuretic Response | Urine output/40 mg furosemide equivalent | 48 Hours | |
Secondary | Body Weight | Change in Body Weight | 48 Hours | |
Secondary | Congestion Score | Change in congestion score (Modified ADVOR Trial Congestion Score) | 48 Hours | |
Secondary | NT-proBNP/BNP | Change in NT-Pro BNP/BNP levels | On admission and before discharge (up to 2 Weeks) | |
Secondary | Bicarbonate Level | Change in bicarbonate level from baseline [ABG] | 48 Hours | |
Secondary | Serum Creatinine | Change in serum creatinine (SCr) | 48 Hours | |
Secondary | eGFR | Change in estimated glomerular filtration rate (eGFR) from baseline | 48 Hours | |
Secondary | Blood Pressure | Change in systolic blood pressure (SBP) from baseline | 48 Hours | |
Secondary | Serum Potassium | Change in serum potassium from baseline | 48 Hours | |
Secondary | Length of Hospital Stay | Both general ward and CCU | Up to 2 weeks | |
Secondary | Mortality or HF Events | All-cause mortality and heart failure readmission during 3 months of follow-up | 3 Months |
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