Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acetazolamide
DrugAcetazolamide is a medication that belongs to the class of carbonic anhydrase inhibitors. It acts by reducing the reabsorption of sodium in the proximal tubules of the kidneys. When combined with loop diuretics, acetazolamide has the potential to enhance the effectiveness of diuretic therapy, thus aiding in the process of decongestion. It will be given 500mg orally, once daily.
Metolazone
DrugMetolazone is a medication with properties like thiazide diuretics, prescribed for the management of congestive heart failure and hypertension. Its mechanism of action involves blocking the transport of sodium across the epithelium of renal tubules, predominantly in the distal tubules. It will be given 5mg orally, once daily.
IV Loop Diuretics
DrugIV loop diuretic 2 times the outpatient oral (PO) daily dose, and oral loop diuretics will be stopped. In cases where the patient was not previously on oral diuretics, a starting dose of 40 mg of IV furosemide, IV bumetanide 1 mg or a bolus of 20 mg of IV torsemide can be utilized.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Urine Output
Total Urine output Volume
Time frame
48 HoursSecondary outcomes
1
Diuretic Response
Urine output/40 mg furosemide equivalent
Time frame
48 Hours2
Body Weight
Change in Body Weight
Time frame
48 Hours3
Congestion Score
Change in congestion score (Modified ADVOR Trial Congestion Score)
Time frame
48 Hours4
NT-proBNP/BNP
Change in NT-Pro BNP/BNP levels
Time frame
On admission and before discharge (After 48 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cairo University
Lead sponsor
Misr International University
Sponsor institution
National Heart Institute, Egypt
Collaborator
Source ClinicalTrials.gov