Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing

University of Maryland Baltimore (UMB)

Status and phase: Terminated; Phase 4

Conditions: Fluid Overload; Heart Failure Acute

Treatments: Drug: Metolazone concurrently with furosemide; Drug: Metolazone 60 minutes prior to furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT03746002

HP-00082982

Details and patient eligibility

About

The purpose of this study is to examine whether administering metolazone 60 minutes prior to furosemide increases urine output compared with administering metolazone and furosemide concomitantly. Participants will have equal chance of being assigned to each group.

Full description

Diuretic resistance is common among patients with acute decompensated heart failure, and one strategy for overcoming this phenomenon is sequential nephron blockade with loop plus thiazide-type diuretics. Metolazone is an oral thiazide-type diuretic commonly used for this purpose. Due to its delayed absorption, some clinicians suggest that metolazone be given 30-60 minutes prior to the loop diuretic. However, the efficacy and safety of such a strategy has not been investigated despite its added complexity. The purpose of this study is to investigate whether pre-dosing with metolazone confers a difference in efficacy and safety compared to administering it at the same time as furosemide.

Enrollment: 3 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission within 48 hours for acute decompensated heart failure with at least one symptom and one sign of volume overload
• Receipt of loop diuretic prior to admission
• Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours with additional diuresis deemed necessary
• If patient is concurrently administered intravenous vasodilator or inotrope, the dose of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan to continue the same dose for the 24 hour duration of this study

Exclusion criteria

• Metolazone prescribed prior to admission
• Receipt of continuous intravenous infusion of furosemide
• Cirrhosis or end stage renal disease
• Non-English speaking patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Metolazone Pre-dosing

Active Comparator group

Description:

Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)

Treatment:

Drug: Metolazone 60 minutes prior to furosemide

Metolazone Concurrent Dosing

Active Comparator group

Description:

Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)

Treatment:

Drug: Metolazone concurrently with furosemide