NCT03746002

Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing

Terminated Phase 4 Results posted Last updated 22 October 2021

What this trial tests

Phase 4 trial testing Metolazone 60 minutes prior to furosemide in Fluid Overload in 3 participants. Terminated before completion.

Timeline

1 January 2019

Primary endpoint
10 January 2020

10 January 2020

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 January 2019
Primary completion	10 January 2020
Estimated completion	10 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Metolazone 60 minutes prior to furosemide — full drug profile →
• Metolazone concurrently with furosemide — full drug profile →

Conditions studied

• Fluid Overload — all drugs for Fluid Overload →
• Heart Failure Acute — all drugs for Heart Failure Acute →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 89, any sex, with Fluid Overload or Heart Failure Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

24-Hour Urine Output Primary · 24 hours

Total measured urine output in milliliters produced after metolazone dose is given

Group	Value	95% CI
Metolazone Concurrent Dosing	2030	± 1626.3
Metolazone Pre-dosing	5650	± NA

Change in Total Body Weight Secondary · Baseline and at 12 to 23 hours after metolazone dose

Change in total body weight from baseline value measured prior to metolazone dose to value collected after metolazone dose

Group	Value	95% CI
Metolazone Concurrent Dosing	-.6	± 1.1
Metolazone Pre-dosing	-8.5	± NA

Change in Serum Creatinine Secondary · Baseline and at 12 to 23 hours after metolazone dose

Change in serum creatinine from baseline value collected prior to metolazone dose to value collected after metolazone dose

Group	Value	95% CI
Metolazone Concurrent Dosing	0.45	± 0.28
Metolazone Pre-dosing	0.38	± NA

Acute Kidney Injury Secondary · Baseline and at 12 to 23 hours after metolazone dose

Portion of patients with increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline

Group	Value	95% CI
Metolazone Concurrent Dosing	1
Metolazone Pre-dosing	1

Hypokalemia Secondary · Baseline and at 12 to 23 hours after metolazone dose

Proportion of patients with potassium level less than 4.0 mEq/L measured after metolazone dose is given

Group	Value	95% CI
Metolazone Concurrent Dosing	0
Metolazone Pre-dosing	1

Hypomagnesemia Secondary · Baseline and at 12 to 23 hours after metolazone dose

Proportion of patients with magnesium level less than 2.0 mg/dL measured after metolazone dose is given

Group	Value	95% CI
Metolazone Concurrent Dosing	0
Metolazone Pre-dosing	1

Hyponatremia Secondary · Baseline and at 12 to 23 hours after metolazone dose

Proportion of patients with serum sodium level less than 135 mg/dL measured after metolazone dose is given

Group	Value	95% CI
Metolazone Concurrent Dosing	0
Metolazone Pre-dosing	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours after metolazone dose (no greater than 48 hours after enrollment). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Metolazone Pre-dosing

Serious: 0/1 (0%)

Deaths: 0/1

Metolazone Concurrent Dosing

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (1 terms — click to expand)

Reaction	System	Metolazone Pre-dosing	Metolazone Concurrent Dosing
Acute kidney injury	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03746002 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.