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Trial record 66 of 242 for:    furosemide

Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing

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ClinicalTrials.gov Identifier: NCT03746002
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Brent Reed, University of Maryland, Baltimore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fluid Overload Heart Failure Acute Drug: Metolazone 60 minutes prior to furosemide Drug: Metolazone concurrently with furosemide Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label, active control pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing With Furosemide: a Pilot Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metolazone Pre-dosing
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)
Drug: Metolazone 60 minutes prior to furosemide
All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
Other Name: Zaroxolyn

Active Comparator: Metolazone Concurrent Dosing
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)
Drug: Metolazone concurrently with furosemide
All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
Other Name: Zaroxolyn




Primary Outcome Measures :
  1. 24-Hour Urine Output [ Time Frame: 24 hours ]
    Total measured urine output in milliliters produced after metolazone dose is given


Secondary Outcome Measures :
  1. Change in total body weight [ Time Frame: 12 to 23 hours ]
    Change in total body weight from baseline value measured prior to metolazone dose to value collected after metolazone dose

  2. Change in serum creatinine [ Time Frame: 12 to 23 hours ]
    Change in serum creatinine from baseline value collected prior to metolazone dose to value collected after metolazone dose

  3. Change in blood urea nitrogen [ Time Frame: 12 to 23 hours ]
    Change in blood urea nitrogen from baseline value collected prior to metolazone dose to value collected after metolazone dose

  4. Acute Kidney Injury [ Time Frame: 12 to 23 hours after metolazone dose ]
    Portion of patients with increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline

  5. Hypokalemia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with potassium level less than 4.0 mEq/L measured after metolazone dose is given

  6. Severe Hypokalemia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with potassium level less than 3.5 mEq/L measured after metolazone dose is given

  7. Hypomagnesemia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with magnesium level less than 2.0 mg/dL measured after metolazone dose is given

  8. Severe Hypomagnesemia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with magnesium level less than 1.5 mg/dL measured after metolazone dose is given

  9. Hyponatremia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with serum sodium level less than 135 mg/dL measured after metolazone dose is given

  10. Severe Hyponatremia [ Time Frame: 12 to 23 hours ]
    Proportion of patients with serum sodium level less than 125 mg/dL measured after metolazone dose is given



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746002


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Brent Reed, PharmD University of Maryland, College Park

Publications:
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Responsible Party: Brent Reed, Associate Professor, Pharmacy Practice and Science, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03746002     History of Changes
Other Study ID Numbers: HP-00082982
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Brent Reed, University of Maryland, Baltimore:
diuretic
metolazone
furosemide
Additional relevant MeSH terms:
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Furosemide
Heart Failure
Heart Diseases
Cardiovascular Diseases
Metolazone
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors