dose-ahf d iuretic o ptimization s trategies e valuation in a cute h eart f ailure

DOSE-AHFDOSE-AHF

DDiuretic iuretic OOptimization ptimization SStrategies trategies EEvaluation valuation in in AAcute cute HHeart eart FFailureailure

Duke Heart Failure ResearchDuke Heart Failure Research

Pager: 970-0736Pager: 970-0736

PurposePurpose

Double blinded controlled study to Double blinded controlled study to evaluate safety and efficacy of high evaluate safety and efficacy of high intensification diuretics vs. low intensification diuretics vs. low intensification diuretics in Acute intensification diuretics in Acute Decompensated Heart Failure (ADHF) and Decompensated Heart Failure (ADHF) and IV continuous vs. intermittent bolus q12 IV continuous vs. intermittent bolus q12 hours hours

– Double blinded study meaning subjects, MD, and research team are unaware of what treatment is being received.

Inclusion CriteriaInclusion Criteria

ADHF with 24 hrs of ADHF with 24 hrs of admission admission

Potential need for IV Potential need for IV loop diuretics for next loop diuretics for next 48hrs 48hrs

InterventionsInterventions

Randomized to 1 of 4

combinationtreatments

Low dose IV Furosemide

by continuous infusion

Low dose IV Furosemide

by intermittent bolus q12 hrs

High dose IV Furosemide

by continuous infusion

High dose IV Furosemide

by intermittent bolus q12 hrs

Subjects receive BOTH IV bolus q12 hrs AND continuous infusion; only one contains the active study drug Furosemide

InterventionsInterventions

Open label Furosemide may be used at the Open label Furosemide may be used at the discretion of the physician. discretion of the physician. – If the MD feels the patient is not being diuresed If the MD feels the patient is not being diuresed

effectively, additional Furosemide may be given effectively, additional Furosemide may be given in addition to study drug.in addition to study drug.

Nursing RolesNursing RolesStart at the same timeStart at the same time::

– Continuous infusion (volume of 250 ml) with a flow rate of 10 ml/hr Continuous infusion (volume of 250 ml) with a flow rate of 10 ml/hr

– Bolus (volume of 50 ml) with a flow rate of 40.2 ml/hr Bolus (volume of 50 ml) with a flow rate of 40.2 ml/hr

After 12 hoursAfter 12 hours::

– Hang the next bolus (volume of 50 ml) with a flow rate of 40.2 Hang the next bolus (volume of 50 ml) with a flow rate of 40.2 ml/hr ml/hr

Ask patients to complete the Visual Analog Scales (VAS*): Global Ask patients to complete the Visual Analog Scales (VAS*): Global Well-being and Dyspnea at specific intervals: Well-being and Dyspnea at specific intervals: 6 hrs and 12 hrs after 6 hrs and 12 hrs after initiation of study drug infusion and daily for 4 daysinitiation of study drug infusion and daily for 4 days

Only 1 IV line necessary; both drugs can run through same IV Only 1 IV line necessary; both drugs can run through same IV

*Found in patient’s chart box.*Found in patient’s chart box.

OutcomesOutcomes

Why is this study being done?Why is this study being done?

– SAFETYSAFETY: Determine the change in serum : Determine the change in serum creatinine from time of randomization to 72 creatinine from time of randomization to 72 hrs hrs

– EFFICACYEFFICACY: As indicated by the Global Well-: As indicated by the Global Well-being and Dyspnea Visual Analog Scales being and Dyspnea Visual Analog Scales (VAS) (VAS)