drugset / Trial / NCT01441245

Loop Diuretics Administration and Acute Heart Failure

NCT01441245 ↗

Phase 4 Completed 57 enrolled University of Siena
RandomizedParallel-groupDouble-blindTreatment

Summary

Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion and systemic fluid overload. In theory, continuous infusion should allow for a more consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the neurohormonal activation. This should lead to renal function improvement and BNP decrease.

Timeline

Start
2010-04
Primary completion
2016-06
Completion
2017-12-28

Outcome

Mixed primary results

registry MEAN Urine Output in cIV: 2505 (Standard Deviation 796) mL NCT01441245 ↗

registry MEAN Urine Output in iIV: 2140 (Standard Deviation 468) mL NCT01441245 ↗

registry Urine Output in cIV vs Urine Output in iIV; p = 0.04; t-test, 2 sided NCT01441245 ↗

registry MEAN Creatinine at Discharge in cIV: 1.78 (Standard Deviation 0.5) mg/dL NCT01441245 ↗

registry MEAN Creatinine at Discharge in iIV: 1.51 (Standard Deviation 0.3) mg/dL NCT01441245 ↗

registry Creatinine at Discharge in cIV vs Creatinine at Discharge in iIV; p = 0.01; t-test, 2 sided NCT01441245 ↗

registry MEAN BNP Change in cIV: -525 (Standard Deviation 615) pg/mL NCT01441245 ↗

registry MEAN BNP Change in iIV: -148 (Standard Deviation 463) pg/mL NCT01441245 ↗

registry BNP Change in cIV vs BNP Change in iIV; p = 0.03; t-test, 2 sided NCT01441245 ↗

paper There were three co-primary endpoints assessed from admission to discharge: the mean paired changes in serum creatinine, estimated glomerular filtration rate (eGFR), and reduction in B-type natriuretic peptide (BNP). PMID 24974232 ↗

paper The continuous infusion arm had a greater reduction in BNP over the hospital course, (-576 ± 655 versus -181 ± 527 pg/ml P = 0.02). PMID 24974232 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified — Intravenous

Indications