Phase 4
Completed N=57
Loop Diuretics Administration and Acute Heart Failure
Source: ClinicalTrials.gov NCT01441245 ↗Enrolled (actual)
57
Serious AEs
40.4%
Results posted
Feb 2016
Primary outcomePrimary: Evaluation of Mean Urine Output Volume During the Infusion Period — 2505; 2140 mL — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Mean Urine Output Volume During the Infusion Period |
2505; 2140 | 0.04 sig |
| PRIMARY Evaluation of Renal Function in Terms of Creatinine Levels at Discharge |
1.78; 1.51 | 0.01 sig |
| PRIMARY Evaluation of Renal Function in Terms of Changes in Creatinine Levels |
-0.10; -0.50 | 0.02 sig |
| PRIMARY Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment |
679; 949 | 0.04 sig |
| PRIMARY Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge |
-525; -148 | 0.03 sig |
| PRIMARY Evaluation of Renal Function in Terms of Changes in GFR |
-3.18; -1.93 | 0.01 sig |
| PRIMARY Evaluation of Renal Function in Terms of GFR Values at Discharge |
44.8; 46.7 | 0.05 |
| SECONDARY Length of Hospitalization in the Two Groups |
80; 44 | <0.01 sig |
| SECONDARY Dopamine Infusion During Hospitalization |
50; 26 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Patients took part in the random sample selection if they met the diagnostic criteria for acute decompensated HF.
- Patients with primary diagnosis of ADHF, volume overload with cardia dilation and LVEF 100 pg/ml.
Exclusion Criteria
- Patients were excluded if they had received more than 2 IV doses of furosemide or any continuous infusion of furosemide 1 month before randomization
- If they had end-stage renal disease or the need for renal replacement therapy, isolated diastolic dysfunction.
- Recent myocardial infarction
Data sourced from ClinicalTrials.gov (NCT01441245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.