Table 3 Safety and exploratory endpoints
From: Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial
Natriuresis-guided therapy | SOC | P value | |
|---|---|---|---|
Safety endpoints | |||
Serious adverse events (% (n)) | 40 (60) | 44 (70) | 0.5799 |
Adverse events (% (n)) | 57 (86) | 60 (96) | 0.7180 |
Renal safety events | |||
Doubling of serum creatinine at 24 h from baseline (% (n)) | 0 (0) | 1 (1) | 1.0000 |
Doubling of serum creatinine at 48 h from baseline (% (n)) | 1 (1) | 1 (2) | 1.0000 |
Worsening HF (% (n)) | 6 (9) | 9 (15) | 0.3689 |
True worsening renal function (% (n)) | 1 (1) | 1 (2) | 1.0000 |
Exploratory endpoints | |||
72 h natriuresis (mmol) | 832 ± 323 | 746 ± 350 | 0.0706 |
72 h diuresis (ml) | 8,720 [7,085–10,775] | 8,255 [6,312.5–10,050] | 0.1104 |
Fluid balance (ml) | |||
At 24 h | −2,833 ± 1,673 | −2,380 ± 1,573 | 0.0218 |
At 48 h | −4,728 ± 2,318 | −4,110 ± 2,137 | 0.0297 |
At 72 h | −6,216 ± 3,000 | −5,728 ± 2,825 | 0.2400 |
Weight change from baseline (kg) | |||
At 24 h | −1.2 [−2.4–0.3] | −0.4 [−1.9–0.1] | 0.1103 |
At 48 h | −3.5 [−5.0–1.6] | −3.2 [−4.4–1.0] | 0.1505 |
At 72 h | −4.0 [−6.1–2.2] | −3.0 [−4.9–0.7] | 0.1529 |
Percentage change in NT-proBNP (%) | |||
At 24 h | 1 [−24–32] | 3 [−15–26] | 0.5103 |
Hypokalemia (K < 3.5 mmol l−1) (% (n)) | 23 (35) | 15 (24) | 0.0849 |
Hyperkalemia (K > 5.5 mmol l−1) (% (n)) | 2 (3) | 6 (10) | 0.1136 |
