Table 5.
Adverse events
| Adverse Event | Placebo N=54 |
Sodium Bicarbonate N=55 |
|---|---|---|
| Serious adverse events | ||
| No. of hospitalizations, N (%) | 6 (11.1) | 6 (10.9) |
| Reasons for hospitalizations | ||
| Infections | 1 (1.9) | 1 (1.8) |
| Volume overload | 1 (1.9) | 0 |
| MI/stroke | 1 (1.9) | 1 (1.8) |
| Acute on chronic renal failure | 1 (1.9) | 0 |
| Surgery | 2 (3.7) | 0 |
| Ileus | 0 | 1 (1.8) |
| High/low glucose levels | 0 | 2 (3.6) |
| Loss of consciousness | 0 | 1 (1.8) |
| No. of deaths, N (%) | 1 (1.9) | 0 |
| Deaths related to the study | 0 | 0 |
| Chronic dialysis initiation, N (%) | 1 (1.9) | 1 (1.8) |
| Adverse events | ||
| New edema, N (%) | 1 (2.2) | 1 (2.3) |
| Increase in diuretic therapy, N (%) | 7 (12.9) | 8 (14.5) |
| Increase in antihypertensive therapy, N (%) | 12 (22.2) | 11 (20.0) |
| High serum bicarbonate level (>28 mEq/L), N (%) | 1 (1.9) | 13 (23.6)a |
| Low serum bicarbonate level (<20 mEq/L), N (%) | 8 (14.8) | 4 (7.3) |
P value <0.05.