Table 3. Primary Outcome: 1-Year Change in Estimated Glomerular Filtration Ratea.
eGFR, mL/min per 1.73 m2 | Mean (95% CI) | Adjusted Between-Group Difference in Changeb (95% CI) | P Value | |
---|---|---|---|---|
Hydration Group (n = 311) |
Control Group (n = 308) |
|||
Prerandomization | 43.3 (42.1 to 44.4) | 43.6 (42.6 to 44.7) | ||
12 Months | 41.0 (39.5 to 42.6) | 41.7 (40.3 to 43.1) | ||
Change | −2.2 (−3.3 to −1.1)c | −1.9 (−2.9 to −0.9)c | −0.3 (−1.8 to 1.2) | .74 |
Abbreviation: eGFR, estimated glomerular filtration rate.
Analyses exclude 12 patients who died during the 12-month trial period (5 in the hydration group; 7 in the control group); all analyses followed the intention-to-treat principle. Fully conditionally specified models were used to impute missing 12-month eGFR values for 29 patients.
The adjusted between-group difference in eGFR change was analyzed using linear regression, adjusted for age (in years), sex, obesity (body mass index ≥30 [calculated as weight in kilograms divided by height in meters squared]), current smoker, presence of diabetes, urinary albumin (mg/d) (log-transformed), and use of the following medications: an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, diuretic, β-blocker, calcium channel blocker, and statin.
The mean change in eGFR (12-month value minus the prerandomization value) was calculated within each of 20 imputed data sets, and the mean was calculated using the imputed data set means.