Frequencies and Effect Sizes for Postsurgical Serum Sodium Level Following Intention-To-Treat (ITT) Analysisa
| Ad-lib | Strict fluid restriction | Moderate fluid restriction | Overall fluid restriction | Overall | ||||||||||
| (N = 94) | (N = 62) | (N = 39) | (N = 101) | (N = 195) | ||||||||||
| Mean (SD) | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | |
| Serum sodium level (mEq/L)b | ||||||||||||||
| Nadirc | 135 (5.56) | 137 (3.68) | 1.81 | 0.34–3.27 | .02* | 136 (5.01) | 1.38 | –0.59–3.34 | .17 | 137 (4.22) | 1.64 | 0.24–3.04 | .02* | 136 (4.97) |
| Daily averaged | 139 (3.09) | 139 (2.56) | 0.47 | –0.43–1.37 | .31 | 139 (2.60) | 0.85 | –0.19–1.89 | .11 | 139 (2.57) | 0.62 | –0.19–1.42 | .13 | 139 (2.84) |
| Ad-lib | Strict fluid restriction | Moderate fluid restriction | Overall fluid restriction | Overall | ||||||||||
| (N = 94) | (N = 62) | (N = 39) | (N = 101) | (N = 195) | ||||||||||
| Mean (SD) | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | |
| Serum sodium level (mEq/L)b | ||||||||||||||
| Nadirc | 135 (5.56) | 137 (3.68) | 1.81 | 0.34–3.27 | .02* | 136 (5.01) | 1.38 | –0.59–3.34 | .17 | 137 (4.22) | 1.64 | 0.24–3.04 | .02* | 136 (4.97) |
| Daily averaged | 139 (3.09) | 139 (2.56) | 0.47 | –0.43–1.37 | .31 | 139 (2.60) | 0.85 | –0.19–1.89 | .11 | 139 (2.57) | 0.62 | –0.19–1.42 | .13 | 139 (2.84) |
Abbreviations: ED, estimated difference; OR, odds ratio; 95% CI, 95% confidence interval; POD, postoperative day.
aPostsurgical sodium serum level and kidney condition were reported for the 195 patients following pituitary surgery, stratified by randomization group. Analyses were conducted following ITT approach.
bSerum sodium levels were reported by mean (SD). The estimated difference in serum sodium nadir and mean (along with associated 95% CI and P value) was calculated using an unpaired t-test for each fluid restriction group vs control group.
cSerum sodium nadir was defined as the lowest serum sodium level between POD3 and POD 14.
dSerum sodium daily average was calculated by taking the daily average of serum sodium level between POD3 and POD14.
*P < .1.
**P < .05.
***P < .001.
Frequencies and Effect Sizes for Postsurgical Serum Sodium Level Following Intention-To-Treat (ITT) Analysisa
| Ad-lib | Strict fluid restriction | Moderate fluid restriction | Overall fluid restriction | Overall | ||||||||||
| (N = 94) | (N = 62) | (N = 39) | (N = 101) | (N = 195) | ||||||||||
| Mean (SD) | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | |
| Serum sodium level (mEq/L)b | ||||||||||||||
| Nadirc | 135 (5.56) | 137 (3.68) | 1.81 | 0.34–3.27 | .02* | 136 (5.01) | 1.38 | –0.59–3.34 | .17 | 137 (4.22) | 1.64 | 0.24–3.04 | .02* | 136 (4.97) |
| Daily averaged | 139 (3.09) | 139 (2.56) | 0.47 | –0.43–1.37 | .31 | 139 (2.60) | 0.85 | –0.19–1.89 | .11 | 139 (2.57) | 0.62 | –0.19–1.42 | .13 | 139 (2.84) |
| Ad-lib | Strict fluid restriction | Moderate fluid restriction | Overall fluid restriction | Overall | ||||||||||
| (N = 94) | (N = 62) | (N = 39) | (N = 101) | (N = 195) | ||||||||||
| Mean (SD) | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | ED | 95% CI | P value | Mean (SD) | |
| Serum sodium level (mEq/L)b | ||||||||||||||
| Nadirc | 135 (5.56) | 137 (3.68) | 1.81 | 0.34–3.27 | .02* | 136 (5.01) | 1.38 | –0.59–3.34 | .17 | 137 (4.22) | 1.64 | 0.24–3.04 | .02* | 136 (4.97) |
| Daily averaged | 139 (3.09) | 139 (2.56) | 0.47 | –0.43–1.37 | .31 | 139 (2.60) | 0.85 | –0.19–1.89 | .11 | 139 (2.57) | 0.62 | –0.19–1.42 | .13 | 139 (2.84) |
Abbreviations: ED, estimated difference; OR, odds ratio; 95% CI, 95% confidence interval; POD, postoperative day.
aPostsurgical sodium serum level and kidney condition were reported for the 195 patients following pituitary surgery, stratified by randomization group. Analyses were conducted following ITT approach.
bSerum sodium levels were reported by mean (SD). The estimated difference in serum sodium nadir and mean (along with associated 95% CI and P value) was calculated using an unpaired t-test for each fluid restriction group vs control group.
cSerum sodium nadir was defined as the lowest serum sodium level between POD3 and POD 14.
dSerum sodium daily average was calculated by taking the daily average of serum sodium level between POD3 and POD14.
*P < .1.
**P < .05.
***P < .001.
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