|
Patient demographic and clinical characteristics |
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| Characteristic |
Remifentanil |
Fentanyl |
|
|
||
| Number of patients treated (SP) |
115 |
81 |
| Open label pilot patients |
12 |
6 |
| Open label practice patients |
26 |
0 |
| ITT population |
77 |
75 |
| Cardiac postsurgical |
46 (60%) |
45 (60%) |
| General postsurgical |
25 (32%) |
26 (35%) |
| Medical |
6 (8%) |
4 (5%) |
| Normal renal function* |
68 (59%) |
48 (59%) |
| Mild renal impairment† |
47 (41%) |
33 (41%) |
| Mean SAPS II (SD) |
SP 27.9 (8.7); ITT 28.2 (8.8) |
SP 27.6 (8.6); ITT 27.7 (8.8) |
| Mean age [years] (SD) |
SP 61.3 (13.8); ITT 61.5 (13.4) |
SP 59.3 (13.6); ITT 58.7 (13.9) |
| Sex |
||
| Male |
SP 81 (70%); ITT 55 (71%) |
SP 56 (69%); ITT 52 (69%) |
| Female |
SP 34 (30%); ITT 22 (29%) |
SP 25 (31%); ITT 23 (31%) |
| Mean height (cm; SD) |
SP 169.8 (9.5); ITT 170.4 (9.1) |
SP 169.7 (9.8); ITT 169.6 (9.6) |
| Mean weight (kg; SD) |
SP 76.9 (13.9); ITT 77.2 (12.7) |
SP 74.9 (13.0); ITT 74.8 (13.9) |
|
Renal function was assessed by predicting the patient's creatinine clearance (CLcr), as described by Cockcroft and Gault [32]. *Normal renal function was defined as a predicted CLcr >80 ml/min. †Mild renal impairment was defined as a predicted CLcr of 50–80 ml/min. ITT, intent to treat population; SD, standard deviation; SP, safety population. | ||
Muellejans et al. Critical Care 2004 8:R1 doi:10.1186/cc2398 |
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