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. 2003 Nov 20;8(1):R1–R11. doi: 10.1186/cc2398

Table 2.

Patient demographic and clinical characteristics

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.

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