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Patient demographic and clinical characteristics (safety population) |
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| Degree of renal impairment |
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| Characteristic |
Normal/mild |
Moderate/severe |
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|
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| Number of patients treated |
10 |
30 |
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| Reason for ICU admittance |
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| Cardiac postsurgical |
4 (40%) |
7 (23%) |
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| General postsurgical |
0 |
10 (33%) |
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| Medical |
6 (60%) |
13 (44%) |
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| Respiratory |
4 (40%) |
8 (27%) |
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| Sepsis |
0 |
3 (10%) |
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| Cardiovascular |
1 (10%) |
1 (3%) |
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| Trauma |
1 (10%) |
0 |
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| Haematological |
0 |
1 (3%) |
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| Mean SAPS II (range) |
41.0 (31–57) |
53.2 (16–91) |
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| Mean CLcr (ml/min) at screening (range) |
62.9 (44–84) |
13.7 (0–49) |
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| Mean renal dysfunction score at screening‡ (range) |
2.3 (0–3) |
4.3 (1–5) |
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| Renal replacement therapy |
0 |
14 (47%) |
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| Mean baseline SAS score (range) |
2.9 (2–4) |
2.4 (2–4) |
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| Mean baseline PI score (range) |
1.2 (1–2) |
1.1 (1–3) |
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| Mean baseline RR (breaths/min; range) |
15.6 (10–22) |
14.7 (0–39) |
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| Mean baseline MAP (mmHg; range) |
79.0 (53–105) |
78.3 (56–135) |
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| Mean baseline HR (beats/min; range) |
85.6 (61–126) |
94.7 (62–128) |
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| Mean age (years; range) |
68.6 (54–78) |
65.7 (31–81) |
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| Sex |
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| Male |
9 (90%) |
22 (73%) |
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| Female |
1 (10%) |
8 (27%) |
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| Mean height (cm; range) |
173.2 (157–180) |
167.5 (120–188) |
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| Mean weight (kg; range) |
79.6 (68–96) |
75.6 (38.3–110) |
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Renal function was assessed by estimating the patient's creatinine clearance (CLcr), as described under Methods. Normal renal function/mild renal impairment was defined as an estimated CLcr ≥ 50 ml/min. Moderate/severe renal impairment was defined as an estimated CLcr <50 ml/min. ‡Logistic Organ Dysfunction Score [18]. HR, heart rate; ICU, intensive care unit; MAP, mean arterial pressure; PI, Pain Intensity (scale); RR, respiratory rate; SAPS, Simplified Acute Physiology Score [23]; SAS, Sedation–Agitation Scale. | |||
Breen et al. Critical Care 2004 8:R21 doi:10.1186/cc2399 |
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