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Table 2 Primary and secondary endpoints

From: Nocturnal dexmedetomidine alleviates post–intensive care syndrome following cardiac surgery: a prospective randomized controlled clinical trial

Variables

Dexmedetomidine group (n = 251)

Placebo group (n = 257)

OR (95%CI)

P value

Primary endpoint

 PICS at 6-month after discharge #

54(21.5%)

80(31.1%)

0.793(0.665–0.945)

0.014

 Individual component of the primary end point

  Cognitive impairment by MMSE a

10(4.0%)

17(6.6%)

0.792(0.585–1.073)

0.186

  Psychological impairment by SAS and SDS b,c#

47(18.7%)

69(26.8%)

0.806(0.672–0.967)

0.029

  Physical impairment by Barthel index d

7(2.8%)

13(5.1%)

0.769(0.551–1.074)

0.188

Secondary endpoints

 Mortality in hospitalization, No (%)

2(0.8%)

1(0.4%)

1.521(0.306–7.522)

0.549

 Mortality within 6 months, No (%)

3(1.2%)

4(1.6%)

0.884(0.463–1.688)

0.727

 PICS at 3 months after discharge #

79 (31.5%)

110 (42.8%)

0.792(0.668–0.938)

0.008

 Cognitive impairment*

18(7.2%)

29(11.3%)

0.802(0.628–1.022)

0.11

 Psychological impairment*,#

58(23.1%)

84(32.7%)

0.799(0.671–0.951)

0.016

 Disability*,#

16(6.4%)

34(13.2%)

0.716(0.579–0.885)

0.01

 ICU stay

3.0(2.0,4.0)

3.0(2.0,4.0)

-

0.642

 Length of hospital stay

8(7.0,10.0)

8(7.0,11.0)

-

0.157

 Tracheal intubation time

13(9,16)

13(9,17)

-

0.346

 Retracheal intubation

2(0.8%)

5(1.9%)

0.704(0.437–1.134)

0.267

 Acute kidney injury

3(1.2%)

2(0.8%)

1.267(0.432–3.721)

0.634

Delirium

19 (7.6%)

31 (12.1%)

0.796(0.629–1.008)

0.089

 Postoperative atrial fibrillation

57 (22.7%)

80 (31.1%)

0.817(0.684–0.975)

0.033

 Safety outcomes

 Any adverse event occurred #

45(17.9%)

26(10.1%)

1.443(1.050–1.985)

0.011

 Hypotension after treatment initiation #

32(12.7%)

17(6.6%)

1.507(1.016–2.235)

0.019

 Bradycardia after treatment

17(6.8%)

12(4.7%)

1.236(0.795–1.923)

0.307

 Extra fluid intervention

13(5.2%)

6(2.3%)

1.625(0.834–3.168)

0.091

 Extra vasoconstrictor intervention

7(2.8%)

4(1.6%)

1.4(0.638–3.074)

0.34

  1. Data are given as means ± standard deviation (SD) or mean (IQR) for measurement variables and number of patients (n) and percentages (%) for categorical variables. OR odds ratio, CI confidence interval, PICS Post-intensive care syndrome, MMSE Mini-Mental State Examination, SAS Zung’s Self-Rating Anxiety Scale, SDS Self-Rating Depression Scale
  2. aThe Mini-Mental State Examination (MMSE) uses a 30-point scale to evaluate cognitive function based upon tests of patient orientation, concentration, attention, verbal memory, naming, and visuospatial skills. Scores of < 27 points are consistent with potential cognitive impairment
  3. bZung’s SAS is a 20-item questionnaire with scores ranging from 20–80 points. A score of > 50 points is consistent with potential generalized anxiety disorder
  4. cZung’s SDS contains 20 items using a 4-point Likert scale. The raw sum score of the SDS ranges from 20 to 80 but results are usually presented as the SDS Index, which is obtained by expressing the raw score is converted to 100 points scale. The SDS cut-off points for depression were > 50 based on literature
  5. dThe Barthel Index is a scale that assesses the ability to perform particular activities of daily living. This index consists of 10 tasks that are scored from 0 to 100, with higher scores corresponding to greater mobility. A score of < 80 is consistent with potential physical impairment
  6. *Rates of cognitive impairment, anxiety, and disability was at 3 months’ follow-up
  7. #Variables with significant difference, p < 0.05
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BMC Medicine

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