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Table 3 Primary and secondary endpoints

From: Randomized controlled trial of liberal vs. standard fasting instructions in percutaneous cardiac procedures

Outcomes

Ad libitum clears

Usual Care

P-Value

Difference

95% CI for difference

Patient Satisfaction Score—median (IQR)

12

(6, 17)

10

(5, 15)

0.18

2

(-1, 4)

 Thirst

5

(2, 7)

4

(2, 5)

0.17

0

(0, 2)

 Hunger

2.5

(0, 6)

2

(0, 5)

0.87

0

(0, 0)

 Headache

0

(0, 0)

0

(0, 0)

0.46

0

(0, 0)

 Nausea

0

(0, 0)

0

(0, 0)

0.32

0

(0, 0)

 Lightheaded

0

(0, 0)

0

(0, 0)

0.84

0

(0, 0)

 Anxious

3.5

(0, 7)

3

(0, 5)

0.35

0

(0, 1)

Change in Creatinine – n (%)

59

65.6%

58

63.7%

0.8

1.9%

(-12.1%, 15.8%)

Change in Creatinine (POST–PRE)—median (IQR)

-0.1

(-0.2, 0.02)

-0.1

(-0.2, -0.02)

0.27

-0.03

(-0.1, 0.02)

Vasopressor—n (%)

56

62.2%

55

60.4%

0.81

1.8%

(-12.4%, 16.0%)

PONV (rescue medication)

4

4.4%

4

4.4%

1

0.05%

(-5.9%, 6.0%)

PLOS [HRS]—median (IQR)

21.3

(7.9, 25.8)

21.3

(6.2, 25.2)

0.5

0.6

(-1.1, 2.6)

Safety Endpoints

 Intra-op Vomiting/ Regurgitation—n(%)

0

0%

0

0%

N/A

N/A

N/A

 Post Op O2 needed at 24 h) – n (%)

8

8.9%

7

7.7%

0.77

1.2%

(-6.4%, 9.2%)

 Evidence of Aspiration—n(%)

0

0%

0

0%

N/A

N/A

N/A

  1. Number of patients with characteristic is followed by percentage or mean (std) or median (IQR) as appropriate
  2. PONV Postoperative nausea or vomiting, PLOS Postoperative length of stay