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Table 2 Safety evaluation

From: The low-dose colchicine in patients after non-CABG cardiac surgery: a randomized controlled trial

Variable

Colchicine

(n = 65)*

Placebo

(n = 62)

P value

Adverse outcomes (n, %)

 30-day mortality

0

0

–

 MV > 48 h

0

0

–

 Cardiac re-operation

0

0

–

 ECMO use

0

0

–

 IABP use

0

0

–

 Stroke

0

0

–

 CRRT use

0

0

–

PPS within POD14 (n, %)

2, 3.08%

11, 17.74%

0.006

Fever beyond first postoperative week

1, 1.54%

4, 6.45%

0.155

Pleuritic chest pain

0

4, 6.45%

0.037

Friction rub

1, 1.54%

7,11.29%

0.030

Pleural effusion

1, 1.54%

11, 17.74%

0.002

New or worsening pericardial effusion

0

0

–

Other outcomes (n, %)

 Infection

2, 3.08%

3, 4.84%

0.610

 Cardiac tamponade

0

0

–

 Constrictive pericarditis

0

0

–

ECG monitoring in ICU (n, %)

 Hyperacute T-wave

2, 3.08%

6, 9.68%

0.126

 ST-elevation

4, 6.16%

10, 16.13%

0.073

 Left/right bundle branch block

2, 3.08%

6, 9.68%

0.126

 Atrial fibrillation

1, 1.54%

2, 3.23%

0.531

 Other ventricular arrhythmias

2, 3.08%

6, 9.68%

0.126

Gastrointestinal disturbances (n, %)

6, 9.23%

0

0.014

Length of ICU stay (days)

3.0 (2.00–3.0)

2.0 (2.0–3.0)

0.112

Length of hospital stay (days)

15.0 (14.0–18.5)

16.0 (14.0–17.2)

0.692

MV time (hours)

6.0 (4.5–7.5)

7.0 (4.0–10.1)

0.156

  1. MV Mechanical ventilation, CRRT Continuous renal replacement therapy, Median (Interquartile range), ECMO Extracorporeal membrane oxygenation, IABP Intra-aortic balloon pump, PPS Post-pericardiotomy syndrome, ECG Electrocardiogram, POD14 Postoperative 14 days
  2. *6 patients who occurred gastrointestinal disturbances (diarrhea) before surgery and refused to continuously administrate colchicine in the colchicine group were included in the safety analysis