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Table 2 Primary and secondary clinical outcomes

From: Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial

 

Category

SOC

TPE

p between groups

   

0 h

6 h

24 h

p

 

0 h

6 h

24 h

p

 

0 h

6 h

24 h

Primary

NE dose (μg/kg/min)

 

0.582 (0.458–0.84)

0.482 (0.363–0.835)

0.362 (0.244–0.763)

0.052

 

0.598 (0.549–0.867)

0.335 (0.208–0.444)

0.183 (0.067–0.337)

 < 0.0001

–

0.626

0.004

0.012

Absolute ΔNE dose 0–6 h (μg/kg/min)

 − 0.08 (− 0.242 to 0.06)

–

–

–

–

 − 0.317 (− 0.554 to − 0.133)

–

–

–

–

0.003

–

–

–

Relative ΔNE dose 0–6 h (%)

 − 9.7 (− 31.7 to 13.8)

–

–

–

–

 − 47.5 (− 71.6 to − 26.1)

–

–

–

–

0.001

–

–

–

Secondary

Absolute ΔNE dose 0–24 h (μg/kg/min)

 − 0.121 (− 0.306 to 0.095)

–

–

–

–

 − 0.463 (− 0.725 to − 0.314)

–

–

–

–

0.001

–

–

–

Relative ΔNE dose 0–24 h (%)

 − 24 (− 63.2 to 11)

–

–

–

–

 − 71.5 (− 89 to − 58.4)

–

–

–

–

 < 0.0001

–

–

–

VIS Score (points)

–

61 (46–85)

62 (41–146)

37 (24–120)

0.227

–

60 (55–87)

31 (21–43)

23 (13–38)

 < 0.0001

–

0.698

 < 0.0001

0.028

Absolute ΔVIS Score 0–6 h (points)

 − 4 (− 24 to 37)

–

–

–

–

 − 39 (− 58 to − 16)

–

–

–

–

0.0001

–

–

–

Relative ΔVIS Score 0–6 h (%)

 − 6 (− 36.4 to 39.5)

–

–

–

–

 − 53.6 (− 73.4 to − 30.7)

–

–

–

–

 < 0.0001

–

–

–

Absolute ΔVIS Score 0–24 h (points)

 − 14 (− 31 to 61)

–

–

–

–

 − 42 (− 62 to − 29)

–

–

–

–

0.003

–

–

–

Relative ΔVIS Score 0–24 h (%)

 − 25.9 (− 63.2 to 62)

–

–

–

–

 − 70.7 (− 78.7 to − 53.6)

–

–

–

–

0.002

–

–

–

Mean SOFA Score d1-9 (points)

19 (15–24)

–

–

–

–

17 (12–21)

–

–

–

–

0.194

–

–

–

28-day Mortality (%)

10/20 (50)

–

–

–

–

8/20 (40)

–

–

–

–

0.437

–

–

–

Lactate (mmol/l)

–

4.4 (2.6–6.9)

4.3 (2.1–6.1)

3.1 (1.9–6.7)

0.628

–

4 (2.6–5.9)

4.1 (2.1–5.9)

1.7 (1.3–3.1)

0.014

–

0.644

0.664

0.055

pO2/FiO2 (mmHg)

–

165 (74–227)

133 (100–205)

163 (91–216)

0.925

–

132 (98–278)

158 (125–241)

146 (119–259)

0.833

–

0.658

0.551

0.891

Fluid balance (ml)

–

–

 + 1720 (867–2581)

 + 3675 (1129–6591)

0.025

–

–

 + 2048 (567–3054)

 + 3903 (294–5408)

0.008

–

–

0.682

0.452

SVV (%)

–

15 (12–23)

16 (14–23)

–

0.48

–

17 (12–23)

10 (8–16)

–

0.135

–

0.908

0.069

–

GEDI (ml/m2)

–

770 (650–955)

777 (710–1004)

–

0.501

–

718 (599–788)

712 (666–937)

–

0.186

–

0.127

0.509

–

ELWI (ml/kg)

–

12 (7–19)

15 (8–21)

–

0.14

–

11 (9–19)

12 (9–16)

–

0.277

–

0.991

0.43

–

SVRI (dyn*s*cm-5*m2)

–

1374 (895–1762)

1395 (952–2148)

–

0.122

–

1432 (1229–1691)

1171 (882–1374)

–

0.193

–

0.521

0.563

–

CI (l/min/m2)

–

3.6 (2.2–4.6)

3.5 (2.3–4.7)

–

0.818

–

3.1 (2.8–4.1)

3.6 (3.2–4)

–

0.31

–

0.484

0.921

–

Vasopressor free days (days)

11 ± 11

–

–

–

–

11 ± 10

–

–

–

–

0.976

–

–

–

Ventilator free days (days)

10 ± 5

–

–

–

–

6 ± 8

–

–

–

–

0.209

–

–

–

RRT free days (days)

7 ± 11

–

–

–

–

10 ± 12

–

–

–

–

0.491

–

–

–

ICU free days (days)

4 ± 6

–

–

–

–

3 ± 5

–

–

–

–

0.512

–

–

–

  1. Shown are primary and secondary clinical outcomes for patients receiving standard of care treatment (SOC) as well as patients receiving additive therapeutic plasma exchange (TPE). Endpoints are compared both longitudinally at 0, 6 and 24 h following randomization as well as between SOC and TPE groups
  2. CI cardiac index, ELWI extravascular lung water index, GEDI global end-diastolic index, ICU intensive care unit, MAP mean arterial pressure, NE norepinephrine, RRT renal replacement therapy, SOFA Sequential Organ Failure Assessment, SVV stroke volume variation, SVRI systemic vascular resistance index, VIS vasoactive-inotropic score