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Table 2 Primary, Secondary, and Safety Outcomes in cluster randomized analyses of the POINCARE-2 trial

From: Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial

 

Control group % [95% CI]b

Strategy group % [95% CI]b

Crude effect of strategy

Adjusted effect of strategya

Median (IQR)c

Median (IQR)c

Model (part)

Exp(parameter) [95% CI]

p-value

Model (part)

Exp(parameter) [95% CI]

p-value

Primary outcome

60-day mortality rateb

33.9 [29.6–38.2]

30.5 [26.2–34.8]

MP

 

RR

0.90 [0.75–1.08]

0.26

MP

 

RR

0.90 [0.75–1.08]

0.99

Secondary outcomes

28-day mortality rateb

26.7 [22.7–30.7]

21.7 [17.8–25.6]

MP

 

RR

0.77 [0.56–1.06]d

0.26d

MP

 

RR

0.77 [0.56–1.06]d

> 0.99d

In-hospital mortality rateb

32.6 [28.4–36.9]

29.6 [25.3–33.9]

MP

 

RR

0.91 [0.68–1.21]d

> 0.99d

MP

 

RR

0.91 [0.68–1.21]d

> 0.99d

Mechanical ventilator-free daysc

9.0 [0.0–18.0]

9.0 [0.0–17.0]

ZINB

(NB)

MF

1.01 [0.91–1.12]d

> 0.99d

ZINB

(NB)

MF

1.01 [0.91–1.12]d

> 0.99d

(ZI)

OR

0.91 [0.57–1.46]d

> 0.99d

(ZI)

OR

0.91 [0.57–1.46]d

> 0.99d

Vasopressor-free daysc

17.0 [7.0–24.0]

17.0 [8.0–26.0]

ZINB

(NB)

MF

1.03 [0.96–1.10]d

> 0.99d

ZINB

(NB)

MF

1.03 [0.96–1.10]d

> 0.99d

(ZI)

OR

0.84 [0.42–1.68]d

> 0.99d

(ZI)

OR

0.84 [0.42–1.68]d

> 0.99d

Renal replacement therapy-free daysc

23.0 [11.0–47.5]

23.0 [11.0–49.0]

ZIPoi

(Poi)

MF

0.996 [0.97–1.03]d

> 0.99d

ZIPoi

(Poi)

MF

0.996 [0.97–1.03]d

> 0.99d

(ZI)

OR

1.11 [0.40–3.11]d

> 0.99d

(ZI)

OR

1.11 [0.40–3.11]d

> 0.99d

Safety outcomes

Arterial hypotensionb

77.8 [74.0–81.5]

71.6 [67.4–75.9]

MP

 

RR

0.94 [0.85–1.03]

0.16

MP

 

RR

0.94 [0.85–1.03]

0.39

At least one episode of hypernatremia> 155 mmol/lb

2.3 [1.0–3.7]

5.8 [3.6–8.0]

LB

 

RR

2.72 [1.23–6.00]

0.01

LB

 

RR

2.72 [1.23–6.00]

0.02

At least one episode of hypokalemia < 2.8 mmol/lb

7.6 [5.2–10.0]

7.2 [4.8–9.6]

LB

 

RR

1.02 [0.61–1.72]

0.93

LB

 

RR

1.02 [0.61–1.72]

0.60

Renal damage b,e

20.3 [16.6–24.0]

23.5 [19.5–27.6]

LB

 

RR

1.16 [0.90–1.50]

0.25

LB

 

RR

1.16 [0.90–1.50]

0.24

Myocardial infarctionb

0.4 [0.0–1.0]

1.15 [0.2–2.2]

LB

 

RR

1.82 [0.23–14.15]

0.57

LB

 

RR

1.82 [0.23–14.15]

0.61

Mesenteric ischemiab

0.6 [0.0–1.4]

0.2 [0.0–0.7]

LB

 

RR

0.36 [0.04–3.49]

0.38

LB

 

RR

0.36 [0.04–3.49]

0.45

  1. CI Confidence interval, IQR Interquartile range, MP Mixed modified Poisson, RR Risk ratio, ZINB Zero-inflated negative binomial mixed, NB Negative binomial part, MF Multiplicative factor, ZI Zero-inflated part, ZIPoi Zero-inflated Poisson mixed, Poi Poisson part, LB Log-binomial mixed
  2. aAdjusted for the following baseline characteristics: age, main cause of admission (recoded as CNS injury vs. other causes of admission), McCabe score, SAPS II at day 1
  3. bBinary outcomes: log-binomial (modified Poisson) mixed models were used and “exp(parameter)” are estimations of RR
  4. cNumeric outcomes: modeled with zero-inflated negative binomial (Poisson) mixed models which combine a logistic regression and a negative binomial (Poisson respectively) model and “exp(parameter)” are odds ratios of excess of zeros for the zero-inflated part (logistic) and multiplicative factor for the counting part (negative binomial/Poisson)
  5. dBonferroni correction was used: Confidence intervals according to α = 5/22 = 0.23% and p-values by a multiplying a coefficient of 22
  6. eRenal damage was defined by worsening RIFLE between Day 3 and Day 14 as compared with the higher RIFLE observed on Day 1 or Day 2. For renal damage, analyses were conducted within the subsample of at-risk patients (i.e., in 883/905 patients not classified as RIFLE “End Stage Kidney Disease” at Day 2)