Proefschrift Kerklaan

Chapter 7

Supplementary Table 4. Protocol for scoring of infections

Data export All patients receiving antimicrobial agents were identified by the data manager, who provided an export of all patient numbers with all the information on antimicrobial agents given as well as the duration of such treatment. Identification of patients with infections The infectious disease specialists, who were blinded for treatment allocation, selected all patients receiving antimicrobial agents for more than 48h, after excluding all patients who received prophylaxis. Each patient who fulfilled the criteria for infection, as well as the type of infection, was identified as such based on thorough review of the medical record 6 . Patients for whom antimicrobials were initiated prior to PICU admission or within the first 48 hours of admission while the criteria for infection were fulfilled, were labeled as“ having an infection upon admission ”. When antimicrobial agents were initiated after randomization and beyond the first 48 hours in the PICU, and were given for more than 48 hours while the criteria for infection were fulfilled, the patient was labeled as “ having a new infection ” 6 .

1.

2.

Supplementary Table 5. Logistic regression and Cox proportional hazards analyses OR or HR unadjusted (95% CI) Late PN vs. Early PN P-value unadjusted OR or HR adjusted* (95% CI) Late PN vs. Early PN

P-value adjusted

Primary Outcomes Odds for New Infection

0.53 (0.39-0.71) 1.14 (1.02-1.27)

< 0.001 0.48 (0.35-0.66)

< 0.001 < 0.001

Likelihood of Earlier Live Discharge from PICU

0.01

1.23 (1.11-1.37)

Safety Outcomes Odds for Death Within 8 days in PICU

0.91 (0.48-1.71) 0.89 (0.55-1.45) 0.84 (0.53-1.32) 0.77 (0.49-1.19)

0.76 0.64 0.44 0.23

0.73 (0.34-1.51) 0.73 (0.42-1.28) 0.72 (0.43-1.19) 0.64 (0.39-1.05)

0.39 0.27 0.20 0.07

During PICU Stay

During Hospital Stay

Within 90 days after enrollment Secondary Efficacy Outcomes Likelihood of Earlier Live Weaning from Mechanical Ventilatory Support Likelihood of Earlier Live Discharge from Index Hospital Likelihood of Earlier Live Discharge from Hospital (Index and Transferral Hospital)

1.11 (1.00-1.24)

0.04

1.19 (1.07-1.32)

0.001

Odds for Renal Replacement Therapy 0.69 (0.37-1.26)

0.23 0.01

0.49 (0.24- 0.96) 1.19 (1.07-1.33)

0.03

1.14 (1.03-1.27)

0.001

1.14 (1.02-1.27)

0.02

1.21 (1.08-1.34)

< 0.001

All duration of care outcomes were censored at 90 days with non-survivors censored at 91 days. OR=Odds Ratio, HR=Hazard Ratio, PN=Parenteral Nutrition, 95% CI= 95% confidence intervals, PICU=Pediatric Intensive Care Unit * Adjusted for the following risk factors: center, age group, diagnosis group, PELOD score (first 24h) 7 and STRONGkids category 1

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