Paediatric Early versus late PArenteral Nutrition In Critical illness

Paediatric Early versus late PArenteral Nutrition In Critical illness - PEPaNIC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57759

Enrollment

720

Registered

2012-05-29

Start date

2012-09-12

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive care populatie catabolism malnutrition

Interventions

Early PN*, this nutritional regime is the standard therapy and therefor accounts as the "control-group". In the Leuven PICU, patients randomised to the *early PN* group upon admission to PICU receiv

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children 0 - 18 yrs expected stay in PICU > 24 hrs No oral nutrition

Exclusion criteria

Exclusion criteria: "do not resuscitate" or expected death 7 days TPN > 7 days prior to study congenital metabolic disorders

Design outcomes

Primary

Measure	Time frame
We will compare early PN with late PN in paediatric ICU patients at risk of developing malnutrition in the ICU. The primary focus of the PEPaNIC study is clinical outcome, more specifically the acquisition of new ICU infections, the dependency on intensive medical care and convalescence from critical illness. The primary efficacy endpoints for this RCT are the incidence of new infections and the time to discharge alive from ICU. Number of patients with new infections and types of infection will be assessed by numbers and percentages, and the duration of any antibiotics therapy initiated after randomisation for those patients requiring antibiotics will be analysed by non-parametrical tests. As the time of ICU discharge to the regular ward may be affected by the availability of beds on the regular wards, which could induce bias, we a priori decided to analyse time to discharge from ICU as time to ready for discharge from ICU. A patient is considered ready for discharge as soon as all clinical conditions for ICU discharge have been fulfilled (no longer in need for vital organ support). Time to discharge alive from ICU will be reported by Kaplan-Meier plots, with ICU non-survivors censored beyond the longest ICU stay of survivors and censoring time of patients still in the ICU at closing of the data file (90 days after last patient inclusion) over both treatment groups. The impact of late PN versus early PN will be analysed, with and without correction for age, nutritional status and risk categories and type and severity of illness, by Cox proportional hazard analysis. The distribution of the actual time to discharge from ICU will be reported for ICU-survivors and ICU-non-survivors separately. In view of the time window of the randomised intervention in ICU, also the proportion of patients staying beyond 8 days in ICU will be reported. Analyses on blood and urine for the primary clinical analyses include routine chemistry, haema	—

Measure

Time frame

We will compare *early PN* with *late PN* in paediatric ICU patients at risk of developing malnutrition in the ICU. The primary focus of the PEPaNIC study is clinical outcome, more specifically the acquisition of new ICU infections, the dependency on intensive medical care and convalescence from critical illness. The primary efficacy endpoints for this RCT are the incidence of new infections and the time to discharge alive from ICU. Number of patients with new infections and types of infection will be assessed by numbers and percentages, and the duration of any antibiotics therapy initiated after randomisation for those patients requiring antibiotics will be analysed by non-parametrical tests. As the time of ICU discharge to the regular ward may be affected by the availability of beds on the regular wards, which could induce bias, we a priori decided to analyse *time to discharge from ICU* as *time to ready for discharge from ICU*. A patient is considered *ready for discharge* as soon as all clinical conditions for ICU discharge have been fulfilled (no longer in need for vital organ support). Time to discharge alive from ICU will be reported by Kaplan-Meier plots, with ICU non-survivors censored beyond the longest ICU stay of survivors and censoring time of patients still in the ICU at closing of the data file (90 days after last patient inclusion) over both treatment groups. The impact of *late PN* versus *early PN* will be analysed, with and without correction for age, nutritional status and risk categories and type and severity of illness, by Cox proportional hazard analysis. The distribution of the actual time to discharge from ICU will be reported for ICU-survivors and ICU-non-survivors separately. In view of the time window of the randomised intervention in ICU, also the proportion of patients staying beyond 8 days in ICU will be reported. Analyses on blood and urine for the primary clinical analyses include routine chemistry, haema

—

Secondary

Measure	Time frame
All analyses will be performed uncorrected as well as corrected for age, nutritional status and risk categories and type and severity of illness. Time-to-event analysis will be analysed similarly as the primary endpoint. Proportion of patients requiring support of vital organ functions and distribution of duration of support will be analysed by non-parametric or parametric testing depending on the normality of the distribution in the subgroup of patients for which support was needed. Proportions will be compared using chi-square testing. Results of repeated measurements will be analysed using an appropriate model for longitudinal data. a. Time to final (alive) weaning from mechanical respiratory support: patients still on mechanical respiratory support at closing of the data file (90 days after last patient inclusion) will be censored at that time point. ICU non-survivors will be censored beyond the longest duration of mechanical respiratory support of the survivors. b. Kidney failure: Proportion of patients in need for renal replacement therapy (RRT) during ICU stay; distribution of duration of RRT (for those patients requiring RRT); proportion of patients with a post-randomisation diagnosis of new kidney injury/failure (defined by modified Risk, Injury, Failure, Loss, and End-stage Kidney (RIFLE) classification criteria as a plasma creatinine doubling or more during ICU stay) in both treatment groups. In addition, the duration of a score RIFLE>=2 will be used as a marker of time to recovery of kidney damage. c. Need for pharmacological or mechanical haemodynamic support during ICU stay, and duration of such need. In addition, time to final (alive) weaning from all pharmacological or mechanical haemodynamic support in ICU will be analysed, with ICU non-survivors censored beyond the longest duration of pharmacological or mechanical haemodynamic support of the survivors and censoring time of patients still on such support at closing of the	—

Measure

Time frame

All analyses will be performed uncorrected as well as corrected for age, nutritional status and risk categories and type and severity of illness. Time-to-event analysis will be analysed similarly as the primary endpoint. Proportion of patients requiring support of vital organ functions and distribution of duration of support will be analysed by non-parametric or parametric testing depending on the normality of the distribution in the subgroup of patients for which support was needed. Proportions will be compared using chi-square testing. Results of repeated measurements will be analysed using an appropriate model for longitudinal data. a. Time to final (alive) weaning from mechanical respiratory support: patients still on mechanical respiratory support at closing of the data file (90 days after last patient inclusion) will be censored at that time point. ICU non-survivors will be censored beyond the longest duration of mechanical respiratory support of the survivors. b. Kidney failure: Proportion of patients in need for renal replacement therapy (RRT) during ICU stay; distribution of duration of RRT (for those patients requiring RRT); proportion of patients with a post-randomisation diagnosis of new kidney injury/failure (defined by modified Risk, Injury, Failure, Loss, and End-stage Kidney (RIFLE) classification criteria as a plasma creatinine doubling or more during ICU stay) in both treatment groups. In addition, the duration of a score RIFLE>=2 will be used as a marker of time to recovery of kidney damage. c. Need for pharmacological or mechanical haemodynamic support during ICU stay, and duration of such need. In addition, time to final (alive) weaning from all pharmacological or mechanical haemodynamic support in ICU will be analysed, with ICU non-survivors censored beyond the longest duration of pharmacological or mechanical haemodynamic support of the survivors and censoring time of patients still on such support at closing of the

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)