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Phase 3 N=305 Randomized Supportive Care

Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients

Critically Ill

Enrolled (actual)
305
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Documented Infection Rate — 58; 41 Infections

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
SPN (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospital, Geneva
Primary completion
Jul 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Documented Infection Rate
58; 41
SECONDARY
Hours on Mechanical Ventilation in All Patients
166; 153
SECONDARY
Antibiotic Free Days
12; 14
SECONDARY
Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.
77; 103
SECONDARY
General Mortality
28; 20
SECONDARY
Days in ICU
13; 13
SECONDARY
ICU Mortality
12; 8
SECONDARY
Protein Delivery During the Intervention Period From Day 4 to Day 8
71; 100
SECONDARY
Days in Hospital
32; 31

Summary

Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient ( 5 days, expected survival > 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen. Exclusion criteria: refusal of consent, age 1,5 liter/d), patients receiving PN. Nutrition: At day 3 after admission, if energy input is < 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration. Study endpoints: * Primary: nosocomial infections (CDC criteria) * Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.

Eligibility Criteria

Inclusion Criteria

  • Expected ICU stay > 5 days
  • Expected survival > 7 days
  • No contraindication to EN
  • Obtained informed consent

Exclusion Criteria

  • Refusal of consent
  • Age 1.5 liter/d)
  • Patients receiving PN
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00802503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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