Phase 3
N=305
Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
Critically Ill
Bottom Line
View on ClinicalTrials.gov: NCT00802503 ↗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
| Outcome | Result | p-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
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.