Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
Condition: Critically Ill
MeSH terms: Critical Illness
Intervention: SPN
Intervention description: SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Critically ill; nutrition; randomised controlled clinical trial; human; adult; Supplemental parenteral nutrition

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 (< 60%
      of their predicted energy needs) at day 3 after admission in the ICU.

      Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support
      (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and
      EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.

      Study design: Prospective, controlled, randomized clinical study.

      Study site: Service of Intensive Care, Geneva University Hospital.

      Patient population: 220 ICU patients to be included: expected length of stay > 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 < 18 years, short bowel syndrome, significant
      persistent gastrointestinal dysfunction with ileus, high output proximal fistula (> 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 < 18 years

          -  Short bowel syndrome

          -  Significant persistent gastrointestinal dysfunction with ileus

          -  High output proximal fistula (> 1.5 liter/d)

          -  Patients receiving PN