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

This study has been completed.
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
HEIDEGGER CP, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00802503
First received: December 3, 2008
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention Phase
Critically Ill
Dietary Supplement: SPN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Documented Infection Rate [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28


Secondary Outcome Measures:
  • Hours on Mechanical Ventilation in All Patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mechanical ventilation hours during study duration (days 1-28)

  • Antibiotic Free Days [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Number of days between day 9 to day 28 (follow-up period) free of antibiotics

  • Total Energy Intake During the Intervention Period , Between Day 4 and Day 8. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.

  • General Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Days in ICU [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Days in ICU

  • ICU Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Protein Delivery During the Intervention Period From Day 4 to Day 8 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.

  • Days in Hospital [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    hospital length of stay


Enrollment: 305
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPN group

experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.

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. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

Dietary Supplement: SPN
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.
No Intervention: Control gr
EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.

Detailed Description:

Introduction:

Nutritional support of the intensive care (ICU) patients is recommended as a standard of care. It is also strongly recommended to start enteral feeding as soon as possible whenever the gastrointestinal tract is functioning (1). However, studies have repeatedly shown that with enteral support alone, insufficient energy and protein intakes often occur (2). The resulting energy and protein deficit is associated with an increased complication rate in ICU patients (3-5). Recently we proposed to decrease this deficit by promoting a combined nutrition support by enteral nutrition (EN) and supplemental parenteral nutrition (SPN) whenever EN is insufficient (6).

Contrary to former beliefs, recent meta-analyses show that parenteral nutrition (PN) does not carry excess mortality (7, 8). These reports convey a concept that is a major break-through in current routine of nutritional support in ICU patients by promoting a much wider use of PN. SPN could be the optimal modality to provide the calculated energy targets if this cannot be reached by EN alone. To improve ICU patient's outcome and minimise complications, we propose to implement feeding protocols which combine both EN and PN, when EN is insufficient to cover more than 60% of caloric needs at day 4 to reach 100% of the energy targets by adding PN from day 4 (6).

Hypothesis:

The administration of SPN, in ICU patients receiving < 60% of targeted energy needs by EN alone, has a positive impact on their clinical outcome by optimising their nutritional support (reduced infectious complications rate, mechanical ventilation days, duration of ICU and hospital length of stay and rehabilitation).

Objective:

The aim of the present study is to investigate if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients achieved with the combined administration of SPN and EN optimizes their clinical outcome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802503

Locations
Switzerland
Service of Intensive Care, Geneva University Hospital,
Geneva, Switzerland, 1211
Service de Médecine Intensive Adulte et Centre des Brûlés
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
Investigators
Principal Investigator: Claudia P HEIDEGGER, MD Division of Intensive Care, 1211 Geneva 14, Switzerland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HEIDEGGER CP, Deputy head physician, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00802503     History of Changes
Other Study ID Numbers: Protocole 07-098
Study First Received: December 3, 2008
Results First Received: January 7, 2013
Last Updated: April 18, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Critically ill
nutrition
randomised controlled clinical trial
human
adult
Supplemental parenteral nutrition

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014