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
Results First Received: January 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Critically Ill
Intervention: Dietary Supplement: SPN

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group 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.
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.

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.


Participant Flow:   Overall Study
    Control Group     SPN Group  
STARTED     152     153  
COMPLETED     142     133  
NOT COMPLETED     10     20  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Documented Infection Rate   [ Time Frame: 20 days ]

2.  Secondary:   Hours on Mechanical Ventilation in All Patients   [ Time Frame: 28 days ]

3.  Secondary:   Antibiotic Free Days   [ Time Frame: 20 days ]

4.  Secondary:   Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.   [ Time Frame: 5 days ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.
Measure Description 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.
Time Frame 5 days  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).

Reporting Groups
  Description
Control gr EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
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.

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.


Measured Values
    Control gr     SPN Group  
Number of Participants Analyzed  
[units: participants]
  152     153  
Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.  
[units: % of energy target]
Mean ± Standard Deviation
  77  ± 27     103  ± 18  

No statistical analysis provided for Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.



5.  Secondary:   General Mortality   [ Time Frame: 28 days ]

6.  Secondary:   Days in ICU   [ Time Frame: 28 days ]

7.  Secondary:   ICU Mortality   [ Time Frame: 28 days ]

8.  Secondary:   Protein Delivery During the Intervention Period From Day 4 to Day 8   [ Time Frame: 5 days ]

9.  Secondary:   Days in Hospital   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was limited by the fact that it was not double blinded by design. However, the risk of bias was reduced because the investigators worked independently from the physicians in charge of the patients.


  More Information