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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802503
First Posted: December 5, 2008
Last Update Posted: April 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
HEIDEGGER CP, University Hospital, Geneva
Results First Submitted: January 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Critically Ill
Intervention: Dietary Supplement: SPN

  Participant Flow


  Baseline Characteristics


  Outcome Measures
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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 ]

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