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


  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 ]

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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Dr CP Heidegger
Organization: Geneva University Hospitals, Division of Intensive Care,Rue Gabrielle Perret Gentil 4, CH-1211 Geneva 14/Switzerland
phone: +41223827440
e-mail: claudia-paula.heidegger@hcuge.ch


Publications:
Publications automatically indexed to this study:

Responsible Party: HEIDEGGER CP, 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