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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
History of Changes
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
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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.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Control gr     SPN Group     Total  
Number of Participants  
[units: participants]
 		  152     153     305  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     91     83     174  
>=65 years     61     70     131  
Age  
[units: years]
Mean (Standard Deviation) 		  60  (16)     61  (16)     60  (17)  
Gender  
[units: participants]
 		     
Female     47     43     90  
Male     105     110     215  
Region of Enrollment  
[units: participants]
 		     
Switzerland     152     153     305  



  Outcome Measures
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1.  Primary:   Documented Infection Rate   [ Time Frame: 20 days ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

Measure Type Secondary
Measure Title Protein Delivery During the Intervention Period From Day 4 to Day 8
Measure Description 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.
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
Controle 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 gr

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
    Controle gr     SPN gr  
Number of Participants Analyzed  
[units: participants]
 		  152     153  
Protein Delivery During the Intervention Period From Day 4 to Day 8  
[units: percentage of protein target]
Mean (Standard Deviation) 		  71  (27)     100  (16)  

No statistical analysis provided for Protein Delivery During the Intervention Period From Day 4 to Day 8



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


  Serious Adverse Events
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  Other Adverse Events
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  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
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