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
  Hide Baseline Characteristics

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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Documented Infection Rate
Measure Description Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28
Time Frame 20 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.
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 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  
Documented Infection Rate  
[units: Infections]
  58     41  

No statistical analysis provided for Documented Infection Rate



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

Measure Type Secondary
Measure Title Hours on Mechanical Ventilation in All Patients
Measure Description Mechanical ventilation hours during study duration (days 1-28)
Time Frame 28 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  
Hours on Mechanical Ventilation in All Patients  
[units: hours of mechanical ventilation]
Mean ( 95% Confidence Interval )
  166  
  ( 138 to 189 )  
  153  
  ( 126 to 178 )  

No statistical analysis provided for Hours on Mechanical Ventilation in All Patients



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

Measure Type Secondary
Measure Title Antibiotic Free Days
Measure Description Number of days between day 9 to day 28 (follow-up period) free of antibiotics
Time Frame 20 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  
Antibiotic Free Days  
[units: number of days]
Mean ( 95% Confidence Interval )
  12  
  ( 10 to 13 )  
  14  
  ( 12 to 15 )  

No statistical analysis provided for Antibiotic Free Days



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

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 ]

Measure Type Secondary
Measure Title General Mortality
Measure Description No text entered.
Time Frame 28 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 Group 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 Group     SPN Group  
Number of Participants Analyzed  
[units: participants]
  152     153  
General Mortality  
[units: participants]
  28     20  

No statistical analysis provided for General Mortality



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

Measure Type Secondary
Measure Title Days in ICU
Measure Description Days in ICU
Time Frame 28 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  
Days in ICU  
[units: days in ICU]
Mean ( 95% Confidence Interval )
  13  
  ( 12 to 14 )  
  13  
  ( 11 to 14 )  

No statistical analysis provided for Days in ICU



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

Measure Type Secondary
Measure Title ICU Mortality
Measure Description No text entered.
Time Frame 28 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  
ICU Mortality  
[units: participants]
  12     8  

No statistical analysis provided for ICU Mortality



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

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 ]

Measure Type Secondary
Measure Title Days in Hospital
Measure Description hospital length of stay
Time Frame 28 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 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.


Measured Values
    Control gr     SPN Group  
Number of Participants Analyzed  
[units: participants]
  152     153  
Days in Hospital  
[units: days in hospital]
Mean ( 95% Confidence Interval )
  32  
  ( 29 to 39 )  
  31  
  ( 29 to 38 )  

No statistical analysis provided for Days in Hospital




  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