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

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ClinicalTrials.gov Identifier: NCT00802503
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
HEIDEGGER CP, University Hospital, Geneva

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
Enrollment 305
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group SPN Group
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 152 153
Completed 142 133
Not Completed 10 20
Arm/Group Title Control gr SPN Group Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 152 153 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 153 participants 305 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
  59.9%
83
  54.2%
174
  57.0%
>=65 years
61
  40.1%
70
  45.8%
131
  43.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 153 participants 305 participants
60  (16) 61  (16) 60  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 153 participants 305 participants
Female
47
  30.9%
43
  28.1%
90
  29.5%
Male
105
  69.1%
110
  71.9%
215
  70.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 152 participants 153 participants 305 participants
152 153 305
1.Primary Outcome
Title Documented Infection Rate
Hide Description Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28
Time Frame 20 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: Infections
58 41
2.Secondary Outcome
Title Hours on Mechanical Ventilation in All Patients
Hide Description Mechanical ventilation hours during study duration (days 1-28)
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (95% Confidence Interval)
Unit of Measure: hours of mechanical ventilation
166
(138 to 189)
153
(126 to 178)
3.Secondary Outcome
Title Antibiotic Free Days
Hide Description Number of days between day 9 to day 28 (follow-up period) free of antibiotics
Time Frame 20 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (95% Confidence Interval)
Unit of Measure: number of days
12
(10 to 13)
14
(12 to 15)
4.Secondary Outcome
Title Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (Standard Deviation)
Unit of Measure: % of energy target
77  (27) 103  (18)
5.Secondary Outcome
Title General Mortality
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control Group SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: participants
28 20
6.Secondary Outcome
Title Days in ICU
Hide Description Days in ICU
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (95% Confidence Interval)
Unit of Measure: days in ICU
13
(12 to 14)
13
(11 to 14)
7.Secondary Outcome
Title ICU Mortality
Hide Description [Not Specified]
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: participants
12 8
8.Secondary Outcome
Title Protein Delivery During the Intervention Period From Day 4 to Day 8
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Controle gr SPN gr
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (Standard Deviation)
Unit of Measure: percentage of protein target
71  (27) 100  (16)
9.Secondary Outcome
Title Days in Hospital
Hide Description hospital length of stay
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 152 153
Mean (95% Confidence Interval)
Unit of Measure: days in hospital
32
(29 to 39)
31
(29 to 38)
Time Frame The follow up period was until day 28.
Adverse Event Reporting Description No adverse events were observed during the intervention period from day 4 to day 8.
 
Arm/Group Title Control gr SPN Group
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Control gr SPN Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control gr SPN Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/152 (0.00%)   0/153 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control gr SPN Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/152 (0.00%)   0/153 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
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
Responsible Party: HEIDEGGER CP, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00802503     History of Changes
Other Study ID Numbers: Protocole 07-098
First Submitted: December 3, 2008
First Posted: December 5, 2008
Results First Submitted: January 7, 2013
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013