Trial Outcomes & Findings for Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients (NCT NCT00802503)

Results Overview

Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

305 participants

Primary outcome timeframe

20 days

Results posted on

2013-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	152	153
Overall Study COMPLETED	142	133
Overall Study NOT COMPLETED	10	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control gr n=152 Participants 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 n=153 Participants 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 n=305 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	83 Participants n=7 Participants	174 Participants n=5 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants	70 Participants n=7 Participants	131 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 16 • n=5 Participants	61 years STANDARD_DEVIATION 16 • n=7 Participants	60 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	110 Participants n=7 Participants	215 Participants n=5 Participants
Region of Enrollment Switzerland	152 participants n=5 Participants	153 participants n=7 Participants	305 participants n=5 Participants

PRIMARY outcome

Timeframe: 20 days

Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28