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

Tracking Information
First Submitted Date ICMJE	December 3, 2008
First Posted Date ICMJE	December 5, 2008
Results First Submitted Date	January 7, 2013
Results First Posted Date	April 19, 2013
Last Update Posted Date	April 19, 2013
Study Start Date ICMJE	May 2008
Actual Primary Completion Date	July 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 18, 2013)	Documented Infection Rate [ Time Frame: 20 days ]; Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28
Original Primary Outcome Measures ICMJE; (submitted: December 4, 2008)	Documented infection rate defined according to CDC criteria during the ICU and hospital stay [ Time Frame: 3 months ]
Change History	Complete list of historical versions of study NCT00802503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 18, 2013)	Hours on Mechanical Ventilation in All Patients [ Time Frame: 28 days ]Mechanical ventilation hours during study duration (days 1-28); Antibiotic Free Days [ Time Frame: 20 days ]Number of days between day 9 to day 28 (follow-up period) free of antibiotics; Total Energy Intake During the Intervention Period , Between Day 4 and Day 8. [ Time Frame: 5 days ]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.; General Mortality [ Time Frame: 28 days ]; Days in ICU [ Time Frame: 28 days ]Days in ICU; ICU Mortality [ Time Frame: 28 days ]; Protein Delivery During the Intervention Period From Day 4 to Day 8 [ Time Frame: 5 days ]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.; Days in Hospital [ Time Frame: 28 days ]hospital length of stay
Original Secondary Outcome Measures ICMJE; (submitted: December 4, 2008)	Mechanical ventilation, Antibiotic free days, Decreased ICU and hospital los, ICU complications, Energy and protein balance , 28 and 60 D outcome & qol at 3 months after hospital discharge [ Time Frame: 3 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
Official Title ICMJE	Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines
Brief Summary	Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (< 60% of their predicted energy needs) at day 3 after admission in the ICU. Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines. Study design: Prospective, controlled, randomized clinical study. Study site: Service of Intensive Care, Geneva University Hospital. Patient population: 220 ICU patients to be included: expected length of stay > 5 days, expected survival > 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen. Exclusion criteria: refusal of consent, age < 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (> 1,5 liter/d), patients receiving PN. Nutrition: At day 3 after admission, if energy input is < 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration. Study endpoints: Primary: nosocomial infections (CDC criteria); Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.
Detailed Description	Introduction: Nutritional support of the intensive care (ICU) patients is recommended as a standard of care. It is also strongly recommended to start enteral feeding as soon as possible whenever the gastrointestinal tract is functioning (1). However, studies have repeatedly shown that with enteral support alone, insufficient energy and protein intakes often occur (2). The resulting energy and protein deficit is associated with an increased complication rate in ICU patients (3-5). Recently we proposed to decrease this deficit by promoting a combined nutrition support by enteral nutrition (EN) and supplemental parenteral nutrition (SPN) whenever EN is insufficient (6). Contrary to former beliefs, recent meta-analyses show that parenteral nutrition (PN) does not carry excess mortality (7, 8). These reports convey a concept that is a major break-through in current routine of nutritional support in ICU patients by promoting a much wider use of PN. SPN could be the optimal modality to provide the calculated energy targets if this cannot be reached by EN alone. To improve ICU patient's outcome and minimise complications, we propose to implement feeding protocols which combine both EN and PN, when EN is insufficient to cover more than 60% of caloric needs at day 4 to reach 100% of the energy targets by adding PN from day 4 (6). Hypothesis: The administration of SPN, in ICU patients receiving < 60% of targeted energy needs by EN alone, has a positive impact on their clinical outcome by optimising their nutritional support (reduced infectious complications rate, mechanical ventilation days, duration of ICU and hospital length of stay and rehabilitation). Objective: The aim of the present study is to investigate if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients achieved with the combined administration of SPN and EN optimizes their clinical outcome.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Critically Ill
Intervention ICMJE	Dietary Supplement: 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.
Study Arms	Experimental: 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. Intervention: Dietary Supplement: SPN; No Intervention: 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.
Publications *	Heidegger CP, Romand JA, Treggiari MM, Pichard C. Is it now time to promote mixed enteral and parenteral nutrition for the critically ill patient? Intensive Care Med. 2007 Jun;33(6):963-9. Epub 2007 Apr 28.; Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 8, 2011)	305
Original Estimated Enrollment ICMJE; (submitted: December 4, 2008)	220
Actual Study Completion Date	July 2011
Actual Primary Completion Date	July 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Expected ICU stay > 5 days; Expected survival > 7 days; No contraindication to EN; Obtained informed consent Exclusion Criteria: Refusal of consent; Age < 18 years; Short bowel syndrome; Significant persistent gastrointestinal dysfunction with ileus; High output proximal fistula (> 1.5 liter/d); Patients receiving PN
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Switzerland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00802503
Other Study ID Numbers ICMJE	Protocole 07-098
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	HEIDEGGER CP, University Hospital, Geneva
Study Sponsor ICMJE	University Hospital, Geneva
Collaborators ICMJE	University of Lausanne Hospitals
Investigators ICMJE	Principal Investigator: Claudia P HEIDEGGER, MD Division of Intensive Care, 1211 Geneva 14, Switzerland
PRS Account	University Hospital, Geneva
Verification Date	April 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP