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
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Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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:
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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. |
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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 |
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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. |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
305 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 |
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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 |