CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
SPNdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00802503
NCT00802503Phase 3Completed

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

University Hospital, Geneva·interventional·Posted Dec 5, 2008·Updated Apr 19, 2013

In Brief

A Phase 3 clinical trial evaluating SPN for Critically Ill. Completed, enrolled 305 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill
CountriesSwitzerland

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.6 years ago

Interventions

SPNdietary

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.