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Sponsors and Collaborators: |
Katholieke Universiteit Leuven Fund for Scientific Research, Flanders, Belgium Baxter Healthcare Corporation |
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Information provided by: | Katholieke Universiteit Leuven |
ClinicalTrials.gov Identifier: | NCT00512122 |
In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.
Condition | Intervention | Phase |
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Critical Illness Starvation |
Other: Withholding PN during the first week of ICU stay Drug: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients |
Estimated Enrollment: | 4640 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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EN only: Experimental |
Other: Withholding PN during the first week of ICU stay
Patients in this arm will receive exclusively enteral nutrition. If enteral nutrition is insufficient after the seventh day of ICU stay, parenteral nutrition will be started.
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EN plus early PN: Active Comparator |
Drug: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E
PN will be started the morning of the third ICU hospitalisation day. The amount of PN to be given will be calculated to cover the caloric needs of the patient, based on the enteral energy intake the previous 24 hours.
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Written informed consent will be obtained from the patient or the closest family member or legal guardian. The family member or the patient can withdraw from the trial, at any time, without impact on his treatment or penalty. The investigators confirm that this study concerns a condition that directly threatens patient health and that the adult patient not able to give consent suffers from the condition. The experiment is essential to confirm the results from earlier research in patients who could consent or from other research methods.
On admission patients will be randomly assigned to receive EN combined with early PN or only EN. At ICU admission, consecutive patients will be randomly assigned to one of these two treatment groups using blinded envelopes, stratified according to primary diagnostic category on admission.
As initial nutritional support, patients randomised to the 'EN combined with early PN' group will receive glucose 20% at 40 ml/hr. EN will be initiated in the evening of the second ICU hospitalisation day, PN will be started the morning of the third ICU hospitalisation day. The amount of PN to be given on any particular day will be the difference between calculated caloric needs and the calories delivered by EN the previous 24 hours. When EN covers 80% of calculated caloric needs PN will be stopped. When the patient is able to eat, the parenteral regimen will be reduced and eventually stopped. Whenever oral (+ enteral) intake is below 50% of calculated caloric needs, the PN will be (re)-started.
As initial nutritional support, patients randomised to the 'EN only' group will receive glucose 5% at 40 ml/hr. EN will be initiated on the evening of the second ICU day. From the morning of the third ICU hospitalisation day on, the amount of glucose 5% to be given will be the same as the volume of PN the patient theoretically would require to receive 100% of presumed caloric needs based on the amount of EN delivered the previous 24 hours. When the patient is able to eat, the parenteral regimen (glucose 5%) will be reduced to 50% and eventually stopped. Whenever oral (+ enteral) intake is below 50% of calculated caloric needs, the PN (glucose 5%) will be (re)-started. If these patients would need to stay for more than seven days on the ICU and enteral feeding of at least 80% of the calculated calories is not possible, they will be switched to EN and PN on day eight.
Common strategy for attempting early enteral nutrition in both study arms:
EN will be initiated on the evening of the second ICU day, unless patients are able to eat. The increase of enteral feeding volume and the adaptation of the regimen to pathological conditions will be according to protocol. Trace elements, minerals and vitamins will be administered daily intravenously (IV) to all patients from the day of admission onwards. IV substitution will be stopped in patients receiving at least 1500 ml of EN. All patients will be treated following the intensive insulin therapy schedule - targeting a blood glucose level of 80 - 110 mg/dl - from admission until discharge or oral feeding.
Patients will be weaned from the ventilator according to a standard protocol. End-of-care decisions in patients for whom further intensive care is considered to be futile will be taken in consensus by a group of two senior ICU physicians and the referring specialist, all blinded to study treatment allocation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michaël P Casaer, MD | 32-16-344-017 ext - | michael.casaer@uz.kuleuven.ac.be |
Contact: Greet Van den Berghe, MD Ph D | 32-16-344-017 ext - | greet .vandenberghe@med.kuleuven.be |
Belgium | |
Surgical Intensive Care Unit, Catholic University Leuven University Hospitals | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Michael P. Casaer, MD 32-16-344-017 ext - michael.casaer@uz.kuleuven.ac.be | |
Contact: Greet - Van den Berghe, MD Ph D 32-16-344-017 ext - greet.vandenberghe@med.kuleuven.be | |
Principal Investigator: Michaël Casaer, MD | |
Principal Investigator: Greet Van den Berghe, MD, Ph D | |
Medical Intensive Care Unit | Not yet recruiting |
Leuven, Belgium, 3000 | |
Contact: Alexander P. Wilmer, MD Ph D 32-16-348-719 ext - alexander.wilmer@med.kuleuven.be | |
Contact: Michaël P. Casaer, MD 32-16-344-017 ext - michael.casaer@uz.kuleuven.ac.be | |
Principal Investigator: Alexander P. Wilmer, MD, Ph D | |
Principal Investigator: Greet Van den Berghe, MD, Ph D |
Study Director: | Greet Van den Berghe, MD Ph D | Director of the Department of Intensive Care Medicine Catholic Univeresity Leuven |
Principal Investigator: | Michaël P Casaer, MD | Department of Intensive Care Medicine Catholic University Leuven |
Principal Investigator: | Alexander P Wilmer, MD Ph D | Department of Medicine Catholic University Leuven |
Responsible Party: | Director of the Department of Intensive Care Medicine Catholic University Leuven ( Greet Van den Berghe MD PhD ) |
Study ID Numbers: | EPaNIC 2007 1-1-7, ISRCTN 76223876, EudraCT 2007-000169-40, S 50404 |
Study First Received: | July 31, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00512122 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
early parenteral nutrition critical illness respiratory failure kidney failure hepatic failure |
muscle strength rehabilitation overfeeding Reduced Oral Intake |
Starvation Liver Failure Malnutrition |
Critical Illness Nutrition Disorders Kidney Failure |
Disease Attributes Pathologic Processes |