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Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients (EPaNIC)
This study is currently recruiting participants.
Verified by Katholieke Universiteit Leuven, October 2008
Sponsors and Collaborators: Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Baxter Healthcare Corporation
Information provided by: Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00512122
  Purpose

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
Critical Illness
Starvation
Other: Withholding PN during the first week of ICU stay
Drug: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E
Phase IV

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
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

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Length of stay in ICU and the hospital [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death (hospital and ICU mortality) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Days to weaning from mechanical ventilation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The need for renal replacement therapies [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The presence or absence of new kidney injury during intensive care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Days of vasopressor or inotropic support [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The presence or absence of hyperbilirubinemia and liver steatosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The need for tracheotomy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The presence or absence of hyper-inflammation within five days after ICU admission [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Blood lipid profiles and albumin on days one, five, ten, and fifteen after admission [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The presence or absence of bacteraemia, ventilator-associated pneumonia and of wound infections [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Episodes of hypoglycaemic events (defined as glycemia less than 40 mg/dl) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Amount and type of calories delivered [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Muscle strength and rehabilitation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients admitted to any of the five intensive care units
  2. Older than 18 years
  3. Nutritional risk screening score (NRS) higher or equal to three upon ICU admission

Exclusion Criteria:

  1. Patients with a do not resuscitate (DNR) code or moribund at the time of ICU admission
  2. Patients already enrolled in another trial
  3. Patients transferred from another intensive care unit with an established nutritional therapy
  4. Patients suffering from ketoacidotic or hyperosmolar coma on admission
  5. Patients with a body mass index (BMI) below 17 kg/m^2
  6. Short bowel syndrome
  7. Patients known to be pregnant or nursing
  8. Patients on mechanical ventilation at home
  9. NRS score lower than three
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512122

Contacts
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

Locations
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            
Sponsors and Collaborators
Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Baxter Healthcare Corporation
Investigators
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
  More Information

Katholieke Universiteit Leuven Homepage  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by Katholieke Universiteit Leuven:
early parenteral nutrition
critical illness
respiratory failure
kidney failure
hepatic failure
muscle strength
rehabilitation
overfeeding
Reduced Oral Intake

Study placed in the following topic categories:
Starvation
Liver Failure
Malnutrition
Critical Illness
Nutrition Disorders
Kidney Failure

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009