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Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients

NCT00512122 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4640

Last updated 2024-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Critical Illness
  • Starvation

Interventions

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.

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.

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • KU Leuven

    lead OTHER

Principal Investigators

  • Greet Van den Berghe, MD Ph D · Director of the Department of Intensive Care Medicine Catholic Univeresity Leuven

  • Michaël P Casaer, MD · Department of Intensive Care Medicine Catholic University Leuven

  • Alexander P Wilmer, MD Ph D · Department of Medicine Catholic University Leuven

  • Jasperina Dubois, MD · Surgical Intensive Care Unit Regional Hospital Jessa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-02-28
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00512122 on ClinicalTrials.gov