NCT00522730

Brief Summary

The purpose of the study is to determine the tolerance on lipid metabolism and the safety of short-term parenteral nutrition as compared to enteral nutrition in critically ill patients with liver failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

August 29, 2007

Last Update Submit

September 2, 2009

Conditions

Liver FailureCritical Illness

Keywords

Liver failureLiver cirrhosisParenteral nutritionEnteral nutritionLipidsSafetyDrug tolerance

Outcome Measures

Primary Outcomes (1)

  • Change in plasma concentration of triglycerides, total cholesterol, HDL-cholesterol, free fatty acids, apolipoproteins, lipoprotein (a)

    within 5 days

Secondary Outcomes (8)

  • Incidence of hyperglycaemia

    within 5 days

  • Alteration of liver function

    within 5 and 28 days

  • Gastrointestinal intolerance

    within 5 days

  • Gastrointestinal bleeding

    within 5 and 28 days

  • Septic complications

    within 5 and 28 days

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Parenteral nutrition

Other: Parenteral nutrition

2

ACTIVE COMPARATOR

Enteral nutrition

Other: Enteral nutrition

Interventions

Parenteral nutritionOTHER

Duration : 5 days

1
Enteral nutritionOTHER

Duration : 5 days

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consecutive patients with a diagnosis of chronic liver failure;
  • Planned total nutritional support;
  • Adult patient aged 18 years or above, and less than 85;
  • Admission to the ICU for an expected period of \> 24 hours;
  • Informed consent of the patient or nearest relative.

You may not qualify if:

  • Absolute contra-indications to enteral nutrition : total mechanical ileus, persistent vomiting, high output fistulas, uncertain gastrointestinal anastomosis;
  • Absolute contra-indications to parenteral nutrition : severe hypertriglyceridemia \> 6 mmol/l (\> 545 mg/dL), severe diabetic ketoacidosis;
  • Age less than 18 years or more than 85;
  • Pregnancy, including HELLP syndrome;
  • Acquired immunodeficiency syndrome and antiretroviral therapy;
  • Refusal of the patient or nearest relative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of intensive care, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Liver FailureCritical IllnessLiver CirrhosisHyperphagia

Interventions

Parenteral NutritionEnteral Nutrition

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosisSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Pierre-François Laterre, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

  • Yvan Fleury, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

BE(1)