NCT00798681

Brief Summary

This is an international prospective randomized multicenter open-label controlled study. The primary center will be Fernandes Távora Hospital (Fortaleza, Ceará). The aim of this study is to investigate the effects of closed parenteral nutrition systems when compared to open parenteral nutrition systems in terms of several clinical outcomes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
3 countries

8 active sites

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

July 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 10, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

November 25, 2008

Last Update Submit

August 9, 2010

Conditions

Parenteral Nutrition

Keywords

parenteral nutritionready-to-usecustomized nutrition formulationolive oilsoybean oilLCT/MCTClinoleicoliclinomelnumber of infections associated with TPN delivery systemBSIInfection rates

Outcome Measures

Primary Outcomes (1)

  • Incidence of bloodstreams and catheter infection, as well as incidence of sepsis, severe sepsis and septic shock. Sepsis diagnostic criteria will be re-evaluated on a daily basis.

    28-day follow up

Secondary Outcomes (8)

  • 28-days all cause mortality

    28-days follow-up period

  • Time to start parenteral nutrition, defined as the time from prescription to the effective start of infusion

    Time from prescription to the effective start of TPN

  • Incidence of hyperglycemic events, defined as the number of times patients developed blood glucose levels over 110 mg/dL and over 150 mg/dL

    For the duration of TPN

  • Incidence of hypoglycemic events: defined as the number of times patients developed blood glucose levels bellow 60 mg/dL

    For the duration of TPN

  • Mean dose of insulin used (patients will receive insulin in order to maintain blood glucose levels <150 mg/dL (or 8.3 mmol/L) in accordance with the Surviving Sepsis Campaign Guidelines)

    For the duration of TPN

  • +3 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Patients will receive RTU TPN with olive-oil as the primary source of lipids

Dietary Supplement: RTU TPN with olive oil as the primary lipid source

2

ACTIVE COMPARATOR

CNF parenteral nutrition made with olive oil as the primary source of lipids

Other: CNF Parenteral nutrition

3

ACTIVE COMPARATOR

CNF parenteral nutrition made with LCT/MCT as the primary source of lipids

Other: CNF parenteral nutrition

Interventions

RTU TPN with olive oil as the primary lipid sourceDIETARY_SUPPLEMENT

RTU will be provided as a 3 in 1 TPN ready-to-use TPN system in industrialized bags with 2.000 ml. The number of calories will be adjusted in accordance with patients' individual needs.

Also known as: OliClinomel, Baxter Healthcare
1
CNF parenteral nutritionOTHER

CNF parenteral nutrition made with olive oil as the primary source of lipids

Also known as: ClinOleic, Baxter Healthcare
2

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 years of age with recommendation to use total parenteral nutrition.
  • Caloric goals will be calculated using BEE adjusted by the pathology of the patient. In addition, patients MUST achieve at least once 75% of BEE (calculated using the Harris-Benedict equation) to be considered evaluable. Caloric intake will be accessed in a daily basis.
  • This study will be performed in accordance with all ethics statements of the Helsinki's Declaration (52nd General Assembly of the World Medical Association, Edinburgh, Scotland, October, 2000), and of the Nuremberg Code.
  • In addition, this study must be approved by the Institutional Review Board before patient enrollment and by the Federal Council of Research and Ethics of the Ministry of Health.
  • All participating institutions will also be requested to observe Good Clinical Practice Guidelines and all federal laws and regulations.
  • An informed consent will be obtained from all patients or their legal representatives before any study related procedure.

You may not qualify if:

  • Pregnancy or breastfeeding
  • Patients under 18 years of age
  • Significant limitation of survival prognosis (patients expecting a life survival under 28 days due to a chronic and/or incurable disease such as uncontrolled cancer or other terminal disease)
  • Head trauma with a Glasgow Come Score (GCS) less or equal to 5
  • Severe immunologic suppression (defined as a leukocyte count bellow 5.000 cells/mm3)
  • Infection by the human immunodeficiency virus
  • Patients with no indication for parenteral feeding or in the imminence of receiving enteral nutrition
  • Patients receiving partial parenteral nutrition in order to achieve caloric goal, or patient's, patient's legal representative or physicians decision to exclude patients from this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sanatorio Los Arcos

Buenos Aires, Argentina

Location

Sanatorio Trinidad Palermo

Buenos Aires, Argentina

Location

Fernandes Tavora Hospital

Fortaleza, Ceará, 60.115-000, Brazil

Location

Hospital Santa Luzia

Brasília, Federal District, 70390-010, Brazil

Location

Hospital da Polícia Militar

Rio de Janeiro, Rio de Janeiro, 22271-110, Brazil

Location

Hospital Samaritano

Rio de Janeiro, Rio de Janeiro, 22271-110, Brazil

Location

Hospital Bandeirantes

São Paulo, São Paulo, 01506-000, Brazil

Location

Hospital Roosevelt

Guatemala City, Guatemala

Location

Related Publications (1)

  • Pontes-Arruda A, Dos Santos MC, Martins LF, Gonzalez ER, Kliger RG, Maia M, Magnan GB; EPICOS Study Group. Influence of parenteral nutrition delivery system on the development of bloodstream infections in critically ill patients: an international, multicenter, prospective, open-label, controlled study--EPICOS study. JPEN J Parenter Enteral Nutr. 2012 Sep;36(5):574-86. doi: 10.1177/0148607111427040. Epub 2012 Jan 23.

    PMID: 22269899DERIVED

MeSH Terms

Conditions

Hyperphagia

Interventions

Olive OilClinOleic

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Alessandro Pontes-Arruda, MD, MSc, PhD, FCCM

    Fernandes Tavora Hospital

    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

November 25, 2008

First Posted

November 26, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-07

Locations

AR(2)BR(5)GU(1)