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Parenteral NutritionPhase 4EPICOSNCT00798681

Evaluating the Influence of Ready-to-use (RTU) Parenteral Nutrition in the Clinical Outcome of Patients Study

A Phase 4 study testing RTU TPN with olive oil as the primary lipid source and CNF Parenteral nutrition in people with Parenteral Nutrition, run by Fernandes Tavora Hospital at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parenteral Nutrition
What is being tested?
RTU TPN with olive oil as the primary lipid source and CNF Parenteral nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
8 sitesin 3 countries
Study dates
Jul 2008to Jul 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
  • Pre-existing chronic renal insufficiency and need of hemodialysis or peritoneal dialysis, participation in other clinical trial less than 3 months before inclusion in this trial
  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Brazil5 sites

  • Hospital Santa Luzia

    Brasília, Federal District, 70390-010

  • Fernandes Tavora Hospital

    Fortaleza, Ceará, 60.115-000

  • Hospital da Polícia Militar

    Rio de Janeiro, Rio de Janeiro, 22271-110

  • Hospital Samaritano

    Rio de Janeiro, Rio de Janeiro, 22271-110

  • Hospital Bandeirantes

    São Paulo, São Paulo, 01506-000

Other trials in Brazil

Argentina2 sites

  • Sanatorio Los Arcos

    Buenos Aires

  • Sanatorio Trinidad Palermo

    Buenos Aires

Other trials in Argentina

Guatemala1 site

  • Hospital Roosevelt

    Guatemala City

Other trials in Guatemala

About this study

Official title: EPICOS- Evaluating the Influence of RTU Parenteral Nutrition in the Clinical Outcome Patients Study

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.

Read the detailed description

In most Latin-American countries individually customized nutrition formulations (CNF) remains the gold-standard for parenteral nutrition in opposition to industrialized ready-to-use parenteral nutrition (RTU). Although CNF is possibly associated with elevated infection rates, delay in the start of enteral nutrition and worse clinical outcomes there is no strong scientific evidence in the literature to support that the use of RTU is indeed associated with better clinical outcomes.

The use of closed ready-to-use parenteral nutrition systems is probably associated with less infection rates and better clinical outcomes including less time at the hospital and at the intensive care unit, less consumption of hospital resources and most likely lower mortality rates as well as early initiation of parenteral nutrition support. The aim of this study is to evaluate all the above mentioned parameters in contrast with those observed when using CNF parenteral nutrition.

Being tested
RTU TPN with olive oil as the primary lipid source, CNF Parenteral nutrition
Keywords
parenteral nutrition, ready-to-use, customized nutrition formulation, olive oil, soybean oil, LCT/MCT, Clinoleic, oliclinomel, number of infections associated with TPN delivery system, BSI, Infection rates
Medical subject headings
Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTU TPN with olive oil as the primary lipid sourceDietary supplement

    Also called OliClinomel, Baxter Healthcare

    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.

  • CNF Parenteral nutritionOther

    Also called ClinOleic, Baxter Healthcare

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

  • CNF parenteral nutritionOther

    Also called LCT/MCT providers may vary

    3 in 1 CNF parenteral nutrition made with LCT/MCT as the primary source of lipids

Study groups in NCT00798681
Study groupRoleWhat they receive
1ExperimentalPatients will receive RTU TPN with olive-oil as the primary source of lipids
Receives: Dietary Supplement: RTU TPN with olive oil as the primary lipid source
2Active comparatorCNF parenteral nutrition made with olive oil as the primary source of lipids
Receives: Other: CNF Parenteral nutrition
3Active comparatorCNF parenteral nutrition made with LCT/MCT as the primary source of lipids
Receives: Other: CNF parenteral nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28-day follow up

Secondary outcomes (8)

  1. 28-days all cause mortality

    Measured: 28-days follow-up period

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

    Measured: Time from prescription to the effective start of TPN

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

    Measured: For the duration of TPN

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

    Measured: For the duration of TPN

  5. 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)

    Measured: For the duration of TPN

  6. Use of hospital/ICU resources such as vasopressors, mechanical ventilation, need of hemodialysis, need of inotropic agents, antibiotics and sedatives

    Measured: 28-days follow-up period

  7. ICU-free days, defined as the number of days from study entry (baseline) to the actual day that a patient remained on the ICU during the 28-days follow up period

    Measured: 28-days follow-up period

  8. Number of new organ failures

    Measured: 28-days follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00798681
Sponsor's protocol ID
HFT-001/2008-BR
Acronym
EPICOS
Status last verified
Jul 2010
First submitted
25 Nov 2008
Last updated
10 Aug 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22269899

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RTU TPN with olive oil as the primary lipid source and CNF Parenteral nutrition in people with Parenteral Nutrition, run by Fernandes Tavora Hospital at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil, Argentina, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 28-day follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00798681, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.

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