Trial document





This trial has been registered retrospectively.
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  DRKS00000104

Trial Description

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Title

Hypocaloric nutrition in intensive care medicine and its clinical relevance

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is not yet clear how critically ill medical patients should be fed during the phase of acute illness. There is no evidence that a normocaloric feeding (caloric supply and expenditure are equal) would positively influence the clinical outome. Results from observational studies show that these patients may benefit from a hypocaloric (caloric supply lower than expenditure) than from a normocaloric feeding. The aim of this study is to compare hypocaloric and normocaloric feeding in critically ill medical patients who require artificial feeding in the first seven days of acute illness.

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Brief Summary in Scientific Language

The question of optimal nutrition of critically ill medical patients, at least during the phase of the acute illness, is not yet answered. There is no evidence on the merits of normocaloric feeding. Current observations show, particularly since the increasing use of enteral feeding, that most of these patients receive less calories than their expenditure. There is also evidence from observational studies that hypocaloric feeding may be beneficial regarding infection rate and length of stay in critical care facilities. This propsective randomised single-blinded study is aimed to test the effect of hypocaloric (defined as 50% of measured or calculated energy expenditure) versus normocaloric feeding on metabolic parameters, infection rate and length of ICU stay among critically ill medical patients requiring artificial feeding during the first seven days of acute illness

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Organizational Data

  •   DRKS00000104
  •   2009/03/26
  •   [---]*
  •   yes
  •   Approved
  •   153-2008, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Critically ill internal patients, who need parenteral nutrition during the first seven days of acute illness
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Interventions/Observational Groups

  •   normocaloric nutrition (100% of the measured or calculated energy expenditure)
  •   hypocaloric nutrition (50% of measured or calculated energy expenditure)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Other
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Rate of nosocomial infection (microbiological diagnosis of tracheal secretion, urin and blood culture, clinical and radiological criteria of nosocomial infection)

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Secondary Outcome

- Glycemic control and insulin demand (Blood glucose control every 3 hours, documentation of insulin demand to maintain a blood glucose level of 8-10 mmol/l)
- intensive care unit survival
- hospital survival
- 28-day survival

Data acquistion from hospital charts, telephone interview if patient discharged before day 28 (questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/10/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

critically ill medical patients, which require artificial nutrition for at least three days

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Exclusion Criteria

- underweight patients (defined as a body mass index of less than 19) or pre-existent malnutrition
- refusal to participate in the study by the patient or guardian
- probable length of ICU stay less than 3 days
- no need for artificial nutrition
- pregnancy
- immune suppression
- transplantation
- chemotherapy
- surgical patients
- burns
- age under 18 years or over 80 years
- participation in another trial

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Leipzig AöR, Department für Innere Medizin, Interdisziplinäre Internistische Intensivmedizin
    • Mr.  PD Dr. med.   Sirak  Petros 
    • Liebigstr. 20
    • 04103   Leipzig
    • Germany
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    • Department für Innere Medizin Internistische Intesivmedizin
    • Mr.  Dr. med.  Sirak  Petros 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Department für Innere Medizin und Dermatologie Interdisziplinäre Internistische Intensivmedizin
    • Mr.  Dr. med.  Lorenz  Weidhase 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Department für Innere Medizin Internistische Intensivmedizin
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/02/28
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Trial Publications, Results and other Documents

  •   Petros S, Horbach M, Seidel F, Weidhase L. (2014):Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial. JPEN J Parenteral Enteral Nutr. Apr 3
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* This entry means the parameter is not applicable or has not been set.