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NCT Number: NCT02815527

Time to Protein Target Using a High Whey Protein Enteral Nutrition in Critically Ill Patients

This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated ICU patients. The primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VU Medical Center

Amsterdam, North Holland, Netherlands

About this study

In the present pilot study, the investigators will use a high whey-protein nutrition formula during the first four days of ICU admission. The reason for using a high protein nutrition is that the investigators previously found that an early high protein intake in non-septic non-overfed patients was associated with lower hospital mortality (Weijs PJM et. al., Critical Care 2014,18). Furthermore, during the first days of critical illness tolerance to full enteral nutrition is often diminished. The use of a high protein nutrition will facilitate an early high protein intake.

The whey protein is hydrolysed. Hydrolyzation of protein prevents coagulation and subsequent solidification in the digestive tract and therefore promotes efficient absorption of the protein. Of all nutrition proteins, whey protein has the largest leucin content. Leucin is crucial for muscle protein synthesis. (Meyer RF, et.al.: BMC Gastroenterol 2015, 15), (Marik PE: Ann Intensive Care 2015,5:51)

Our previous observational data also showed that early overfeeding was associated with higher mortality, while an intake of 80-100% of measured energy expenditure at day 4 of ICU admission was associated with lower mortality. (Weijs PJM et. al., Critical Care 2014, 18)

Therefore, the energy target during the first four days will be 90% of the measured Energy Expenditure (EE). To optimize energy intake, the investigators will measure EE by metabolic monitoring (Deltatrac®, Datex, Helsinki, Finland), If metabolic monitoring is not available, the investigators will assess EE from the ventilator derived VCO2 (8.19*VCO2). (Stapel S, et.al., Critical Care 2015,19:370)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission to the intensive care unit
  • Age >18 years
  • Mechanical ventilation
  • Expected intensive care stay of four days or longer

Exclusion criteria

  • Contraindication for enteral nutrition (gut ischemia, obstruction or perforation)
  • Expected intolerance for enteral nutrition (paralytic ileus)
  • Inability to start enteral nutrition within 24-hours due to logistic reasons (i.e. surgery or other interventions)
  • Short bowel syndrome
  • Child C liver cirrhosis or acute liver failure
  • Dialysis dependency
  • Requiring other specific enteral nutrition for medical reason
  • Extensive treatment limitations
  • Written deferred patient or proxy consent is not obtained
  • Participation in another intervention study
  • Inability to measure energy expenditure (pulmonary air leakage)

Treatment and study plan

Fresubin intensive

Other

Enteral nutrition containing a high protein concentration

Primary outcomes

  1. The proportion of patients reaching the individualized protein target (≥1.2 g/kg ideal body weight/day) 96 hours after ICU admission

    Time frame: 96 hours

    Protein target

Secondary outcomes

  1. Protein intake 48 hours and 96 hours after start (g/day)

    Time frame: 48 and 96 hours

    Protein intake

  2. Number of patients with adverse events related to nutrition, as defined by: high gastric retention,abdominal distension, vomiting, diarrhea, need of prokinetics or duodenal tube

    Time frame: During 96 hours

    Gastro-intestinal tolerance

  3. Plama leucine concentration (μmol/L)

    Time frame: 0, 48, and 96 hours

    Amino acid plasma concentration

  4. Muscle mass (kg)

    Time frame: 48 and 96 hours

    Measured using bioimpedance analysis

  5. Plasma urea concentration (mmol/l)

    Time frame: 48 and 96 hours

    Metabolic tolerance

  6. Cumulative protein intake 96 hours after start of the study formula (grams)

    Time frame: 96 hours

    Cumulative protein intake

  7. Time to protein target (protein intake ≥ 1.2 g/kg/day).

    Time frame: Up to 96 hours

    Time to target

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Time to Protein Target, the 'HIGH WHEY' Study A Prospective Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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