- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815527
Time to Protein Target Using a High Whey Protein Enteral Nutrition in Critically Ill Patients
Time to Protein Target, the 'HIGH WHEY' Study A Prospective Pilot Study
Study Overview
Detailed Description
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Noord Holland
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Amsterdam, Noord Holland, Netherlands
- VU Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fresubin Intensive
Adult critically ill non-septic ventilated patients admitted to the intensive care unit with an expected intensive care stay of four days or more.
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Enteral nutrition containing a high protein concentration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Protein target
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96 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein intake 48 hours and 96 hours after start (g/day)
Time Frame: 48 and 96 hours
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Protein intake
|
48 and 96 hours
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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
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Gastro-intestinal tolerance
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During 96 hours
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Plama leucine concentration (μmol/L)
Time Frame: 0, 48, and 96 hours
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Amino acid plasma concentration
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0, 48, and 96 hours
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Muscle mass (kg)
Time Frame: 48 and 96 hours
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Measured using bioimpedance analysis
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48 and 96 hours
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Plasma urea concentration (mmol/l)
Time Frame: 48 and 96 hours
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Metabolic tolerance
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48 and 96 hours
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Cumulative protein intake 96 hours after start of the study formula (grams)
Time Frame: 96 hours
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Cumulative protein intake
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96 hours
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Time to protein target (protein intake ≥ 1.2 g/kg/day).
Time Frame: Up to 96 hours
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Time to target
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Up to 96 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heleen M. Oudemans-van Straaten, MD. Prof., Amsterdam UMC, location VUmc
Publications and helpful links
General Publications
- Meyer R, Foong RX, Thapar N, Kritas S, Shah N. Systematic review of the impact of feed protein type and degree of hydrolysis on gastric emptying in children. BMC Gastroenterol. 2015 Oct 15;15:137. doi: 10.1186/s12876-015-0369-0.
- Marik PE. Feeding critically ill patients the right 'whey': thinking outside of the box. A personal view. Ann Intensive Care. 2015 Dec;5(1):51. doi: 10.1186/s13613-015-0051-2. Epub 2015 May 28.
- Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
- Stapel SN, de Grooth HJ, Alimohamad H, Elbers PW, Girbes AR, Weijs PJ, Oudemans-van Straaten HM. Ventilator-derived carbon dioxide production to assess energy expenditure in critically ill patients: proof of concept. Crit Care. 2015 Oct 22;19:370. doi: 10.1186/s13054-015-1087-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.560
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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