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

NCT ID: NCT02815527

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-09-30

Brief Summary

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.

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)

Conditions

Critically Ill

Keywords

enteral nutrition; intensive care unit; whey; protein; muscle mass; leucin; energy expenditure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Fresubin intensive

Intervention Type: OTHER

Enteral nutrition containing a high protein concentration

Interventions

Fresubin intensive

Enteral nutrition containing a high protein concentration

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

H.M. Oudemans-van Straaten, MD, PhD

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heleen M. Oudemans-van Straaten, MD. Prof.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

VU Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 26472544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26055186 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25499096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26494245 (View on PubMed)

Other Identifiers

2015.560

Identifier Type: -

Identifier Source: org_study_id