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

NCT02815527 | Completed

• 1 other identifier: 2015.560
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

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

Outcome Measures

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

  Protein target

  96 hours

Secondary Outcomes (7)

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

  48 and 96 hours

• 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

  During 96 hours

• Plama leucine concentration (μmol/L)

  0, 48, and 96 hours

• Muscle mass (kg)

  48 and 96 hours

• Plasma urea concentration (mmol/l)

  48 and 96 hours

Study Arms (1)

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.

Other: Fresubin intensive

Interventions

Fresubin intensive OTHER

Enteral nutrition containing a high protein concentration

Fresubin Intensive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ventilated critically ill patients in the ICU

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 26472544 BACKGROUND

• 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.

  PMID: 26055186 BACKGROUND

• 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.

  PMID: 25499096 BACKGROUND

• 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.

  PMID: 26494245 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: June 28, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)