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

Completed

• Conditions: Critically Ill
• Interventions: Other: Fresubin intensive

• Registration Number: NCT02815527
• Lead Sponsor: Amsterdam UMC, location VUmc

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)

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-28
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fresubin Intensive	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma urea concentration (mmol/l)	48 and 96 hours	Metabolic tolerance
Protein intake 48 hours and 96 hours after start (g/day)	48 and 96 hours	Protein intake
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	Gastro-intestinal tolerance
Plama leucine concentration (μmol/L)	0, 48, and 96 hours	Amino acid plasma concentration
Muscle mass (kg)	48 and 96 hours	Measured using bioimpedance analysis
Cumulative protein intake 96 hours after start of the study formula (grams)	96 hours	Cumulative protein intake
Time to protein target (protein intake ≥ 1.2 g/kg/day).	Up to 96 hours	Time to target

Trial Locations

Locations (1)

VU Medical Center; 🇳🇱 Amsterdam, Noord Holland, Netherlands