Critically IllNCT02815527
Time to Protein Target Using a High Whey Protein Enteral Nutrition in Critically Ill Patients
An observational study of Critically Ill, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Fresubin intensive
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ventilated critically ill patients in the ICU
Who may be able to join
- Admission to the intensive care unit
- Age >18 years
- Mechanical ventilation
- Expected intensive care stay of four days or longer
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time to Protein Target, the 'HIGH WHEY' Study A Prospective Pilot Study
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.
Read the 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
- Being tested
- Fresubin intensive
- Keywords
- enteral nutrition, intensive care unit, whey, protein, muscle mass, leucin, energy expenditure
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin intensiveOther
Enteral nutrition containing a high protein concentration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fresubin intensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients reaching the individualized protein target (≥1.2 g/kg ideal body weight/day) 96 hours after ICU admission
Protein target
Measured: 96 hours
Secondary outcomes (7)
Protein intake 48 hours and 96 hours after start (g/day)
Protein intake
Measured: 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
Gastro-intestinal tolerance
Measured: During 96 hours
Plama leucine concentration (μmol/L)
Amino acid plasma concentration
Measured: 0, 48, and 96 hours
Muscle mass (kg)
Measured using bioimpedance analysis
Measured: 48 and 96 hours
Plasma urea concentration (mmol/l)
Metabolic tolerance
Measured: 48 and 96 hours
Cumulative protein intake 96 hours after start of the study formula (grams)
Cumulative protein intake
Measured: 96 hours
Time to protein target (protein intake ≥ 1.2 g/kg/day).
Time to target
Measured: Up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.M. Oudemans-van Straaten, MD, PhD, Amsterdam UMC, location VUmc
- Investigators
- Heleen M. Oudemans-van Straaten, MD. Prof., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815527
- Sponsor's protocol ID
- 2015.560
- Status last verified
- Nov 2017
- First submitted
- 9 May 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26472544Marik 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.
PubMed 26055186Weijs 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.
PubMed 25499096Stapel 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.
PubMed 26494245
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Protein Target, the 'HIGH WHEY' Study A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02815527
- Acronym / sponsor ID
- 2015.560
- Conditions
- Critically Ill
- Keywords
- enteral nutrition, intensive care unit, whey, protein, muscle mass, leucin, energy expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fresubin Intensive | – | Other: Fresubin intensiveAdult critically ill non-septic ventilated patients admitted to the intensive care unit with an expected intensive care stay of four days or more. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ventilated critically ill patients in the ICU
Key inclusion criteria (4 listed)
- Admission to the intensive care unit
- Age >18 years
- Mechanical ventilation
- Expected intensive care stay of four days or longer
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresubin intensiveEnteral nutrition containing a high protein concentration | Other | Fresubin Intensive |
Primary outcome
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
7 secondary outcomes
Protein intake 48 hours and 96 hours after start (g/day)
Time frame: 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
Time frame: During 96 hours
Plama leucine concentration (μmol/L)
Time frame: 0, 48, and 96 hours
Muscle mass (kg)
Time frame: 48 and 96 hours
Plasma urea concentration (mmol/l)
Time frame: 48 and 96 hours
Cumulative protein intake 96 hours after start of the study formula (grams)
Time frame: 96 hours
Time to protein target (protein intake ≥ 1.2 g/kg/day).
Time frame: Up to 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 26472544Meyer 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.
- Background: PubMed 26055186Marik 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.
- Background: PubMed 25499096Weijs 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.
- Background: PubMed 26494245Stapel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heleen M. Oudemans-van Straaten, MD. Prof. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815527, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.