The objective of this study is to compare gastrointestinal tolerance in ICU patients during administration of an upgraded peptide based tube feed product to an isocaloric standard tube feed during a period of maximal two weeks.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het voordoen van tolerantieproblemen bij sondevoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No primary outcome is defined, because gastrointestinal tolerance cannot be
described by one single symptom (Reintam Blaser 2014).
The main outcome parameter is gastrointestinal tolerance measured by:
- Time period till first defecation since start study product
- Defecation frequency
- Defecation consistency based on Bristol Stool Form Scale (BSFS)
- Incidence of diarrhoea, constipation and vomiting
- Daily gastric residual volume
- Daily intake of study product
- Daily energy and protein intake from study product
Secondary outcome
Other parameters in this study are:
- Faecal weight and consistency based on King*s Stool Chart
- Duration of ICU stay
- Length of hospital stay
- Ventilator free days
- ICU, hospital and 28-day mortality
- SOFA (sub) score(s)
- Gastric pH
- Serum concentration of amino acids
- Protein absorption
Background summary
Feeding the patients on an intensive care unit (ICU) is challenging. Most ICU
patients are sedated and need to be tube fed. Medications and sedation reduce
the absorption and tolerance to tube feed, leading to stomach and intestinal
complaints like diarrhoea and poor feed absorption. This results in lower
intake of the tube feed, weight loss (especially muscle) and a worsened
clinical outcome.
Tube feeds normally used at the ICU are with intact nutrients like intact
protein. Peptide feeds are recommended for patients with persistent diarrhoea.
Nutricia has a peptide feed on the market that is being used in ICU patients
for more than 15 years. The energy and protein content of this peptide feed is
increased to meet the new nutritional recommendations for feeding ICU patients.
Additionally, a different peptide source is being used which might give less
stomach and intestine complaints.
The purpose of this study is to compare the gastrointestinal tolerance of this
adapted peptide feed to a standard isocaloric tube feed after administration to
ICU patients.Patients will received the peptide feed or the standard tube feed
for up to 2 weeks. This study will give more insight in the tolerance of the
adapted peptide feed.
Study objective
The objective of this study is to compare gastrointestinal tolerance in ICU
patients during administration of an upgraded peptide based tube feed product
to an isocaloric standard tube feed during a period of maximal two weeks.
Study design
This is a randomised, controlled, double blind, parallel-group, multi-country,
multi-centre study on gastrointestinal tolerance.
Intervention
Administration of a tube feed different than the standard used tube feeds for a
period of max 14 days.
Study burden and risks
Most assessments are standard practice at the ICU or done in routinely
collected blood samples or urine samples. As such, no major issues are foreseen
on the burden of the patient.
The test product is an adaptation of a commercially available peptide feed. No
issues have been reported for this peptide feed for more than 15 years. The
adaptation is done according to the most recent guidlines on feeding ICU
patients (more protein and energy). Therefore, we don*t expect any issues
regarding the use of this adapted peptide feed. The control product is a
commercial available tube feed. Like in every clinical trial subjects will be
closely monitored for (serious) adverse events.
If it appears that a patient needs a specific tube feed (e.g. diabetic tube
feed), then the administration of the study product will be stopped and feeding
with the required specific tube feed will be started. The physician will decide
which specific tube feed should be used in the best interest of the patient.
The participants receiving the upgraded peptide feed might potentially benefit,
because the upgraded peptide feed might be better tolerated. Improved GI
tolerance might improve nutritional status and consequently minimize weight
loss. This will favour recovery and improve quality of life post-discharge.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
- Age ><=18 years;
- Admitted to the ICU;
- Expected to be on tube feeding for ><=5 days;
- Start of tube feeding within 48 hours after ICU admission
Exclusion criteria
- Requiring other tube feed for medical reason;
- Not suitable for tube feeding;
- Allergy or intolerance for cow*s milk protein, soy or pea protein;
- Gastrointestinal disease such as Crohn*s or Ulcerative Colitis or other conditions affecting absorption such as short bowel syndrome;
- Pancreatic, liver or renal failure;
- Sequential organ failure assessment (SOFA) score >12 within first 24 hours after admission;
- Being pregnant;
- Participating in another clinical intervention trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58904.072.16 |