Gastrointestinal tolerance in ICU patients after administration of an energy and protein enriched peptide formula as compared to an isocaloric standard tube feed

Phase 2

Conditions: Het voordoen van tolerantieproblemen bij sondevoeding
gastrointestinal intolerance in critically ill patients

Registration Number: NL-OMON45321

Lead Sponsor: utricia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>No primary outcome is defined, because gastrointestinal tolerance cannot be<br /><br>described by one single symptom (Reintam Blaser 2014).<br /><br><br /><br>The main outcome parameter is gastrointestinal tolerance measured by:<br /><br>- Time period till first defecation since start study product<br /><br>- Defecation frequency<br /><br>- Defecation consistency based on Bristol Stool Form Scale (BSFS)<br /><br>- Incidence of diarrhoea, constipation and vomiting<br /><br>- Daily gastric residual volume<br /><br>- Daily intake of study product<br /><br>- Daily energy and protein intake from study product</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other parameters in this study are:<br /><br>- Faecal weight and consistency based on King*s Stool Chart<br /><br>- Duration of ICU stay<br /><br>- Length of hospital stay<br /><br>- Ventilator free days<br /><br>- ICU, hospital and 28-day mortality<br /><br>- SOFA (sub) score(s)<br /><br>- Gastric pH<br /><br>- Serum concentration of amino acids<br /><br>- Protein absorption</p><br>