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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45321

Enrollment

Registered

2017-04-14

Start date

2017-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Administration of a tube feed different than the standard used tube feeds for a period of max 14 days.

Gastrointestinal tolerance

ICU patients

tube feed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age >

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)