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Protein intake, tolerance and safety of a new high protein tube feed in critically ill overweight ICU patients as compared to standard tube feed.

Protein intake, gastro intestinal tolerance and safety after administration of a new high protein tube feed in critically ill overweight ICU patients as compared to an isocaloric standard tube feed.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28901
Enrollment
44
Registered
2016-02-02
Start date
2016-02-15
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

Catabolic state induced by severe diseases

Interventions

Duration of intervention: 28 days Intervention group: High protein tube feed Control group: Isocaloric control tube feed

Sponsors

Nutricia Research B.V. Uppsalalaan 12, 3584 CT Utrecht - The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years and over - Male and female - Patient: ICU stay and indication for tube feed via nasogastric tube - BMI > 25.0 kg/m2

Exclusion criteria

Exclusion criteria: - Requiring other specific tube feed for medical reason. - Having any contra-indication to receive tube feed such as severe shock, presence of partial or complete mechanical bowel obstruction, or intestinal ischemia or infarction. - Abnormalities in GI tract which may impact GI function, such as short bowel syndrome - defined as entire length of small bowel totalling 122 centimetres or less-, Ulcerative Colitis or Crohn’s disease or any form of enterostomy - GI tract, abdominal or bariatric surgery within 72 hours before start intake study product or expected in the next 5 days after start study product intake - History of chronic pancreatitis or acute pancreatitis - Expected to need parenteral feeding - Expected to need protein supplementation other than study product - SOFA score >12 from admission to the ICU until 24 hours after admission or until randomisation in case of randomisation before 24 hours after admission

Design outcomes

Primary

MeasureTime frame
protein intake (g/kg BW/day)

Secondary

MeasureTime frame
gastro intestinal tolerance, energy intake and safety

Contacts

Public ContactGerben Hofman
Gerben.Hofman@Nutricia.comT: +31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)