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.

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. - PROTILL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42168

Enrollment

Registered

2015-08-18

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

None listed

Interventions

Providing a tube feed to the subject other than standard care for a maximum duration of 28 days. Collecting a maximum of 70 ml. blood. Follow-up call (if applicable)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age * 18 years. 2. ICU stay and indication for tube feed via nasogastric tube. 3. Expected to require study product for at least 5 days on the ICU 4. 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 totaling 122 centimeters 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

Measure	Time frame
The primary outcome parameter in this study is protein intake (g/kg body weight/day)	—

Secondary

Measure	Time frame
To evaluate gastro intestinal tolerance, energy intake and safety of the test product compared to the control product.	—

Countries

Netherlands

Outcome results