The Effect of peptide-based formula compared with isocaloric, isonitrogenous formula by early enteral feeding in critically-ill patients

Phase 3

Recruiting

• Conditions: Critically-ill patients who admitted on Surgical ICU ward and can start tube feeding after 48 hr post-operation.; Peptide-based formula; tube feeding; critically-ill; Surgical ICU

• Registration Number: TCTR20220507003
• Lead Sponsor: Thai Otsuka Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-07
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1.Willing to participate clinical study with signing consent form
2.Age 15 year or above
3.Admit on Surgical ICU ward
4.Tend to be prescribed tube feeding in ICU at least 5 days and up to 14 days
5.Risk of malnutrition on mild to moderate by BNT assessment
6.BMI 18-40 kg/m2
7.Can be assigned tube feeding within 48 hr after operation
8.Haemodynamic stable. In case of taking norepinephrine, would take not more than 15 microgram/min or 0.3 microgram/kg/min

Exclusion Criteria

1. Experiences aspiration pneumonia
2. Experiences thyroid disease
3. Experiences severe hepatic impairment
4. Diagnosed to ascites
5. Diagnosed to CKD or renal replacement therapy
6. Diagnosed to abdominal hypertension or fluid overload
7. Takes fentanyl more than 2 microgram per kg per hr or morphine more than 0.05 milligram per kg per hr
8. Has parenteral nutrition administration
9. Experiences food allergy such as Whey Protein, Casein ,
10 Diagnosed to incurable disease that could not participate the study such as uncontrolled cancer,
11 Experiences chemotherapy or radiotherapy within 6 months ago. (including immunosuppressor taking such as prednisolone 7 days continuously within 4 months before enrolment ,
12 Experiences immune disorder such as HIV-positive
13. Diagnosed to burn at severity level 2 or 3 with wound 50% of total body surface area
14. Taking tube feeding less than 70% of total requirement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily average gastric residual volume every time before feeding IP Gastric Residual Volume measurement,Fibronectin change Day1,3,5,11,14 Fibronectin level

Secondary Outcome Measures

Name	Time	Method
utrition status Day1,3,5,7,9,11,14 retinol binding protein, prealbumin, albumin,total lymphocyte count Day 1,3,5,7,9,11,14 CBC,nitrogen balance Day 1,3,5,7,9,11,14 UUN,ICU length of stay Everyday during the study assessment,ICU mortality Everyday during the study assessment ,duration of hospitalization Everyday during the study assessment ,GI side effect Everyday during the study assessment ,Rate of infection Everyday during the study assessment