A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients

Study Overview
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Brief Summary
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The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators. The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.

Official Title
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The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial

Conditions
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Critically Ill

Intervention / Treatment
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* Other: nitrogen supply


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: need mechanical ventilation for more than 2 days mean blood pressure more than 60mmHg predicted ICU stay more than 7 days tolerance of parenteral or enteral nutrition Exclusion Criteria: irreversible status of primary disease any history of malnutrition before enrollment history of steroid cortisol administration severe liver dysfunction (Child-Pugh Score C) pregnancy refuse to enrollment re-admission to ICU and has been enrolled during former admission to ICU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Nitrogen<br>In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight) | Other: nitrogen supply<br>* Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.<br>|
| Active Comparator: conventional nitrogen<br>In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline | Other: nitrogen supply<br>* Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 28 days | 
| all cause mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration on ventilators |  | patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks | 
| ICU stay |  | patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks | 
| infection incidence rate | Details of infection includes pneumonia, catheter-related blood stream infection, urinary tract infect, et al. Diagnosis of infection accords to symptoms, lab tests, imaging measurements and bacterial cultures. | 28 days | 
| Liver function and renal function | Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine. | on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment | 
| diameter of midpoint of musculus rectus femoris | diameter of the muscle is measured with percutaneous ultrasound | on 28th. day or endpoint of the trial | 
| serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin |  | on 7th. day , 14th. day, 21st. day, 28th. day after enrollment | 
| change of body composition |  | on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation