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

Not Applicable

Completed

• Conditions: Critically Ill
• Interventions: Other: nitrogen supply

• Registration Number: NCT02106624
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-30
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Study Start: 2015-03
• Primary Completion: 2020-01
• Status Verified: 2020-05
• Study Completion: 2020-05
• Last Update Submitted: 2020-05-23
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional nitrogen	nitrogen supply	In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline
High Nitrogen	nitrogen supply	In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight)

Primary Outcome Measures

Name	Time	Method
all cause mortality	90 days

Secondary Outcome Measures

Name	Time	Method
change of body composition	on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
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	28 days	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.
Liver function and renal function	on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment	Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine.
diameter of midpoint of musculus rectus femoris	on 28th. day or endpoint of the trial	diameter of the muscle is measured with percutaneous ultrasound
serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin	on 7th. day , 14th. day, 21st. day, 28th. day after enrollment

Trial Locations

Locations (1)

Division of Critical Care Medicine: Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China