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

Shanghai Zhongshan Hospital89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Critically Ill

Interventions

nitrogen supplyOTHER

Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Critical Care Medicine: Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

all cause mortality

Time frame: 28 days

all cause mortality

Time frame: 90 days

Secondary Outcomes

duration on ventilators

Time frame: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks

ICU stay

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: on 28th. day or endpoint of the trial

serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin

Time frame: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment

change of body composition

Data from ClinicalTrials.gov

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