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

Fudan University

Status: Completed

Conditions: Critically Ill

Treatments: Other: nitrogen supply

Study type: Interventional

Funder types: Other

Identifiers

NCT02106624

HiNiCi

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 2 patient groups

High Nitrogen

Experimental group

Description:

In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight)

Treatment:

Other: nitrogen supply

conventional nitrogen

Active Comparator group

Description:

In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline

Treatment:

Other: nitrogen supply