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

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

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 Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: nitrogen supply

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Division of Critical Care Medicine: Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: mechanical ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HiNiCi