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

Primary Purpose

Critically Ill

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nitrogen supply
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring mechanical ventilation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Critical Care Medicine: Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Nitrogen

conventional nitrogen

Arm Description

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

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

Outcomes

Primary Outcome Measures

all cause mortality
all cause mortality

Secondary Outcome Measures

duration on ventilators
ICU stay
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.
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.
diameter of midpoint of musculus rectus femoris
diameter of the muscle is measured with percutaneous ultrasound
serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
change of body composition

Full Information

First Posted
March 30, 2014
Last Updated
May 23, 2020
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02106624
Brief Title
A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients
Official Title
The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Nitrogen
Arm Type
Experimental
Arm Description
In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight)
Arm Title
conventional nitrogen
Arm Type
Active Comparator
Arm Description
In this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline
Intervention Type
Other
Intervention Name(s)
nitrogen supply
Intervention Description
Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
28 days
Title
all cause mortality
Time Frame
90 days
Secondary Outcome Measure Information:
Title
duration on ventilators
Time Frame
patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
Title
ICU stay
Time Frame
patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
Title
infection incidence rate
Description
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
Title
Liver function and renal function
Description
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
Title
diameter of midpoint of musculus rectus femoris
Description
diameter of the muscle is measured with percutaneous ultrasound
Time Frame
on 28th. day or endpoint of the trial
Title
serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
Time Frame
on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
Title
change of body composition
Time Frame
on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Critical Care Medicine: Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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

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