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

NCT ID: NCT02106624

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-05-31

Brief Summary

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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

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Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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High Nitrogen

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

Group Type EXPERIMENTAL

nitrogen supply

Intervention Type OTHER

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

conventional nitrogen

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

Group Type ACTIVE_COMPARATOR

nitrogen supply

Intervention Type OTHER

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

Interventions

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nitrogen supply

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Zhong

Associate Professor of Division of Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Critical Care Medicine: Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HiNiCi

Identifier Type: -

Identifier Source: org_study_id

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