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

NCT02106624 | Completed DMC

• 1 other identifier: HiNiCi
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• all cause mortality

  28 days

• all cause mortality

  90 days

Secondary Outcomes (7)

• 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

  28 days

• Liver function and renal function

  on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment

• diameter of midpoint of musculus rectus femoris

  on 28th. day or endpoint of the trial

Study Arms (2)

High Nitrogen

EXPERIMENTAL

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

Other: nitrogen supply

conventional nitrogen

ACTIVE COMPARATOR

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

Other: nitrogen supply

Interventions

nitrogen supply OTHER

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

High Nitrogen; conventional nitrogen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Division of Critical Care Medicine: Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Division of Critical Care Medicine

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

CN (1)