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NCT Number: NCT02106624

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

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Critical Care Medicine: Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nitrogen supply

Other

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

Primary outcomes

  1. all cause mortality

    Time frame: 28 days

  2. all cause mortality

    Time frame: 90 days

Secondary outcomes

  1. duration on ventilators

    Time frame: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks

  2. ICU stay

    Time frame: patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks

  3. infection incidence rate

    Time frame: 28 days

    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.

  4. Liver function and renal function

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

    Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine.

  5. diameter of midpoint of musculus rectus femoris

    Time frame: on 28th. day or endpoint of the trial

    diameter of the muscle is measured with percutaneous ultrasound

  6. serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin

    Time frame: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment

  7. change of body composition

    Time frame: on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2014
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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