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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106624
• Other study ID #: HiNiCi
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• nitrogen supply
Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.

Locations

Country	Name	City	State
China	Division of Critical Care Medicine: Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		28 days
Primary	all cause mortality		90 days
Secondary	duration on ventilators		patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
Secondary	ICU stay		patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
Secondary	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
Secondary	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
Secondary	diameter of midpoint of musculus rectus femoris	diameter of the muscle is measured with percutaneous ultrasound	on 28th. day or endpoint of the trial
Secondary	serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin		on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
Secondary	change of body composition		on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment