Critically IllNCT02106624
A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients
A study testing nitrogen supply in people with Critically Ill, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- nitrogen supply
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Critical Care Medicine: Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
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
- Being tested
- nitrogen supply
- Keywords
- mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrogen supplyOther
Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| High Nitrogen | Experimental | In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight) Receives: 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 Receives: Other: nitrogen supply |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days
all cause mortality
Measured: 90 days
Secondary outcomes (7)
duration on ventilators
Measured: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
ICU stay
Measured: patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
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.
Measured: 28 days
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.
Measured: on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment
diameter of midpoint of musculus rectus femoris
diameter of the muscle is measured with percutaneous ultrasound
Measured: on 28th. day or endpoint of the trial
serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
Measured: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
change of body composition
Measured: on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106624
- Sponsor's protocol ID
- HiNiCi
- Status last verified
- May 2020
- First submitted
- 30 Mar 2014
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT02106624
- Acronym / sponsor ID
- HiNiCi
- Conditions
- Critically Ill
- Keywords
- mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Nitrogen | Experimental | Other: nitrogen supplyIn this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight) |
| conventional nitrogen | Active comparator | Other: nitrogen supplyIn this arm, daily nitrogen supply is 1.2-1.5g per kilogram (lean mass weight) as recommended by ESPEN guideline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- irreversible status of primary disease
- any history of malnutrition before enrollment
- history of steroid cortisol administration
- severe liver dysfunction (Child-Pugh Score C)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrogen supplyNitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition. | Other | High Nitrogen, conventional nitrogen |
Primary outcome
all cause mortality
Time frame: 28 days
all cause mortality
Time frame: 90 days
7 secondary outcomes
duration on ventilators
Time frame: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
ICU stay
Time frame: patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
infection incidence rate
Time frame: 28 days
Liver function and renal function
Time frame: on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment
diameter of midpoint of musculus rectus femoris
Time frame: on 28th. day or endpoint of the trial
serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
Time frame: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
change of body composition
Time frame: on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrogen supply in people with Critically Ill, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.