AzTrials
AzTrials

Neurological DisorderNCT06510712

Nutritional Risk for Hospitalized Patients With Neurology Disorders in China

An observational study of Neurological Disorder, run by Xuanwu Hospital, Beijing.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neurology disorders are one of the major public health problems that seriously threaten human health. It often accompanied by various nutritional problems, which can aggravate the primary disease, lead to serious complications, prolong the hospitalization, lead to poor prognosis, and increase family and social… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurological Disorder
How many people
10,000 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 30 Jun 2026
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with the primary diagnosis are neurological disoders

Who may be able to join

  • Age ≥ 18 years;
  • The primary diagnosis was neurological disorders;
  • Written informed consent.

Who cannot join

  • Life expectancy is < 3 months;
  • Researchers think other ineligible participant for the study.

Trial locations and contacts

No sites are listed yet.

Gaoting Ma, PhD contact

18301579891

demo_doctor@163.com

About this study

Official title: Nutritional Risk and Health Research for Hospitalized Patients With Neurology Disorders in China

Neurology disorders are one of the major public health problems that seriously threaten human health. It often accompanied by various nutritional problems, which can aggravate the primary disease, lead to serious complications, prolong the hospitalization, lead to poor prognosis, and increase family and social economic burdens. According to the previous studies, the risk of malnutrition was approximately 58.5% of stroke patients, and 6% had moderate to severe malnutrition in China. Another study conducted in Beijing showed that the risk of malnutrition of elderly patients in the department of neurology was significantly higher than in other departments (28.5% vs. 26.4%). Strengthening nutritional supervision of patients with neurology disorders will benefit to improve patients' prognosis. Therefore, the aim of this study is to investigate the nutritional status of inpatients with neurology disorders in China, evaluate the impact of different nutritional status on patients' health outcomes, and establish a high-quality, standardized nutrition and health cohort database for neurology disorders.

Keywords
nutrition, the risk of malnutrition
Medical subject headings
Nervous System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Mortality defined as all-cause mortality from inclusion to day 30

    Measured: 30 days

Secondary outcomes (5)

  1. ICU admission

    ICU admission defined as admission to the intensive care unit from the medical ward from inclusion to day 30

    Measured: 30 days

  2. Non-elective hospital readmission

    Non-elective hospital readmission defined as non-scheduled hospital readmission after discharge from the index hospital stay to day 30

    Measured: 30 days

  3. Major complications

    Major complications defined as the following complications occurring from inclusion (i.e., not present at the time of inclusion) to day 30 I. Adjudicated nosocomial infection or abscess requiring antibiotic treatment II. respiratory failure with need for invasive or non-invasive ventilation III. major cardiovascular events including stroke, intracranial bleeding, cardiac arrest, myocardial infarction with and without invasive procedure and pulmonary embolism IV. acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis do to volume overload or electrolyte disturbance) V. gastro-intestinal events (hemorrhage, intestinal perforation)

    Measured: 30 days

  4. Decline in functional status of 10% or more

    decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index.

    Measured: 30 days

  5. length of in hospital days

    Total length of in hospital days 30 days

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510712
Sponsor's protocol ID
X-MEC-2024-001
Status last verified
Jul 2024
First submitted
14 Jul 2024
Last updated
19 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PubMed 34487721

  • Wang YJ, Li ZX, Gu HQ, Zhai Y, Jiang Y, Zhao XQ, Wang YL, Yang X, Wang CJ, Meng X, Li H, Liu LP, Jing J, Wu J, Xu AD, Dong Q, Wang D, Zhao JZ; China Stroke Statistics 2019 Writing Committee. China Stroke Statistics 2019: A Report From the National Center for Healthcare Quality Management in Neurological Diseases, China National Clinical Research Center for Neurological Diseases, the Chinese Stroke Association, National Center for Chronic and Non-communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations. Stroke Vasc Neurol. 2020 Sep;5(3):211-239. doi: 10.1136/svn-2020-000457. Epub 2020 Aug 21.

    PubMed 32826385

  • Brenton JN, Lehner-Gulotta D, Woolbright E, Banwell B, Bergqvist AGC, Chen S, Coleman R, Conaway M, Goldman MD. Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits. J Neurol Neurosurg Psychiatry. 2022 Jun;93(6):637-644. doi: 10.1136/jnnp-2022-329074. Epub 2022 Apr 13.

    PubMed 35418509

  • FOOD Trial Collaboration. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial. Stroke. 2003 Jun;34(6):1450-6. doi: 10.1161/01.STR.0000074037.49197.8C. Epub 2003 May 15.

    PubMed 12750536

  • Mehta A, De Paola L, Pana TA, Carter B, Soiza RL, Kafri MW, Potter JF, Mamas MA, Myint PK. The relationship between nutritional status at the time of stroke on adverse outcomes: a systematic review and meta-analysis of prospective cohort studies. Nutr Rev. 2022 Nov 7;80(12):2275-2287. doi: 10.1093/nutrit/nuac034.

    PubMed 35640017

Questions about this trial

What is this clinical trial studying?

An observational study of Neurological Disorder, run by Xuanwu Hospital, Beijing.

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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gaoting Ma, PhD (18301579891, demo_doctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06510712, which also lists 5 linked publications.

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 19 Jul 2024.

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