Nutritional Management in Respiratory Critically Ill Patients -an Observational Study in Mainland China (NM-in-RCIP)

July 1, 2021 updated by: Qingyuan Zhan, China-Japan Friendship Hospital
The important role of nutritional management in the treatment of ICU patients has been paid more and more attention. Reasonable nutritional management can improve the nutritional status of patients, reduce the risk of malnutrition, shorten the length of ICU stay, improve the quality of life of patients, and reduce the mortality of patients, thereby improving the prognosis. Many studies have investigated the nutritional status and implementation of ICU patients. It is generally believed that the nutritional status of ICU patients is not good, and the implementation of standardization needs to be improved.The data on the nutritional status and implementation of RICU patients in mainland China is rare. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in mainland China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Respiratory critically ill patients have their own disease metabolism and treatment methods. However, RICU medical staff generally do not pay enough attention to nutrition support treatment. The data on the nutritional status and implementation of RICU patients in China is rare. But the data plays an important role in carrying out nutrition-related research, formulating the goals of continuing education programs for nutrition support treatment, guiding the introduction of medical insurance policies and the revision of consensus. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in tertiary hospitals in mainland China, so as to lay the foundation for further relevant work.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100028
        • Recruiting
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients admitted to RICU

Description

Inclusion Criteria:

  • patients aged >18 years
  • the length of RICU stays >48 hours

Exclusion Criteria:

  • patients aged ≤18 years
  • the length of RICU stays ≤48 hours
  • patients who were admitted to RICU due to or combined with severe trauma or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of enteral nutrition starting within 48 hours after ICU entry
Time Frame: 48 hours
Proportion of enteral nutrition starting within 48 hours after ICU entry
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional status and risk of malnutrition on ICU admission
Time Frame: 48 hours
To assess nutritional status and risk of malnutrition on ICU admission by NRS-2002 risk score and NUTRIC score
48 hours
The proportion of subjects receiving>80% estimated energy target within 7 days after ICU entry
Time Frame: 7 days
The proportion of subjects receiving>80% estimated energy target within 7 days after ICU entry
7 days
The proportion of enteral nutrition intolerance
Time Frame: 48 hours
The proportion of enteral nutrition intolerance
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China-Japan Friendship Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xijing Hospital
Changhai Hospital
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Nanchang University
Xiangya Hospital of Central South University
Wuhan University
Peking University People's Hospital
Fudan University
Beijing 302 Hospital
The Second Hospital of Hebei Medical University
Peking University Third Hospital
First Affiliated Hospital, Sun Yat-Sen University
Huashan Hospital
Tongji Hospital
First Affiliated Hospital Xi'an Jiaotong University
Peking University Shougang Hospital
Peking University International Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Ruijin Hospital
Beijing Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital of Zhengzhou University
The Third Xiangya Hospital of Central South University
Shaanxi Provincial People's Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Xinqiao Hospital of Chongqing
The First Affiliated Hospital of Kunming Medical College
First Hospital of China Medical University
Second Affiliated Hospital of Soochow University
Tianjin Medical University Second Hospital
First Affiliated Hospital of Wenzhou Medical University
Second Xiangya Hospital of Central South University
First Hospital of Shijiazhuang City
Cangzhou Central Hospital
First Affiliated Hospital Bengbu Medical College
Sichuan Provincial People's Hospital
Second Affiliated Hospital of Nanchang University
China Rehabilitation Research Center
Second Hospital of Jilin University
Qingdao Central Hospital
The First Affiliated Hospital of Dalian Medical University
The First People's Hospital of Lianyungang
The Second Hospital of Anhui Medical University
Subei People's Hospital of Jiangsu Province
Yantai Yuhuangding Hospital
Wuxi People's Hospital
Tianjin Chest Hospital
Wuhan Central Hospital
The Affiliated Zhongshan Hospital of Dalian University
Meizhou People's Hospital
Suzhou Municipal Hospital
The First People's Hospital of Changzhou
Hainan People's Hospital
The First People's Hospital of Yunnan
Jiangxi Provincial People's Hopital
The Fourth Affiliated Hospital of China Medical University
Taian City Central Hospital
The General Hospital of Eastern Theater Command
Dongfang Hospital Affiliated to Tongji University
Affiliated Hospital of Chengde Medical University
The First Affiliated Hospital of Hebei North University
Cangzhou People's Hospital
Dezhou People's Hospital
General Hospital of Tianjin Medical University
Dalian Municipal Central Hospital
Beijing Fangshan District Liangxiang Hospital
Jingzhou Central Hospital
The 306 Hospital of People's Liberation Army
Suzhou Hospital of Traditional Chinese Medicine
The Second Affiliated Hospital of Air Force Military Medical University
Heze Municipal Hospital
Zibo First Hospital
The General Hospital of Northern Theater Command
Beijing Jingmei Group General Hospital
The Affiliated Jiangning Hospital of Nanjing Medical University
Longyan First Affiliated Hospital of Fujian Medical University
Beijing Coal Group General Hospital
Beijing Rehabilitation Hospital, Capital Medical University
Huan'an First People's Hospital
Hebei Sheng Xiong Ke Yi Yuan
Affiliated Hospital of North China University of Science and Technology
Tangshan Central Hospital
Zhuozhou Hospital
Affiliated Central Hospital of Shenyang Medical College
Special Medical Center of the Armed Police Force
The Second People Hospital of Wuhu
The General Hospital of Southern Theater Command
Huai an First People Hospital
Nanjing No.1 Hospital
The First Affiliated Hospital of Xi an Medical University
No.2 People Hospital of Fuyang City
Central Command General Hospital
Taikang Xianlin Drum Tower Hospital
The First People Hospital of Nantong City
People Hospital of Dali Bai Autonomous Prefecture
The Sixth Central Hospital of PLA
The Third People Hospital of Datong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CJFH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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