- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03377413
Novel Equation for Estimating Resting Energy Expenditure
October 13, 2020 updated by: Dong Jie, Peking University First Hospital
Novel Equation for Estimating Resting Energy(REE) Expenditure in Chronic Kidney Disease(CKD) 3-5 Stages Patients
The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients.
Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100034
- Renal Division and Institute of Nephrology, Peking University First Hospital
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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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
chronic kidney disease 3-5 stages
Description
Inclusion Criteria:
- CKD 3-5 stages
- Age:18-80 years old
Exclusion Criteria:
- Dialysis and kidney transplantation;
- Acute complications to hospitalization
- 1 month prior to the study;
- Acute or chronic infections, cancer and other wasting diseases in the past year;
- Thyroid dysfunction;
- Acute onset of podagra; Musculoskeletal diseases;
- Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
- History of hormonal drugs use;
- During pregnancy or lactation
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Novel equation development
Time Frame: September 1, 2017 to June 1, 2018
|
Developed equation for estimating REE in CKD 3-5 stages patients
|
September 1, 2017 to June 1, 2018
|
Novel equation validation
Time Frame: June 1, 2018 to March 1, 2019
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Validate the noval equation with REE obtained by indirect calorimetry (IC).
|
June 1, 2018 to March 1, 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jie Dong, Renal Division and Institute of Nephrology, Peking University First Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
December 14, 2017
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
December 14, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 13, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REE equation
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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