Resting Energy ExpenditureNCT04947839
Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients
An observational study of Resting Energy Expenditure and Peritoneal Dialysis, run by Peking University First Hospital at 2 sites in China.
Trial summary
The energy and nutrition states are closely associated with dialysis patients' complications and outcomes. To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resting Energy Expenditure, Peritoneal Dialysis, Equation
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 18 Mar 2021to 8 Jul 2022
- 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: All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center
Who may be able to join
- Peritoneal dialysis patients and hemodialysis patients
- Dialysis length >3 months
- >18 years old
- Consented to participate in all aspects of the study
Who cannot join
- 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 drug use;
- During pregnancy or lactation;
- Can not maintain posture and complete the REE test.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking Haidian Hospital
Beijing
About this study
The energy and nutrition states are closely associated with dialysis patients' complications and outcomes. To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations do not focus on and applicable to peritoneal dialysis patients, so we aim to develop and validate an equation for estimating resting energy expenditure in peritoneal patients.
- Conditions
- Resting Energy Expenditure, Peritoneal Dialysis, Equation
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel equation development
Developed equation for estimating resting energy expenditure in peritoneal dialysis patients
Measured: March 18, 2021 to October 30, 2021
Novel equation validation
Validate the novel equation with resting energy expenditure obtained by indirect calorimetry (IC).
Measured: October 30, 2021 to December 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start18 Mar 2021
- Primary completion28 Jun 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resting Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947839
- Sponsor's protocol ID
- REE equation in dialysis
- Status last verified
- Sep 2022
- First submitted
- 24 Jun 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients
- ClinicalTrials.gov ID
- NCT04947839
- Acronym / sponsor ID
- REE equation in dialysis
- Conditions
- Resting Energy Expenditure, Peritoneal Dialysis, Equation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 1 Jul 2021 (actual)
- 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 energy and nutrition states are closely associated with dialysis patients' complications and outcomes. To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations do not focus on and applicable to peritoneal dialysis patients, so we aim to develop and validate an equation for estimating resting energy expenditure in peritoneal patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center
Key inclusion criteria (4 listed)
- Peritoneal dialysis patients and hemodialysis patients
- Dialysis length >3 months
- >18 years old
- Consented to participate in all aspects of the study
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Novel equation development
Time frame: March 18, 2021 to October 30, 2021
Developed equation for estimating resting energy expenditure in peritoneal dialysis patients
Novel equation validation
Time frame: October 30, 2021 to December 30, 2021
Validate the novel equation with resting energy expenditure obtained by indirect calorimetry (IC).
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 29 Sep 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resting Energy Expenditure and Peritoneal Dialysis, run by Peking University First Hospital at 2 sites 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 8 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Novel equation development (time frame: March 18, 2021 to October 30, 2021). 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 29 Sep 2022.