PeritonitisNCT03511950
The Relationship Between the Change of Resting Energy Expenditure and Nutritional Status .
An observational study of Peritonitis and Resting Energy Expenditure, run by Peking University First Hospital at 1 site in China.
Trial summary
Peritonitis is a common and devastating complication in patients on peritoneal dialysis (PD). It is a known fact that persistent inflammatory state and nutritional deterioration are closely associated with increased mortality in PD patients.And resting energy expenditure(REE) is significantly increased in acute and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritonitis, Resting Energy Expenditure, Nutrition
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients with confirm diagnosis of peritonitis
Who may be able to join
- Receiving PD for>3 months
- Age between 18 and 80 years
- Confirm diagnosis of peritonitis
Who cannot join
- Disability
- Other acute complications: including systemic infections except for peritonitis, acute cardia-cerebrovascular disease in one month
- Active hepatitis and musculoskeletal diseases in the past
- Cancer and is treated with chemoradiotherapy within 1 year
- Severe edema of the whole body or a large amount of body cavity effusion
- Thyroid dysfunction
Show all 9Show fewer
- History of hormonal drugs use
- During pregnancy or lactation
- Mental disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Jie Dong, 13911841538, jie.dong@bjmu.edu.cn
About this study
Official title: The Relationship Between the Change of Resting Energy Expenditure(REE) and Nutritional Status in Peritoneal Dialysis(PD) Patients With Peritonitis.
Peritonitis is a common and devastating complication in patients on peritoneal dialysis (PD). It is a known fact that persistent inflammatory state and nutritional deterioration are closely associated with increased mortality in PD patients.And resting energy expenditure(REE) is significantly increased in acute and chronic inflammation in patients with chronic kidney disease (including dialysis patients).However,it is limited to the changing trend and duration of REE in peritonitis.Investigators hypothesize that the increase in total energy consumption resulting from the increase of REE which may accompany with decreased energy intake will lead to negative energy balance and nutritional deterioration, which may affect the prognosis of patients.Therefore,a prospective cohort study will be designed to dynamically research the change of REE accompanied with the nutrition status in peritonitis and provide the basis for peritonitis management in the future.
- Conditions
- Peritonitis, Resting Energy Expenditure, Nutrition
- Medical subject headings
- Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between the change of REE and the change of albumin
Method: REE, indirect calorimetry
Measured: 90 days
Secondary outcomes (4)
The relationship between the change of REE and the change of BMI
The relationship between the change of REE and the change of BMI during 90 days after peritonitis
Measured: 90 days
The relationship between the change of REE and the change of handgrip strength
The relationship between the change of REE and the change of handgrip strength during 90 days after peritonitis
Measured: 90 days
The relationship between the change of REE and the change of Fat mass
Method: REE, indirect calorimetry; Fat mass, Bioelectrical impedance
Measured: 90 days
The relationship between the change of REE and the change of lean body mass
Method: REE, indirect calorimetry; lean body mass, Bioelectrical impedance
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Apr 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
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
- NCT03511950
- Sponsor's protocol ID
- REE and peritonitis
- Status last verified
- Sep 2022
- First submitted
- 1 Apr 2018
- 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
- The Relationship Between the Change of Resting Energy Expenditure(REE) and Nutritional Status in Peritoneal Dialysis(PD) Patients With Peritonitis.
- ClinicalTrials.gov ID
- NCT03511950
- Acronym / sponsor ID
- REE and peritonitis
- Conditions
- Peritonitis, Resting Energy Expenditure, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 30 Apr 2018 (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.
Peritonitis is a common and devastating complication in patients on peritoneal dialysis (PD). It is a known fact that persistent inflammatory state and nutritional deterioration are closely associated with increased mortality in PD patients.And resting energy expenditure(REE) is significantly increased in acute and chronic inflammation in patients with chronic kidney disease (including dialysis patients).However,it is limited to the changing trend and duration of REE in peritonitis.Investigators hypothesize that the increase in total energy consumption resulting from the increase of REE which may accompany with decreased energy intake will lead to negative energy balance and nutritional deterioration, which may affect the prognosis of patients.Therefore,a prospective cohort study will be designed to dynamically research the change of REE accompanied with the nutrition status in peritonitis and provide the basis for peritonitis management in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients with confirm diagnosis of peritonitis
Key inclusion criteria (3 listed)
- Receiving PD for>3 months
- Age between 18 and 80 years
- Confirm diagnosis of peritonitis
Key exclusion criteria (9 listed)
- Disability
- Other acute complications: including systemic infections except for peritonitis, acute cardia-cerebrovascular disease in one month
- Active hepatitis and musculoskeletal diseases in the past
- Cancer and is treated with chemoradiotherapy within 1 year
- Severe edema of the whole body or a large amount of body cavity effusion
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
The relationship between the change of REE and the change of albumin
Time frame: 90 days
Method: REE, indirect calorimetry
4 secondary outcomes
The relationship between the change of REE and the change of BMI
Time frame: 90 days
The relationship between the change of REE and the change of handgrip strength
Time frame: 90 days
The relationship between the change of REE and the change of Fat mass
Time frame: 90 days
The relationship between the change of REE and the change of lean body mass
Time frame: 90 days
Results and safety
Results are not available in the source record.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis and Resting Energy Expenditure, run by Peking University First 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 3 inclusion and 9 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Dong (13911841538, jie.dong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between the change of REE and the change of albumin (time frame: 90 days). 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.