The Relationship Between the Change of Resting Energy Expenditure and Nutritional Status .
1 other identifier
observational
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Apr 2021
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedSeptember 29, 2022
September 1, 2022
2.4 years
April 1, 2018
September 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The relationship between the change of REE and the change of albumin
Method: REE, indirect calorimetry
90 days
Secondary Outcomes (4)
The relationship between the change of REE and the change of BMI
90 days
The relationship between the change of REE and the change of handgrip strength
90 days
The relationship between the change of REE and the change of Fat mass
90 days
The relationship between the change of REE and the change of lean body mass
90 days
Other Outcomes (1)
The relationship between the change of REE and the outcome of patients
90 days or 180days
Eligibility Criteria
PD patients with confirm diagnosis of peritonitis
You may qualify if:
- Receiving PD for\>3 months
- Age between 18 and 80 years
- Confirm diagnosis of peritonitis
You may not qualify if:
- 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
- History of hormonal drugs use
- During pregnancy or lactation
- Mental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor in Renal Division, Department of Medicine
Study Record Dates
First Submitted
April 1, 2018
First Posted
April 30, 2018
Study Start
April 1, 2021
Primary Completion
August 30, 2023
Study Completion
October 30, 2023
Last Updated
September 29, 2022
Record last verified: 2022-09