The Relationship Between the Change of Resting Energy Expenditure and Nutritional Status .

Nutrition Clinical Trial

Official title:

The Relationship Between the Change of Resting Energy Expenditure(REE) and Nutritional Status in Peritoneal Dialysis(PD) Patients With Peritonitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511950
• Other study ID #: REE and peritonitis
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2022
• Source: Peking University First Hospital
• Contact: Jie Dong
• Phone: 13911841538
• Email: jie.dong[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Receiving PD for>3 months

• Age between 18 and 80 years

• Confirm diagnosis of peritonitis

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Nutrition
• Peritonitis
• Resting Energy Expenditure

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between the change of REE and the outcome of patients	outcome including death and transfer to hemodialysis	90 days or 180days
Primary	The relationship between the change of REE and the change of albumin	Method: REE, indirect calorimetry	90 days
Secondary	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	90 days
Secondary	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	90 days
Secondary	The relationship between the change of REE and the change of Fat mass	Method: REE, indirect calorimetry; Fat mass, Bioelectrical impedance	90 days
Secondary	The relationship between the change of REE and the change of lean body mass	Method: REE, indirect calorimetry; lean body mass, Bioelectrical impedance	90 days