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

September 27, 2022 updated by: Dong Jie, Peking University First Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:

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

PD patients with confirm diagnosis of peritonitis

Description

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

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
The relationship between the change of REE and the change of albumin
Time Frame: 90 days
Method: REE, indirect calorimetry
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 BMI during 90 days after peritonitis
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 handgrip strength during 90 days after peritonitis
90 days
The relationship between the change of REE and the change of Fat mass
Time Frame: 90 days
Method: REE, indirect calorimetry; Fat mass, Bioelectrical impedance
90 days
The relationship between the change of REE and the change of lean body mass
Time Frame: 90 days
Method: REE, indirect calorimetry; lean body mass, Bioelectrical impedance
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between the change of REE and the outcome of patients
Time Frame: 90 days or 180days
outcome including death and transfer to hemodialysis
90 days or 180days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

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)

April 1, 2021

Primary Completion (ANTICIPATED)

August 30, 2023

Study Completion (ANTICIPATED)

October 30, 2023

Study Registration Dates

First Submitted

April 1, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (ACTUAL)

April 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REE and peritonitis

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.

Clinical Trials on Peritonitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe