Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients

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 Overview

• Status: Completed
• Conditions: Peritoneal Dialysis; Resting Energy Expenditure; Equation

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Haidian Hospital
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center

Description

Inclusion Criteria:

• Peritoneal dialysis patients and hemodialysis patients
• Dialysis length >3 months
• >18 years old
• Consented to participate in all aspects of the study

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Novel equation development	Developed equation for estimating resting energy expenditure in peritoneal dialysis patients	March 18, 2021 to October 30, 2021
Novel equation validation	Validate the novel equation with resting energy expenditure obtained by indirect calorimetry (IC).	October 30, 2021 to December 30, 2021

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

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

• Other Study ID Numbers: REE equation in dialysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No