Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients

Peritoneal Dialysis Clinical Trial

Official title:

Novel Equation for Estimating Resting Energy Expenditure in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947839
• Other study ID #: REE equation in dialysis
• Status: Completed
• Start date: March 18, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: September 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 8, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritoneal Dialysis
• Resting Energy Expenditure

Locations

Country	Name	City	State
China	Peking Haidian Hospital	Beijing
China	Peking University First Hospital	Beijing	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
Primary	Novel equation development	Developed equation for estimating resting energy expenditure in peritoneal dialysis patients	March 18, 2021 to October 30, 2021
Primary	Novel equation validation	Validate the novel equation with resting energy expenditure obtained by indirect calorimetry (IC).	October 30, 2021 to December 30, 2021