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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03377413
Other study ID # REE equation
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2017
Est. completion date February 1, 2020

Study information

Verified date October 2020
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date February 1, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- CKD 3-5 stages

- Age:18-80 years old

Exclusion Criteria:

- Dialysis and kidney transplantation;

- 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 drugs use;

- During pregnancy or lactation

Study Design


Locations

Country Name City State
China Renal Division and Institute of Nephrology, 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 REE in CKD 3-5 stages patients September 1, 2017 to June 1, 2018
Primary Novel equation validation Validate the noval equation with REE obtained by indirect calorimetry (IC). June 1, 2018 to March 1, 2019
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