NCT04947839

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

June 24, 2021

Last Update Submit

September 27, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking Haidian Hospital

Beijing, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor in Renal Division,Department of Medicine

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

March 18, 2021

Primary Completion

June 28, 2022

Study Completion

July 8, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations