NCT03511950

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 1, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

2.4 years

First QC Date

April 1, 2018

Last Update Submit

September 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The relationship between the change of REE and the change of albumin

    Method: REE, indirect calorimetry

    90 days

Secondary Outcomes (4)

  • The relationship between the change of REE and the change of BMI

    90 days

  • The relationship between the change of REE and the change of handgrip strength

    90 days

  • The relationship between the change of REE and the change of Fat mass

    90 days

  • The relationship between the change of REE and the change of lean body mass

    90 days

Other Outcomes (1)

  • The relationship between the change of REE and the outcome of patients

    90 days or 180days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients with confirm diagnosis of peritonitis

You may qualify if:

  • Receiving PD for\>3 months
  • Age between 18 and 80 years
  • Confirm diagnosis of peritonitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 30, 2018

Study Start

April 1, 2021

Primary Completion

August 30, 2023

Study Completion

October 30, 2023

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations