NCT03798171

Brief Summary

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit. This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

January 7, 2019

Last Update Submit

January 7, 2019

Conditions

Peritoneal Dialysis Catheter Infection

Keywords

peritoneal dialysisexit siteinfectionperitonitis

Outcome Measures

Primary Outcomes (1)

  • exit-site infection rate

    number of exit-site infection during 3 years of follow up, compared to historical data

    36 months

Secondary Outcomes (1)

  • peritonitis rate

    36 months

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

peritoneal dialysis patients in Tel Aviv Sourasky medical center

You may qualify if:

  • peritoneal dialysis patients capable to sign an informed consent or have an official guardian

You may not qualify if:

  • patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Canter

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

InfectionsPeritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsPeritoneal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of nephrology

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

May 15, 2018

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

IL(1)