Outcome and Risk Factors For Mortality in Peritoneal Dialysis Patients: 20 Years Experience in a Single Turkish Center

October 21, 2016 updated by: Yasar Caliskan, Istanbul University

INTRODUCTION AND AIMS: The aims of this study were to evaluate patient and technique survival rates, investigate peritonitis rates and evaluate factors affecting mortality in peritoneal dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine Peritoneal Dialysis Unit.

METHODS: Two hundred seventy seven patients have received PD as renal replacement therapy (RRT) over a period of 20 years. After exclusion of patients with follow-up shorter than 3 months and patients whose data were not available, 250 patients were examined retrospectively. Data for sex, age, primary disease, comorbidities, follow up duration, cause of death, and cause of technique failure were collected from medical records.

Study Overview

Detailed Description

Material and Method All patients 18 years of age and older who were treated with PD at the Istanbul Medical Faculty from October 1994 to October 2014 were included in the study. Patients exclude which follow-up shorter than 3 months and patients whose data were not available. From the day PD was started, all peritonitis data were collected prospectively in a large database. The data include Socio-demographic data, type of peritoneal dialysis, starting time and duration of every peritonitis episode, causative organisms and outcome of the peritonitis, which could be cure, change of PD catheter, transfer to hemodialysis, or death. The time in months from PD start to the first episode of peritonitis was computed.

Primary kidney disease was classified into 9 main categories according to the codes of the European Renal Association - European Dialysis and Transplant Association. Peritonitis in PD was defined as a peritoneal dialysate effluent containing >100 white blood cells/mL, of which >50% were polymorphonuclear leukocytes. Patients with two or more pathogens isolated from the cultures in a peritonitis episode were considered to have polymicrobial peritonitis. A relapse of peritonitis was defined when the same organism or a culture-negative peritonitis episode was identified within 4 weeks of completing appropriate antibiotic therapy for a previous episode.

Socio-demographic, clinical and treatment characteristics, medium (standard deviation for continuous variables) or median (25th and 75th percentages); number for categorical variables (rate) were calculated. Cox regression analysis applied to examine the impact of demographic and clinical features of periton dialysis patients . Chi-square test for categorical variables used. Univariate and multivariate analyzes calculated using the Kruskal-Wallis or Mann-Whitney test method. P-value was <0.05 for as long as it is considered statistically significant. The evaluation of the results obtained using SPSS 21.0 software.

Study Type

Observational

Enrollment (Actual)

277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Two hundred seventy seven patients have received PD as renal replacement therapy (RRT) over a period of 20 years.

Description

Inclusion Criteria:

  • all patients 18 years of age and older
  • treated with PD at the Istanbul Medical Faculty from October 1994 to October 2014

Exclusion Criteria:

  • follow-up shorter than 3 months and patients whose data were not available,
  • data were not available
  • patients who were unwilling
  • patients who unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Who have received PD as renal replacement therapy (RRT) over a period of 20 years.
The aims of this study were to evaluate patient and technique survival rates, investigate peritonitis rates and evaluate factors affecting mortality in peritoneal dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine Peritoneal Dialysis Unit.
Other Names:
  • OUTCOME AND RISK FACTORS FOR MORTALITY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient survival
Time Frame: 5 - 10 years
5 - 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure
Time Frame: 5 - 10 years
Re-initiation of hemodialysis
5 - 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yasar Caliskan, Dr., Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1995

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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