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

NCT ID: NCT02922270

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 277 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1995-10-31
• Study Completion Date: 2015-10-31

Brief Summary

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.

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.

Conditions

Therapeutic Procedural Complication

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients

Who have received PD as renal replacement therapy (RRT) over a period of 20 years.

Peritoneal dialysis patients at the Istanbul Medical Faculty

Intervention Type: OTHER

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.

Interventions

Peritoneal dialysis patients at the Istanbul Medical Faculty

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.

Intervention Type: OTHER

Other Intervention Names

OUTCOME AND RISK FACTORS FOR MORTALITY

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Yasar Caliskan

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasar Caliskan, Dr.

Role: STUDY_CHAIR

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

Other Identifiers

252

Identifier Type: -

Identifier Source: org_study_id