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

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ClinicalTrials.gov Identifier: NCT02922270
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Yasar Caliskan, Istanbul University

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.


Condition or disease Intervention/treatment
Therapeutic Procedural Complication Other: Peritoneal dialysis patients at the Istanbul Medical Faculty

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.

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Study Type : Observational
Actual Enrollment : 277 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Outcome and Risk Factors For Mortality in Peritoneal Dialysis Patients: 20 Years Experience in a Single Turkish Center
Study Start Date : October 1995
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
Patients
Who have received PD as renal replacement therapy (RRT) over a period of 20 years.
Other: 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.
Other Name: OUTCOME AND RISK FACTORS FOR MORTALITY




Primary Outcome Measures :
  1. Patient survival [ Time Frame: 5 - 10 years ]

Secondary Outcome Measures :
  1. Treatment failure [ Time Frame: 5 - 10 years ]
    Re-initiation of hemodialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922270


Sponsors and Collaborators
Istanbul University
Investigators
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Study Chair: Yasar Caliskan, Dr. Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

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Responsible Party: Yasar Caliskan, Director, Istanbul University
ClinicalTrials.gov Identifier: NCT02922270    
Other Study ID Numbers: 252
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yasar Caliskan, Istanbul University:
peritoneal dialysis: outcome
peritoneal dialysis: complications
peritoneal dialysis: technique
peritoneal dialysis: peritonitis