Therapeutic Procedural ComplicationNCT02922270
Outcome and Risk Factors For Mortality in Peritoneal Dialysis Patients: 20 Years Experience in a Single Turkish Center
An observational study of Therapeutic Procedural Complication, run by Istanbul University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- Peritoneal dialysis patients at the Istanbul Medical Faculty
- How many people
- 277 participants
- Where
- No sites listed yet
- Study dates
- Oct 1995to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two hundred seventy seven patients have received PD as renal replacement therapy (RRT) over a period of 20 years.
Who may be able to join
- all patients 18 years of age and older
- treated with PD at the Istanbul Medical Faculty from October 1994 to October 2014
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- Peritoneal dialysis patients at the Istanbul Medical Faculty
- Keywords
- peritoneal dialysis: outcome, peritoneal dialysis: complications, peritoneal dialysis: technique, peritoneal dialysis: peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysis patients at the Istanbul Medical FacultyOther
Also called OUTCOME AND RISK FACTORS FOR MORTALITY
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Who have received PD as renal replacement therapy (RRT) over a period of 20 years. Receives: Other: Peritoneal dialysis patients at the Istanbul Medical Faculty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Measured: 5 - 10 years
Secondary outcomes (1)
Treatment failure
Re-initiation of hemodialysis
Measured: 5 - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 1995
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Procedural ComplicationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, Dr., Study chair, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922270
- Sponsor's protocol ID
- 252
- Status last verified
- Oct 2016
- First submitted
- 19 Sep 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Risk Factors For Mortality in Peritoneal Dialysis Patients: 20 Years Experience in a Single Turkish Center
- ClinicalTrials.gov ID
- NCT02922270
- Acronym / sponsor ID
- 252
- Conditions
- Therapeutic Procedural Complication
- Keywords
- peritoneal dialysis: outcome, peritoneal dialysis: complications, peritoneal dialysis: technique, peritoneal dialysis: peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Oct 1995
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Peritoneal dialysis patients at the Istanbul Medical FacultyWho have received PD as renal replacement therapy (RRT) over a period of 20 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred seventy seven patients have received PD as renal replacement therapy (RRT) over a period of 20 years.
Key inclusion criteria (2 listed)
- all patients 18 years of age and older
- treated with PD at the Istanbul Medical Faculty from October 1994 to October 2014
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal dialysis patients at the Istanbul Medical FacultyAlso: OUTCOME AND RISK FACTORS FOR MORTALITYThe 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 | Patients |
Primary outcome
Patient survival
Time frame: 5 - 10 years
1 secondary outcome
Treatment failure
Time frame: 5 - 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasar Caliskan, Dr. study chair
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Procedural Complication, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: 5 - 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.