Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

September 30, 2019 updated by: Alexandre Minetto Brabo, Universidade Estadual Paulista Júlio de Mesquita Filho
This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned modalities in chronic kidney disease (CKD) patients is the reality in the practice for both hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the initiation of the modality in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the initiation of the method without a functional arteriovenous fistula, i.e., with a central venous catheter (nontunneled or tunneled).

Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to unplanned HD, with the similar rates of infection and survival.

On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when compared to HD, however the literature lacks in this kind of analysis in unplanned methods.

Briefly, the workgroup will follow patients that would anyway start a Renal Replacement Therapy by an unplanned method and register Government payment for the therapy, including the therapy direct costs and the costs with events (internation, infection), access for dialysis, laboratory and CKD specific medications to performed a cost-effectiveness analysis in both groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).

The workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.

The study is unicentric, the therapy is continuous and necessary for the maintenance of life; therefore, no great difficult in the follow up is expected. A database with up-to-date information of patients will be functional during the study.

A Markov model will be developed to assess the relative cost-effectiveness of different dialysis modality distribution scenarios versus current practice. The model considers a hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring dialysis and adopts payer perspective. Markov models have been used to model dialysis treatment in previous economic analyses and are widely accepted to be suitable for modelling chronic condition

Statistical analysis plan:

From the study protocol, the data will be entered in a spreadsheet and verified typographical errors and their analysis will be performed using the statistical program Statistical Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA, 2012).

Considering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8 and cost difference detection between groups of 15%, the calculated sample size for each group is 94 patients.

Initially descriptive analysis will be done for all patients treated in the period, calculated measures of central tendency and dispersion for continuous variables and frequencies for categorical variables.

For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized Linear Model (GENMOD) procedure will be used.

Chi Square will be used to compare categorical variable between the two groups. T test or Mann-Whitney will be used to compare parametric continue variables.

By the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be presented at the end of the study. A p-value of 5% or lower will be considered to be statistically significant

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18606-260
        • Hospital das Clínicas da Faculdade de Medicina de Botucatu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Incident dialysis patients.

Description

Inclusion Criteria:

  • Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.

Exclusion Criteria:

  • Transitions between HD and PD
  • Patients with functional arteriovenous fistula entering hemodialysis
  • Patients with functional PD access implanted ate least 48h before the first use
  • Patient or family trained in PD and/or with the right adequacy of the home

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Unplanned Peritoneal Dialysis
CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate peritoneal dialysis (PD) in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. The patient must not have any absolute contraindications to initiate PD, which include: presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2> 70%); abdominal infections; severe hyperkalemia with changes characteristic in ECG; and acute pulmonary edema. These patients will be treated with HD.
Unplanned Hemodialysis
CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate HD without a functional arteriovenous fistula, ie, with a central venous catheter (nontunneled or tunneled).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)
Time Frame: 12 months
Cost effectiveness analysis of unplanned PD and HD with the data collected at our center
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost effectiveness analysis of unplanned PD and HD in national and international scenario
Time Frame: 12 months
Transpose the cost-effectiveness analysis to a national and international scenario, using a Markov model
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 97/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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