A retrospective comparison of two types of dialysis machine for dialysis patients
| ISRCTN | ISRCTN12403265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12403265 |
| Secondary identifying numbers | RCS2020-001 |
- Submission date
- 11/08/2020
- Registration date
- 13/08/2020
- Last edited
- 28/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Background and study aims
Dialysis is a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly. It often involves diverting blood to a machine to be cleaned.
Normally, the kidneys filter the blood, removing harmful waste products and excess fluid and turning these into urine to be passed out of the body.
The aim is to determine whether there are differences in the clinical outcomes of expanded hemodialysis (HDx) by Theranova® compared with conventional hemodialysis (HD) with high-flux dialysis machines in Colombia.
Who can participate?
Patients who underwent dialysis for at least 90 days between 01 September 2017 and 30 November 2017.
What does the study involve?
Review of patient records for outcomes at 2 years after dialysis.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Renal Therapy Services (Colombia)
When is the study starting and how long is it expected to run for?
May 2020 to December 2020
Who is funding the study?
Renal Therapy Services (Colombia)
Who is the main contact?
Prof. Mauricio Sanabria, mauricio_sanabria@baxter.com
Contact information
Prof Mauricio Sanabria
Scientific
Scientific
Carrera 7c bis # 141a -36
Bogota
110221002
Colombia
 ORCID ID |
0000-0002-5111-9832 |
|---|---|
| Phone | +57 3153663465 |
| mauricio_sanabria@baxter.com |
Study information
| Study design | Retrospective observational multicentre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available (retrospective study) |
| Scientific title | Effectiveness of expanded hemodialysis (HDx) in Colombia: A retrospective clinical outcomes study |
| Study acronym | COREXH-E |
| Study objectives | Expanded hemodialysis (HDx) could decrease frequency of hospitalization, hospital days and mortality compared with hemodialysis with high flux dialyzer. |
| Ethics approval(s) | Approved 06/05/2020, Fundación Cardioinfantil Ethics committee (Bogota street 163A #13B-60, Bogotá, Colombia; +57 16672727; eticainvestigacion@cardioinfantil.org), ref: 15-2020 |
| Health condition(s) or problem(s) studied | End stage renal disease (Hemodialysis patients) |
| Intervention | Patient Population: Prevalent HD patients will be entered into two cohorts and followed for 2 years Cohort 1: patients who receive treatment with HDx using Theranova dialyzers. These patients were enrolled in the original COREXH registry between 1st of September of 2017 until 30 of November of 2017. Cohort 2: patients from the same clinics and time frame as Cohort 1 who receive treatment via conventional HD using a high-flux dialyzer. Patients with a high comorbidity index who were not expected to survive 6 months according to clinic notes will be excluded from Cohort 2 to control for exclusion of patients (with a life expectancy of less than six months as determined by his/her attending physician) in Cohort 1 of the COREXH registry. Test and Observation Schedule: Patients in this study were either enrolled in COREXH registry study between 1 September and 30 November 2017 or received conventional High-Flux HD during the same time period. Cohort assignment will be determined according to whether the patient was prescribed with HDx during that period, or instead remained prescribed with high-Flux HD. After the enrollment date, each patient will be followed for two years, with the end date of follow-ups within the study on November 30, 2019. Statistical Methods: Variables will be analysed descriptively and summarized for all eligible patients with available data. Continuous variables will be summarized by sample size (N), mean, standard deviation, median, minimum, maximum and compared using t tests with p values. Frequency and percentages will be provided for categorical variables and compared using chi-square test with p values. Weighted samples (with IPTW) will be used for the cohort´s comparisons. For comparing hospitalization, mortality and non-fatal cardiovascular events between HDx and HF HD groups, Inverse probability of treatment weighting (IPTW) using the propensity score will be conducted according to the baseline variables that might indicate potential confounding within exposure and outcomes. The propensity score will be estimated using a multivariate logistic model in which the baseline variables (at the time of inclusion to the cohort) were predictors of the exposure status. After estimating the propensity score, the IPTW for each individual subject will be calculated, the balance of the baseline variables with standardized differences less than 0.1 will be evaluated. Incidence rates for each group will be estimated; survival functions will be calculated using Kaplan-Meier estimators; comparisons of survival functions will be performed. Additionally, statistical modelling will be performed on all patients to evaluate clinical outcomes. Hazard-Ratios (HRs) for comparing hazards between HDx and HF HD groups will be estimated using proportional hazards after adjusting for potential confounders.For variables related with count outcomes (e.g. days of hospitalization, number of phosphorus chelating agents, antihypertensive drugs and nutritional supplements), According to overdispersion assumption Poisson or negative binomial regression models will be used to estimate the strength of the association between type of dialysis and counts of events after adjusting for potential confounders. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | 1. Theranova dialyzer 2. Revaclear dialyzer 3. Polyflux dialyzer |
| Primary outcome measure | Measured using patient records at 2 year follow up: 1. Hospitalization events 2. Days spent in hospital |
| Secondary outcome measures | Measured using patient records at 2 year follow up: 1. Mortality 2. Medication consumption |
| Overall study start date | 06/05/2020 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,250 |
| Total final enrolment | 1098 |
| Key inclusion criteria | 1. End stage renal disease 2. Prevalent HD patient defined as having received HD for 90 days or more at the time of the cohort’s inception (01 September 2017 through 30 November 2017) 3. Enrolled in the COREXH registry between 01 September 2017 and 30 November 2017, or were treated via conventional high-flux HD during the same time period at the same renal centers, and with the same model of dialysis care 4. Undergoing HD at least 3 times per week and a minimum duration of 4 hours per session 5. Received dialysis treatment in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI) |
| Key exclusion criteria | 1. High comorbidity measured as Charlson comorbidity Index > 8 and patients who were not expected to survive 6 months 2. Metastatic disease 3. Pregnancy 4. Younger than 18 years old |
| Date of first enrolment | 01/08/2020 |
| Date of final enrolment | 15/09/2020 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Renal Therapy Services dialysis network Colombia
Transversal 23 N 97-73 floor 6
Bogota
110221002
Colombia
Bogota
110221002
Colombia
Sponsor information
Renal Therapy Services
Other
Other
Transversal 23 #97-73, floor 6
Bogota
110221002
Colombia
| Phone | +57 3202330486 |
|---|---|
| Fabiola_aldana@baxter.com |
Funders
Funder type
Hospital/treatment centre
Renal Therapy Services
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | "Planned publication in a high-impact peer-reviewed journal" and scientific presentation in international congress. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | medium cutoff (MCO) versus high-flux (HF) dialysis membranes results | 07/02/2022 | 23/02/2022 | Yes | No |
Editorial Notes
28/03/2022: Internal review.
24/02/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
13/08/2020: Trial’s existence confirmed by Fundacion Cardioinfantil
