Albumin levels, inflammation and nutrition in chronic hemodialysis patients treated with medium cut-off or high-flux membranes: A cohort study
| ISRCTN | ISRCTN25749326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25749326 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RCS2022-002 |
| Sponsor | Baxter International, Inc. |
| Funder | Baxter International |
- Submission date
- 04/03/2025
- Registration date
- 06/03/2025
- Last edited
- 05/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This is an analytical, multicenter, retrospective cohort study whose main objective was to establish the role of serum albumin levels, as well as markers of inflammation and malnutrition on outcomes such as mortality, non-fatal cardiovascular events, hospitalization and hospital days in hemodialysis patients treated with medium cut-off (MCO) or high-flux membranes (HD AF).
Who can participate?
Adults , preceding HD treatment > 90 days, treatment either by HDx therapy enabled by Theranova membrane or conventional HD using an high flux membrane (HF-HD) for a minimum of 4 hours, 3 times per week. The exclusion criteria were life expectancy of less than 6 months, active infection, metastatic disease, or a Charlson comorbidity index score >8.
What does the study involve?
This is a retrospective cohort study compared to patients with the same characteristics treated with conventional HF HD versus HDx. The inception phase of the cohorts was between September 1, 2017 and November 30, 2017. After cohort assembly, demographic and clinical information on each patient will be collected longitudinally over time for up to a maximum of four (4) years.Censored events were a kidney transplant, loss of follow-up, suspension of dialysis therapy, change of dialysis provider, change of dialysis modality, change of type of membrane, and recovered kidney function.
What are the possible benefits and risks of participating?
The subjects' participation in this study did not entail any direct risks to their health, other than those already existing due to their health condition and their chronic hemodialysis program. The expected benefits for the patient are less inflammation, reduction of hospitalization events and reduction of non-fatal cardiovascular events and reduction in mortality.
Where is the study run from?
Renal Care Services-Latin America (Colombia)
When is the study starting and how long is it expected to run for?
September 2017 to November 2021
Who is funding the study?
Baxter International, Inc. (USA)
Who is the main contact?
Mauricio Sanabria, mauricio.sanabria@vantive.com
Contact information
Public, Scientific, Principal investigator
CR 7 No. 47-35
Soacha
250055
Colombia
| Phone | +57 3204867219 |
|---|---|
| juan.castillo@vantive.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational retrospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Albumin levels, inflammation and nutrition in chronic hemodialysis patients treated with medium cut-off or high-flux membranes: A cohort study |
| Study objectives | There is a difference when comparing HDx versus HF-HD in terms of albumin levels, hospitalizations, non-fatal cardiovascular events and mortality. |
| Ethics approval(s) |
Approved 31/05/2023, Cardio Foundation (calle 153 No 13B-60, Bogota, 1113111, Colombia; +57 6016672727; eticainvestigacion@lacardio.org), ref: IRB00007736 minute 019-2023 |
| Health condition(s) or problem(s) studied | Hemodialysis |
| Intervention | Patients were divided into two cohorts: HDx and HF-HD. The use of HDx, enabled by the Theranova dialyzer, was dependent on the availability of these membranes at the clinical sites, and the prescription of membranes was at the discretion of the treating nephrologist. Demographic and clinical characteristics were assessed at baseline and every six months for a maximum of 4 years, and all data were collected from the Renal Care Services' Versia® electronic medical record system. An internal audit was performed as part of a data quality assurance process. |
| Intervention type | Device |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Theranova dialyzer and high flux dialyzers |
| Primary outcome measure(s) |
1. Albumin serum (bromocresol green) was measured each six month ( baseline, 6,12,18,24,30,36,42,48 months) |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 94 Years |
| Sex | All |
| Target sample size at registration | 1224 |
| Total final enrolment | 1092 |
| Key inclusion criteria | 1. Patients over 18 years of age. 2. Patients diagnosed with chronic kidney disease (CKD) in renal failure with more than 90 days in chronic hemodialysis. 3. Receiving HD at least 3 times per week and with a minimum duration of 4 hours per session. 4. Being treated in one of the 12 renal clinics of the Baxter Renal Care Services (BRCS) network included in the study, in the cities of Bucaramanga, Barranquilla, Medellín, Bogotá, Ibague, Armenia, Cali. 5. Being covered by one of the following health insurers: Nueva EPS, Compensar, Comparta, Comfenalco Valle and Mutualser |
| Key exclusion criteria | 1. Pregnant women. 2. Patients whose clinical history does not have sufficient information to establish their nutritional diagnosis. 3. Having a high comorbidity, measured as a Charlson comorbidity index > 8 and patients who are not expected to survive more than 6 months. 4. Metastatic disease |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 30/11/2017 |
Locations
Countries of recruitment
- Colombia
Study participating centres
Bogota
110211
Colombia
Bogota
110211
Colombia
Barrio Sociego
Bogota
110211
Colombia
Bogota
110211
Colombia
Barranquilla
080003
Colombia
local SS10-A-B-C-D Centro Comercial el Cacique
Bucaramanga
680005
Colombia
Cali
760004
Colombia
Medellin
050011
Colombia
cali
760004
Colombia
Armenia
630004
Colombia
Ibague
730005
Colombia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Database for the study are available from the principal investigator (juan.castillo@vantive.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 28/02/2023 | 05/03/2025 | No | No | |
| Statistical Analysis Plan | version 1.0 | 28/02/2023 | 05/03/2025 | No | No |
Additional files
- 46940 Protocol 28Feb2023.pdf
- Protocol file
- 46940 SAP v1.0 28Feb2023.pdf
- Statistical Analysis Plan
Editorial Notes
04/03/2025: Trial's existence confirmed by Cardio Foundation.
