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Albumin levels, inflammation and nutrition in chronic hemodialysis patients treated with medium cut-off or high-flux membranes: A cohort study

Albumin levels, inflammation and nutrition in chronic hemodialysis patients treated with medium cut-off or high-flux membranes: A cohort study

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN25749326
Enrollment
1224
Registered
2025-03-06
Start date
2017-09-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Urological and Genital Diseases

Interventions

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 prescripti

Sponsors

Baxter International, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1.Albumin serum (bromocresol green) was measured each six month ( baseline, 6,12,18,24,30,36,42,48 months) 2.Protein-energy wasting (PEW) was measured by applying the four diagnostic criteria: 2.1. altered serum biochemistry indicated by a serum albumin level of <3.8 g/L or total cholesterol <100 mg/dL 2.2. decreased body mass status identified by a body mass index (BMI) of <23 kg/m² or <10% total body fat 2.3. muscle wasting defined by the lean tissue index 2.4. low dietary protein intake determined by the normalized protein equivalent of a total nitrogen appearance of <0.8 g/kg/day. ( baseline, 6,12,18,24,30,36,42,48 months) 3.Hospitalization: defined as any hospital admission event lasting 24 hours or more. Recording the main diagnosis with ICD 10 code nomenclatura. Chronological record from day 1 to month 48 of follow-up. 4.Mortality: Death during follow-up in the study. Recording the diagnosis cause with ICD 10 code nomenclatura. Chronological record from day 1 to month 48 of follow-up. 5.Fatal major cardiovascular evento: Recording the diagnosis cause with ICD 10 code nomenclatura. Chronological record from day 1 to month 48 of follow-up. See Appendix 3 of the protocol.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Colombia

Contacts

Public ContactJuan Carlos Mario Castillo
juan.castillo@vantive.com+57 3204867219

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026