Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
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|ClinicalTrials.gov Identifier: NCT03302546|
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : February 15, 2019
The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a program of incremental hemodialysis, starting with two sessions a week in patients with residual renal function.
The main objective is to compare whether the initiation of hemodialysis with two sessions a week over conventional pattern of initiation of three sessions a week better preserves residual renal function.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Failure||Procedure: Incremental hemodialysis Procedure: Conventional hemodialysis||Not Applicable|
The primary specific objective is to assess the loss of renal function defined as 24 hours diuresis less than 100 ml at 12 months of starting treatment. Secondary objectives are: erythropoietin dose, concentration of beta 2-microglobulin, p-cresol, fenol, the state of hydration and nutrition, adverse effects, hospital admissions, mortality and quality of life, comparing both arms of treatment.
DESIGN: Multicenter randomized clinical trial. Randomization will be performed by an external agent that guarantees an homogeneous balance between both arms. The randomization sequence will not be available for the investigators responsible of the patients.
Inclusion criteria: Patients starting hemodialysis that maintain residual diuresis and urea clearance greater than or equal to 2.5 ml / min with a minimum follow-up of one year.
Exclusion criteria: Anuric patients, patients with acute renal failure and patients who start hemodialysis after having going through a renal transplant.
The variables that will be analyzed are 24h diuresis, urea clearance, creatinin clearance, haemoglobin, leukocytes, platelets, creatinin, urea, Na, K, albumin, prealbumin, Ca, P, PTH, PCR, ferritin, B2microglobulin, BNP, KT/V, Erythropoietin dose, state of hydratation and life quality.
Sample size should be of 42 patients on each arm of treatment to obtain a 95% confidence (α=0,05) and a 80% of statistical power (β=0,20).
The normality of the data will be analyzed with Kolmogorov-Smirnov test which will allow to use parametric tests (T-student) or non-parametric tests (U-Mann-Whitney). Association of categoric variables of both arms will be analyzed with Chi2 test, or using Fisher statistic.
Loss of renal function will be analyzed up to 12 months and time studies will be performed through non-parametric test (Kaplan-Meier), obtaining the estimated probability of loss of renal function in both arms and comparing survival functions through "Log-Rank" statistic.
The demonstration of efficacy and safety through a clinical trial would spread this clinical practice in the nephrology community and therefore in our national health system.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy|
|Actual Study Start Date :||April 4, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Active Comparator: Incremental Hemodialysis
Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.
Procedure: Incremental hemodialysis
Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week
Active Comparator: Conventional hemodialysis
Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.
Procedure: Conventional hemodialysis
Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week
- Asses the loss of residual renal function in patients who started chronic hemodialysis [ Time Frame: Measurements of multiple variables to measure renal function each two months during one year period ]Assess the loss of renal function evolution in patients starting hemodialysis therapy 2 days per week, versus patients with hemodialysis 3 days per week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302546
|Contact: Milagros Fernández-Lucas, MDemail@example.com|
|Contact: Andrea Collado, PhDfirstname.lastname@example.org|
|Hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: Milagros Fernández-Lucas, MD 913368810 email@example.com|
|Contact: Andrea Collado, PhD 913368018 firstname.lastname@example.org|
|Principal Investigator: Milagros Fernández-Lucas, MD|
|Sub-Investigator: Gloria Ruiz-Roso, MD|