Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy

NCT ID: NCT03302546

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2022-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Incremental Hemodialysis

Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.

Group Type: ACTIVE_COMPARATOR

Incremental hemodialysis

Intervention Type: PROCEDURE

Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week

Conventional hemodialysis

Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.

Group Type: ACTIVE_COMPARATOR

Conventional hemodialysis

Intervention Type: PROCEDURE

Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week

Interventions

Incremental hemodialysis

Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects starting renal replacement therapy from January 2017 to June 2018.
• Subjects who consent to sign the Informed Consent Form.
• Subject who maintain residual diuresis and urea clearance equal or superior to 2,5 ml/min.

Exclusion Criteria

• Anuric patients.
• Patients with acute renal failure.
• Patients who revoke the Informed Consent Form.
• Patients who start hemodialysis after having going through a renal transplant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Ramón y Cajal

Madrid, , Spain

Countries

Spain

References

Fernandez Lucas M, Ruiz-Roso G, Merino JL, Sanchez R, Bouarich H, Herrero JA, Muriel A, Zamora J, Collado A. Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial. Trials. 2020 Feb 19;21(1):206. doi: 10.1186/s13063-020-4058-0.

Reference Type: DERIVED

PMID: 32075665 (View on PubMed)

Other Identifiers

034/17

Identifier Type: -

Identifier Source: org_study_id