Twice Against Thrice-weekly Hemodialysis

NCT03415776 | Terminated

• 1 other identifier: TATH2018
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis is the most worldwide prescribed renal replacement therapy for patients with end-stage renal disease. The frequency of sessions per week remains a debatable issue. In the majority of developed Western and Asian countries, patients on chronic hemodialysis are undergoing three dialysis sessions weekly. In developing countries and some developed countries, a twice-weekly schedule independent of residual kidney function is still accepted, sometimes because of lack of resources and some other times because of patients' resistance to undergo three sessions per week. The primary objective of this trial is to assess the total mortality of patients on thrice against twice-weekly hemodialysis. The secondary objectives are a) to compare the rate of urgent supplementary hemodialysis sessions between the two arms, mainly those due to pulmonary edema and hyperkalemia, b) to compare the number of hospitalizations and duration of stay, c) to compare the rate of uncontrolled hypertension between the two groups, d) to analyze the quantity of erythropoiesis-stimulating agents (ESAs) in units to achieve a haemoglobin (Hb) 11 to 11.5 g/dl, e) to assess the factors associated with a higher mortality in the two groups.

Conditions

Hemodialysis Complication

Keywords

Hemodialysis; Sessions frequency; Mortality; Morbidity

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause mortality

  0-24 months

Secondary Outcomes (4)

• Supplementary dialysis sessions

  0-12 months

• Hospitalizations

  0-12 months

• Uncontrolled hypertension

  0-12 months

• ESA dose

  0-12 months

Study Arms (2)

Twice weekly

EXPERIMENTAL

Two sessions of hemodialysis per week

Procedure: Hemodialysis

Thrice weekly

EXPERIMENTAL

Three sessions of hemodialysis per week

Procedure: Hemodialysis

Interventions

Hemodialysis PROCEDURE

Renal replacement therapy

Thrice weekly; Twice weekly

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all incident patients 18 years and older with CKD stage 5 started on hemodialysis.

You may not qualify if:

• late-stage cancer patients and participants who are terminally ill defined as having an expected survival of less than 3 months.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Georges Hospital

Ajaltoun, Keserwan, Lebanon

Location

Related Publications (1)

• Aoun M, Finianos S, Beaini C, Sleilaty G, Ghaleb R, Nourie N, Kais S, Hajal JE, Alameddine R, Boueri C, Ghoul BE, Zeidan S, Azar H, Dfouni A, Hawi J, Mechref Z, Hage V, Chelala D. Twice against thrice-weekly hemodialysis (TATH): a multicenter nonrandomized trial. BMC Nephrol. 2025 Apr 5;26(1):176. doi: 10.1186/s12882-025-04105-3.

  PMID: 40188011 DERIVED

MeSH Terms

Interventions

Renal Dialysis

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Mabel Aoun, MD

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mabel Aoun. Head of the Department of Nephrology, Saint-Georges Hospital Ajaltoun

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 30, 2018
• Study Start: February 16, 2018
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

LE (1)