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Kidney Week

Abstract: INFO26

Twice Against Thrice-Weekly Hemodialysis: the TATH Trial

Session Information

  • Informational Posters
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Aoun, Mabel Habib, Saint-Georges Hospital Ajaltoun, Beirut, Lebanon
  • Finianos, Serge S., Hotel-Dieu de France Hospital, Beyrouth, Lebanon
  • Alam eddine, Rachad, Orange Nasso Hospital, Tripoli, Lebanon
  • Azar, Hiba, Saint-Joseph University, Beirut, Lebanon
  • Sleilaty, Ghassan, Saint-Joseph University, Beirut, Lebanon
  • El boueri, Celine, Saint-Georges Hospital Ajaltoun , Beirut, Lebanon
  • Beaini, Chadia H., Bellevue Medical Center, Mansourieh, Lebanon
  • Chelala, Dania, Saint-Joseph University, Beirut, Lebanon
Description

In developing countries, twice-weekly hemodialysis independent of residual kidney function is still accepted because of lack of resources or patients’ resistance to undergo 3 sessions.
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 2 arms b) to compare the number of hospitalizations and duration of stay, c) to compare the rate of uncontrolled severe hypertension between the 2 groups, d) to analyze the quantity of ESA in units to achieve a Hb 11 to 11.5 g/dl.
This is a non-randomized, multicenter, clinical trial. Randomization was considered contradictory with the current international guidelines. Thus patient’s allocation was left at the nephrologist and patient’s agreement.
Inclusion criteria: all incident patients > 18 years started on chronic hemodialysis.
Exclusion criteria: terminally ill patients.
Patients will be assigned to 1 of 2 groups: Group 1 will receive three sessions of hemodialysis weekly. Group 2 will receive two sessions weekly.
Primary endpoint: All-cause mortality at 2 years
Secondary endpoints: -Rate of supplementary sessions for pulmonary edema or hyperkalemia
-Number of hospitalizations, duration of stay
-Severe hypertension
-ESA dose
Recruitment of patients will go on until the sample size is reached.
The total sample size needed is 806 patients. Assuming an attrition rate of 10%, we would need 896 patients.
Data collection: eCRF (electronic case report form) will be used for data capture.
Data for demographics, comorbidities, laboratory results, medications and dialysis prescription will be collected from the patients' medical records at dialysis initiation.
Statistical analysis: P-value of ≤0.05 considered statistically significant.
Follow-up will be done at 1, 3 and 6, 12 months and will include labs, medications, blood pressure, interdialytic fluid gain, hospitalizations, residual diuresis, death.
The study was approved by the ethics committee of Saint-Joseph University HDF 1114, in agreement with the Helsinki Declaration of 1975. Patients will give their written informed consent.
The trial is registered on ClinicalTrials.gov NCT03415776.