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IRCT20240511061739N1 IRCT 2024-06-05 Pak Emirates Military Hospital Effect of dialysis fluid temperature in haemodialysis Comparison of the effects of different dialysate temperatures on adequacy of haemodialysis in patients with end stage renal disease 2024-05-30 anticipated 50 Complete https://irct.ir/trial/76863 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization would be done using computer generating sequencing. This would be done using online tools (calculator.net website). This would then be concealed in opaque envelopes, Blinding description: Patients and their caregivers would be blinded to the dialysate temperature, since this is set by the dialysis technicians and the patients are not aware of these settings. This parameter would not be visible on the display panel of the machines during the haemodialysis sessions, and would thus remain concealed from the patients It would not be possible to blind the paramedical staff carrying out the dialysis sessions. However, they would have no role in data collection or analysis. Similarly, the principal investigator and two other doctors involved in data collection would not be blinded to the treatment groups. Since the outcome measures for this study are objective laboratory parameters, this lack of blinding is not expected to have a significant impact on the results. N/A End-stage Renal Disease. Intervention 1: Intervention group 1: Dialysate Temperature 37.0 degree Celsius. Patients in this group would have the dialysate temperature set at 37.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight. Intervention 2: Intervention group 2: Dialysate Temperature 36.0 degree Celsius. Patients in this group would have the dialysate temperature set at 36.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight. Yes - There is a plan to make this available What will be shared: When: To whom: Conditions: Where to obtain: How to obtain: Comments:
public Altaf Hussain
The Mall Road
Rawalpindi Pakistan 4600 +92 302 5757487 altafhussainafridi8@gmail.com Pak Emirates Military Hospital scientific Altaf Hussain
The Mall Road
Rawalpindi Pakistan 46000 +92 302 5757487 altafhussainafridi8@gmail.com Pak Emirates Military Hospital Pakistan Patients on maintenance haemodialysis for at least 3 months Use of arteriovenous fistula for haemodialysis 19 years no limit Both Acute kidney injury History of intradialytic hypotension during last one month Shortening of haemodialysis session for any reason Interruption in haemodialysis session for more than 5 minutes Patients known to have central venous stenosis Uncooperative patients Lack of consent N18.6 End stage renal disease Treatment - Other Treatment - Other Intervention group 1: Dialysate Temperature 37.0 degree Celsius. Patients in this group would have the dialysate temperature set at 37.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight. Intervention group 2: Dialysate Temperature 36.0 degree Celsius. Patients in this group would have the dialysate temperature set at 36.0 degree Celsius when the machine is being setup for a dialysis session. The same temperature of dialysate would be maintained throughout the session of 4 hours duration. Ultrafiltration would be done to the usual dry weight. Urea reduction ratio. Timepoint: At the start and end of haemodialysis session. Method of measurement: Laboratory testing for serum urea levels. Online Kt/V. Timepoint: During the four hours haemodialysis session. Method of measurement: Online Clearance Monitoring module of Fresenius F4008 machines. Pak Emirates Military Hospital Approved 2024-01-24 Ethics Committee, Pak Emirates Military Hospital The Mall Road Rawalpindi Punjab Pakistan