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IRCT20241030063550N1 IRCT 2025-02-07 National University Of Medical Sciences Effect of Cooler Dialysate Temperature on Haemodynamic Stability in Hypotensive Patients on Maintenance Haemodialysis Effect of Cooler Dialysate Temperature on Haemodynamic Stability in Hypotensive Patients on Maintenance Haemodialysis 2024-09-01 anticipated 70 Complete https://irct.ir/trial/81745 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation in this study is achieved using a computer-generated randomization sequence, prepared by an independent statistician who is not involved in the trial's conduct. Participants are assigned to either the cooler dialysate (35.5°C) or standard dialysate (37°C) group in a 1:1 ratio, with allocation concealed using sealed, opaque envelopes. These envelopes are opened only after participant enrollment by an independent technician, who then programs the dialysis machines accordingly, ensuring that neither participants nor healthcare providers can influence or predict group assignment. This method ensures a robust and unbiased randomization process, Blinding description: This study is a double-blind randomized controlled trial investigating the effect of cooler dialysate temperature on hemodynamic stability in hypotensive patients undergoing maintenance hemodialysis. Both participants and healthcare providers, including physicians and nurses, are blinded to the dialysate temperature settings. The dialysis machines are pre-programmed by an independent technician, and the temperature display is concealed to prevent unblinding. Data collectors and outcome assessors are also blinded to group allocations, analyzing anonymized data without knowledge of the intervention. The principal investigator remains blinded during data collection and analysis to minimize bias. Additionally, the Data Safety and Monitoring Board (DSMB) reviews coded, anonymized data to ensure safety and efficacy without compromising blinding. This double-blind design ensures the integrity and reliability of the study outcomes. N/A Hypotension in Hemodialysis patients. Intervention 1: Intervention group: standard 4hrs hemodialysis with fresenius 4008 series hemodialysis machines, with standard flow rate of 450 to 500ml per min, with cooler dialysate temperature (35.5°C). Intervention 2: Control group: standard 4hrs hemodialysis with fresenius 4008 series hemodialysis machines, with standard flow rate of 450 to 500ml per min, with standard dialysate temperature (37°C). Yes - There is a plan to make this available What will be shared: Effect of Cooler Dialysate Temperature on Haemodynamic Stability in Hypotensive Patients on Maintenance Haemodialysis When: Mar 25 To whom: Anyone who requests via email after sharing purpose of requirement Conditions: After taking consent from authors Where to obtain: Via email request How to obtain: Email request Comments:
public Muhammad Haseeb Lodhi
Rawalpindi
Rawalpindi Pakistan 46000 +92 324 5105840 hazahlodhi@gmail.com National University Of Medical Sciences scientific Muhammad Haseeb Lodhi
Rawalpindi
Rawalpindi Pakistan 46000 +92 324 5105840 hazahlodhi@gmail.com National University Of Medical Sciences Pakistan Patients from both genders. Ages between 18 to 60 years. On twice weekly Hemodialysis. Having systolic blood pressure (SBP) below 90mmHg or diastolic blood pressure (DBP) below 60mmHg or both. Patients with SBP above 90mmHg or mean arterial pressure ≥ 65 on pharmacological support . 18 years 60 years Both Patients having thyroid disease, anaemia, taking anti-hypertensive medications, recent heart attack, not willing to participate and pregnant females. N18 Chronic kidney disease (CKD) Treatment - Other Treatment - Other Intervention group: standard 4hrs hemodialysis with fresenius 4008 series hemodialysis machines, with standard flow rate of 450 to 500ml per min, with cooler dialysate temperature (35.5°C) Control group: standard 4hrs hemodialysis with fresenius 4008 series hemodialysis machines, with standard flow rate of 450 to 500ml per min, with standard dialysate temperature (37°C) Intradialytic hypotension comparison in patients of CKD on maintenance hemodialysis. Timepoint: During the HD session, intradialytic blood pressure and pulse rate changes were documented every hour and at the end of the session. Method of measurement: BP measured with Sphygmomonometer. National University Of Medical Sciences Approved 2024-08-01 Ethics committee of Pakistan Emirates Military Hospital Rawalpindi Rawalpindi Punjab Pakistan