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IRCT20140802018649N4 IRCT 2019-07-08 Gorgan University of Medical Sciences Effect of ultrafiltration profiling on hypotention during hemodialysis Effect of liner, step-wise and functional ultrafiltration profiling on hypotension during hemdialysis in patients with chronic renal failure 2019-07-20 anticipated 32 Complete https://irct.ir/trial/36346 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: 32 patients will be randomly blocked into four groups. Each block contains the letters A, B, C, and D, which patients will randomly place in these blocks. Then, the four groups will receive four different treatment protocols. Subjects in Group A will first receive Protocol 1, then 2, 3, and 4. Group B receives protocol 2, then 3, 4 and 1. Group C will also receive protocols 3, 4, 1 and 2, respectively. Group D will receive protocol 4, then 3, 2, and 1, Blinding description: The patient does not know that will be in which one of the four groups of treatment protocols. N/A Chronic kidney disease. Intervention 1: Intervention group1: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.At first, Protocol 1 include linear profiles of ultrafiltration, then protocol 2 including stepwise profiles, protocol 3 including functional profiles of ultrafiltration and protocol 4 include of fixed ultrafiltration, each one for 2 weeks. Intervention 2: Intervention group2: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 2 included a stepwise profile , then protocol 3: functional profile, protocol 4 include of fixed ultrafiltration, and protocol 1 containing linear ultrafiltration, each one for 2 weeks. Intervention 3: Intervention group3: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below. First, protocol 3 includes functional profiles, then protocol 4 including fixed ultrafiltration, next protocol 1 of linear ultrafiltration, and at the end protocol 2, including stapwise ultrafiltration profiles, each one for 2 weeks. Intervention 4: Intervention group: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 4 including fixed ultrafiltration, then protocol 1 of linear ultrafiltration, next protocol 2, including stapwise ultrafiltration and at the end protocol 3 includes functional profiles, each one for 2 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Khadijeh Yazdi
Shast Kola road, Falsafi Campus, booyeh Nursing and Midwifery school
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 6900 yazdi@goums.ac.ir Gorgan University of Medical Sciences scientific Saeid Amir Khanloo
Sast Kola Road, Fasafi educational campus, Medical Faculty
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1442 amirkhanloo@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) getting end stage renal failure hemoglobin>10 history of dialysis 3 months at least Dialysis 3 times a week Systolic blood pressure above 100 mm Hg before dialysis Not use anti-hypertensive medication 4 hours before dialysis 18 years 65 years Both Classes 3 and 4 of Heart Failure Hepatic Impairment N18.5 Chronic kidney disease Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group1: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.At first, Protocol 1 include linear profiles of ultrafiltration, then protocol 2 including stepwise profiles, protocol 3 including functional profiles of ultrafiltration and protocol 4 include of fixed ultrafiltration, each one for 2 weeks. Intervention group2: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 2 included a stepwise profile , then protocol 3: functional profile, protocol 4 include of fixed ultrafiltration, and protocol 1 containing linear ultrafiltration, each one for 2 weeks. Intervention group3: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below. First, protocol 3 includes functional profiles, then protocol 4 including fixed ultrafiltration, next protocol 1 of linear ultrafiltration, and at the end protocol 2, including stapwise ultrafiltration profiles, each one for 2 weeks. Intervention group: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 4 including fixed ultrafiltration, then protocol 1 of linear ultrafiltration, next protocol 2, including stapwise ultrafiltration and at the end protocol 3 includes functional profiles, each one for 2 weeks. Blood pressure. Timepoint: before hemodialysis, 1 hour, 2 hours, 3 hours and after hemodialysis. Method of measurement: sphygmomanometer. Gorgan University of Medical Sciences Approved 2019-02-17 Ethics Committee of Golestan University of Medical Sciences Booyeh Nursing and Midwifery Faculty, Falsafi educational Campus, Beginning of Shast Kola Road, Gorgan Gorgan Golestan Iran (Islamic Republic of)