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IRCT20220110053680N1 IRCT 2022-12-09 Zanjan University of Medical Sciences effect of aspirin on permanent Internal Jugular dialysis catheter patency Evaluation of the effect of aspirin consumption on permanent Internal Jugular dialysis catheter patency in End Stage Renal Disease (ESRD) patients 2022-07-23 anticipated 84 Complete https://irct.ir/trial/62375 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Other design features: 84 samples are randomly divided into two control and intervention groups and 80 mg aspirin is given to the intervention group and placebo to the control group daily for 6 months, Randomization description: The samples will be randomly assigned to one of the two control and intervention groups, which will use Excell 2016 edition for randomization. To do this, we enter 42 numbers 1 and 42 numbers 2 in the first column. Then in the second column we use the RAND () function and generate 84 random numbers. We arrange the data based on, column including values of random numbers (ascending or descending). With this sorting, the order of numbers 1 and 2 in the first column will also change and be placed randomly. Based on the order of appearance of numbers 1 or 2 and according to the list of names of people included in the study, the samples are assigned to 2 groups, Blinding description: The main researchers and data analysts will know which group each of the samples are in, but the samples themselves will be told that the drug given to them is aspirin, and the side effects of aspirin will be explained to the patients and consent Admission to the study is taken. Therefore, the samples will not know which control or intervention group they are in. The main researchers are responsible for data collection, and in this study, the only communication will be between the main researchers and the patients, and other than the person responsible for data analysis, no other people will have a role in this study. 3 end stage renal disease (ESRD) , patency of internal jugular permcath , aspirin consumption. Intervention 1: Intervention group: Receive 80 mg aspirin orally, once a day , for 6 months, made by Parsdarou Company The survival time of the catheter is recorded from the time of the start of Aspirin use to the failure of the catheter. The evaluation of the catheter function and the continuation of the patient's medication will be weekly. Intervention 2: Control group: receive placebo orally, 1 tablet per day, for 6 months, made by Faculty of Pharmacy, Zanjan University of Medical Sciences with formulation of : Avicel 102 (0.17g) + HPMC ( 0.004g) + Propylene glaco (0.005g) + Titanium dioxide ( 0.0001g) + FD & C yellow No 10 (0.00001g) + talc ( 0.0014g) The survival time of the catheter is recorded from the time of the start of placebo use to the failure of the catheter. The evaluation of the catheter function and the continuation of placebo consumption in the patient will be weekly. 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 There isn't more information.
public Hanieh Davoodi
Karmandan Town - Phase 2 - West 4th Street - No. 813 - Unit 3
Zanjan Iran (Islamic Republic of) 4513994943 +98 24 3344 3965 md.101.2512@gmail.com Zanjan University of Medical Sciences scientific Nadia Agharafiei
Shahre Ziba neighborhood - Shahre Ziba square - Ashouri street - end of Bahar alley - No.16 - Unit 3
Tehran Iran (Islamic Republic of) 1486946878 +98 21 4435 9882 nadia.agharafiei@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patient has ESRD and Glomerular Filtration Rate (GFR) <15ml / min / 1.73 m^2. At least one month should be passed since the start of hemodialysis maintenance. At least one month and at most one year should be passed since the installation of the internal jugular permcath . There shouldn't have any definitive contraindication for normal use of aspirin no limit no limit Both Current aspirin use at the time of entrance in the study Presence of a known underlying disease that increases the risk of thrombosis (lupus, antiphospholipid syndrome, presence of nephrotic syndromes) use of anticoagulants (warfarin, heparin, apixaban, rivaroxaban, plavix) use of Tarulac Catheter infection before beginning the study Incomplete patient document regarding the items required in the study Patient disfavor with inclusion in the study Z45.2 Encounter for adjustment and management of vascular access device Treatment - Drugs Placebo Intervention group: Receive 80 mg aspirin orally, once a day , for 6 months, made by Parsdarou Company The survival time of the catheter is recorded from the time of the start of Aspirin use to the failure of the catheter. The evaluation of the catheter function and the continuation of the patient's medication will be weekly. Control group: receive placebo orally, 1 tablet per day, for 6 months, made by Faculty of Pharmacy, Zanjan University of Medical Sciences with formulation of : Avicel 102 (0.17g) + HPMC ( 0.004g) + Propylene glaco (0.005g) + Titanium dioxide ( 0.0001g) + FD & C yellow No 10 (0.00001g) + talc ( 0.0014g) The survival time of the catheter is recorded from the time of the start of placebo use to the failure of the catheter. The evaluation of the catheter function and the continuation of placebo consumption in the patient will be weekly. Duration of internal jugular permcath patency. Timepoint: Weekly. Method of measurement: Number of days that permcath has function during the 6 month of the study. Duration of time that patient has suffered from End Stage Renal Disease (ESRD). Timepoint: At onset of study. Method of measurement: Number of months passed since the diagnosis of ESRD and onset of hemodialysis. History of heart failure. Timepoint: At onset of the study. Method of measurement: Ejection Fraction (EF) less than 50% according to echocardiography record in patient's file. Hypertension. Timepoint: At onset of the study and in patients with hypertension, weekly until the end of the study. Method of measurement: Systolic blood pressure (SBP) ≥ 140 mmHg or Diastolic blood pressure (DBP) ≥ 90 mmHg according to patient's file. Diabetes mellitus. Timepoint: At onset of the study. Method of measurement: Fast Blood Sugar (FBS) ≥ 126 mg/dl according to patient's file. Age. Timepoint: At onset of the study. Method of measurement: Asking from patient. Sex. Timepoint: At onset of the study. Method of measurement: Observation. Zanjan University of Medical Sciences Approved 2022-07-13 Ethics committee of Zanjan University of Medical Sciences Zanjan , Azadi Blvd , Research and Technology Vice-Chancellor, 1st Floor , Ethics Committee in Biomedical Research Zanjan Zanjan Iran (Islamic Republic of)