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IRCT20191104045328N20 IRCT 2024-03-28 Arak University of Medical Sciences Investigating the effect of atorvastatin and aspirin on the durability and function of the central venous catheter for dialysis Comparison of the effect of atorvastatin and aspirin on the durability and performance of tunneled catheters in patients who are candidates for central venous catheter insertion for dialysis. 2024-03-12 anticipated 162 Complete https://irct.ir/trial/75841 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to three groups of Atorvastatin, Aspirin and Placebo based on the order of arrival and based on the randomization sequence that will be produced in advance. This sequence is unpredictable, and its arrangement is completely random. Block randomization method with 9 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes that can arrange 3 letters A, B and C in a block of 9 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope, Blinding description: This study is double blind. In this way, for atorvastatin and aspirin tablets, starch tablets similar to atrostatin and aspirin will be prepared, which will be given to the opposite group and the placebo group. Therefore, each person in the study receives one pill from the supervisor, one of which is the drug in question and the other is a placebo, and in the placebo group, the person will take two placebo pills. For the second type of blinding, the drugs are prescribed by the relevant supervisor (principal guide) and are provided to the patients. The assistant of the relevant specialty does not know the type of prescription drugs of the patients and will only be responsible for collecting their clinical information through the checklist and file number. 3 Dialysis. Intervention 1: Intervention group: Daily consumption of a 40 mg Atorvastatin tablet of Soban Daru company, along with a placebo aspirin tablet, from the day of catheter placement until 6 months or catheter removal. Intervention 2: Intervention group: Daily consumption of an 80 mg aspirin tablet by Galenus company along with a placebo tablet of atorvastatin from the day of catheter placement until 6 months or catheter withdrawal. Intervention 3: Control group: Daily consumption of two starch tablet as ordered by Soban Daru from the day of catheter placement until 6 months or catheter removal. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2024/07/20 to 2027/07/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: Academic researchers and university professors can request Dr. Reza Shojaei to use the data after contacting the relevant professor via message or email. Dr. Reza Shojaei: Phone: 09123700960 Email: R.shojaei@arak.mu.ac.ir Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Reza Shojaei
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 R.shojaei@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Elham Farahani
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3532 e.farahani@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Candidate patients for central venous catheterization, for whom a tunneled catheter will be implanted. Surgery performed by a surgeon and resident Consent to participate in the study 20 years 65 years Both History of coagulopathy Existence of high blood pressure at the same time as diabetes Presence of fatty liver and liver disease based on confirmation by liver enzyme test The presence of a disease that has contraindications for taking aspirin (such as nasal polyp disease, asthma, allergy to aspirin) T80.21 Infection due to central venous catheter Treatment - Drugs Treatment - Drugs Placebo Intervention group: Daily consumption of a 40 mg Atorvastatin tablet of Soban Daru company, along with a placebo aspirin tablet, from the day of catheter placement until 6 months or catheter removal. Intervention group: Daily consumption of an 80 mg aspirin tablet by Galenus company along with a placebo tablet of atorvastatin from the day of catheter placement until 6 months or catheter withdrawal. Control group: Daily consumption of two starch tablet as ordered by Soban Daru from the day of catheter placement until 6 months or catheter removal. Duration of catheter operation. Timepoint: The beginning of the intervention until 180 days later. Method of measurement: checklist. Incidence of catheter infection. Timepoint: After the intervention. Method of measurement: checklist. Occurrence of thrombosis. Timepoint: After the intervention. Method of measurement: Clinical examination and ultrasound. 180 days operation. Timepoint: After the intervention. Method of measurement: Checklist. Arak University of Medical Sciences Approved 2023-08-29 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)