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.

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.

The present study is a clinical trial with a control group, with parallel groups, randomized (using block randomization), phase 3 on 162 patients.

In this double-blind randomization clinical trial, patients who are candidates for tunneled central venous catheters referring to Amir al-Momenin Hospital in Arak will be divided into three equal groups of Atorvastatin, aspirin, and control by means of block randomization. In this study, patients (by placebo pills) and outcome assessors (by patient coding) will be blinded. In each group, drug treatment will be prescribed daily for 6 months. Finally, three groups will be evaluated in terms of study results.

Inclusion criteria: candidates for central venous catheterization for whom a tunneled catheter will be implanted, having consent to participate in the study. Exclusion criteria: the presence of a history of coagulation diseases, the presence of a disease that has contraindications for taking aspirin (such as nasal polyp disease, asthma, allergy to aspirin).

Atorvastatin group: daily consumption of one 40 mg Atorvastatin tablet from Soban Daru Company from the day of catheter placement until 6 months or catheter removal. Intervention group: daily consumption of an 80 mg aspirin tablet from Galenos company from the day of catheter placement until 6 months or catheter removal. Control group: daily use of placebo tablets for 6 months

Duration of catheter operation, catheter infection, thrombosis, 180 days operation.

The age range has changed from 20-55 years to 20-65 years.

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.

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.

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.

Access will be from 2024/07/20 to 2027/07/20 for 3 years.

University researchers

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.

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

Letter writing should be done with professors and universities.