Evaluation of the combined effect of potassium citrate consumption and the comparison of double j stent in reducing the formation of urinary tract stones

Evaluation of the effect of potassium citrate administration on re-formation of stones on double j ureteral stents

Using the online site sealedenvelop.com (a site for sequencing randomized block), random blocks of patients in two groups A: Double j plus placebo B: Double j plus potassium citrate. The order of patient placement is provided to the technician. The study is Double blind (patient and surgeon). 70 patients referred to Sina Hospital will be studied. The study is interventional, phase 3, parallel and therapeutic.

This clinical trial will be performed on 70 patients at Sinai Hospital. All patients undergoing tul and pcnl and double j implantation are divided into two target groups (group A: double j plus placebo B: double j plus potassium citrate).double blind (patient and surgeon),Technician (importer of patients in each group based on random blocks), quadruple blocks are randomly made for patients in groups A and B, 17 quadruple blocks that are placed in separate envelopes.

Inclusion criteria: all people who had a Stent Dj after having kidney stones treated. Exclusion criteria: Having diabetes with poor blood control,Digoxin for heart problems,Concomitant use of calcium supplements,Taking potassium-sparing diuretics,Previous history of hypercalcemia,use of Levodopa,Blood sugar above 160 mg two hours after a meal despite taking diabetes medications,Take any amount of spironolactone, triamterene and amiloride tablets,High blood potassium more than 5,GFR less than 70,Pregnancy

Intervention group A: Patients receiving Double j with placebo. Intervention groupB: Patients receiving double j in addition to potassium citrate.

Re-formation of stone on Dj stent due to the presence of citrate and the absence of citrate

The present study is a double-blind randomized clinical trial. For randomization, the blanced block randomization method is used to generate quadruple blocks.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes.After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the (A) double j plus placebo or (B)double j plus potassium citrate treatment group.

Patients who have agreed to participate in the study and the therapist for the blinding process, envelopes related to the type of intervention are provided only to the technician. The physician (to avoid bias) and the patient are not informed of the type of intervention (double j plus placebo or double j plus potassium citrate).

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Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560

After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.