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IRCT20220921056012N1 IRCT 2022-12-21 Rasht University of Medical Sciences Evaluation of the synergistic effect of coenzyme Q10 on contrast nephropathy Evaluation of the synergistic effect of coenzyme Q10 on the incidence of contrast nephropathy in patients with chronic kidney disease 2022-10-23 anticipated 210 Complete https://irct.ir/trial/66007 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The website http://www.jerrydallal.com/random/randomize.htm will be used for randomization. The randomization of this study will be by the blocked randomization method. Based on the list obtained from this website, each person will be randomly assigned to the control or intervention group using 6 random blocks with the number of 35 blocks in a ratio of 1:1. Using this method, each person is assigned one of the letters A or B to each group, and the list of codes obtained from this website will be provided to the project researchers for randomization, and each patient with chronic kidney disease with a GFR of less than 60 Those who meet the inclusion criteria will be entered the plan according to the assigned code. The steps to use this site will be as follows: we will enter the website through the http;//www.randomization.com link. Then, by entering the number of samples and the number of considered blocks, select the option on the left and the website will automatically generate the randomization list and people will be placed in the offending groups A and B, and the output file will be usable, Blinding description: For blinding, placebos completely identical in terms of color, smell, shape and size to the COQ10 drug will be prepared for this study. The COQ10 drug used for the patients of this project will also be placed in unlabeled cans without any label (only it is obvious to the person giving the medicine) and will be available to the patients. For this purpose, the COQ10 supplement will be placed in capsules of a large and appropriate size, and in contrast to the placebo, the same-sized capsule will be filled with a suitable filler such as lactose by a pharmaceutics colleague present at the Faculty of Pharmacy and will be given to the control group; to be similar in appearance. 3 Condition 1: Contrast-induced nephropathy. Condition 2: chronic kidney disease. Intervention 1: Control group: this group will receive standard and routine treatment in such a way that ACE, ARB, metformin and NSAID drugs will stopped and NAC drug 1200mg twice a day from 24 hours before receiving isosmolar contrast material to 48 hours after it, plus placebo will prescribed. Placebos will be completely identical to COQ10 in terms of color, smell, shape and size, and capsules of the same size as COQ10 will be filled with a suitable filler such as lactose and will be given to this group; to be similar in appearance. Intervention 2: Intervention group: In this group, in addition to the items mentioned in the control group, COQ10 supplement (with a dose of 100 mg) will be prescribed daily from 24 hours before receiving the contrast medium until 72 hours after it. 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 is no further information
public Parham Porteghali
15 Khordad Street, Rasht, Iran.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 3070 p.porteghali@gums.ac.ir Rasht University of Medical Sciences scientific Parham Porteghali
15 Khordad Street, Rasht, Iran.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 3070 p.porteghali@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) GFR lower than 60 age upper than 18 years 18 years no limit Both perform urgent PCI or CAG before receiving standard care 24 hours before receiving contrast presence of liver failure presence of multiple myeloma disease and other plasma cell disorders single kidney patients N 14.1 N18.9 Nephropathy induced by other drugs, medicaments and biological substances Chronic kidney disease, unspecified Placebo Treatment - Drugs Control group: this group will receive standard and routine treatment in such a way that ACE, ARB, metformin and NSAID drugs will stopped and NAC drug 1200mg twice a day from 24 hours before receiving isosmolar contrast material to 48 hours after it, plus placebo will prescribed. Placebos will be completely identical to COQ10 in terms of color, smell, shape and size, and capsules of the same size as COQ10 will be filled with a suitable filler such as lactose and will be given to this group; to be similar in appearance. Intervention group: In this group, in addition to the items mentioned in the control group, COQ10 supplement (with a dose of 100 mg) will be prescribed daily from 24 hours before receiving the contrast medium until 72 hours after it. Contrast nephropathy that occurs if Cr increases and urine volume decreases less than 0.5 cc/kg/h for at least 6 hours will be considered equivalent to acute kidney injury. Timepoint: In both groups, at the beginning and on the third and fifth days, the baseline level of Bun-Cr-GFR and in addition the amount of urine volume will be measured on days 0 and 3. Method of measurement: Blood and urine laboratory tests to check Bun-Cr-GFR and urine volume. Rasht University of Medical Sciences Approved 2022-08-28 Ethics committee of Guilan University of Medical Sciences in front of 17 Shahrivar Educational-Therapeutic Center, Shahid Siyadati St. Namjo St. ,Rasht Rasht Guilan Iran (Islamic Republic of)