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IRCT20200202046335N1 IRCT 2020-05-13 Kermanshah University of Medical Sciences Crocin in acute kidney injury CEPCIN Evaluation of Crocin effect on the contrast induced nephropathy following coronary angiography or angioplasty: A randomized controlled trial 2019-08-29 anticipated 100 Complete https://irct.ir/trial/46409 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignment. For example, if you had treatment groups A and B, and you plan to enroll 20 new patients, your blocks might look like this: B B A B A A B A B B A A B A A B B A B A this means first patient goes to treatment group B, second patient goes to group B... Note that each block has 10 As and 10Bs, maintaining a balance of the two despite the random order, Blinding description: Since both groups in this clinical trial receive standard pre-treatment hydration protocol in order to prevent contrast-induced nephropathy( CIN), first participants are provided with information regarding their risk of developing CIN and the need to hydrated enough with or without Crocin. They are told that they might benefit from taking Crocin or not, but there is no side effect for sure. Then the control group takes placebo while the intervention group takes three doses of Crocin for three days. Neither participants nor nurses and laboratory assistants are aware of allocations. 3 Contrast induced nephropathy. Intervention 1: Intervention group: 3 consecutive oral doses of 30 mg crocina brand tablets. before and 24 and 48 hrs after PCI. of note is that since crocina tablets are 15 mg, each time the patient is given two tablets at the same time. Intervention 2: Control group: 3 consecutive oral doses of placebo before and 24 and 48 hrs after PCI. Yes - There is a plan to make this available What will be shared: The primary outcome measure after identifying When: After publication To whom: Academic institutions and people working in businesses Conditions: as a base for other researches Where to obtain: Dr. Shima Esfandyari's email: esfandyarishyma@gmail.com How to obtain: Maximum one month after delivering the email Comments:
public Shima Esfandyari
5th floor, Kakh building, Western Khorram avenue, Golrizan street
Kermanshah Iran (Islamic Republic of) 6714657495 +98 83 3843 8310 esfandyarishyma@gmail.com Kermanshah University of Medical Sciences scientific Shima Esfandyari
5th floor, Kakh building, Western Khorram avenue, Golrizan street
Kermanshah Iran (Islamic Republic of) 6714657495 +98 83 3843 8310 esfandyarishyma@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Undergoing coronary or peripheral angiography with or without intervention Cr > 1.2 mg/dL and 30 <GFR < 60 mL/min Systolic pressure of greater than 90 mm Hg No contraindications to hydration or contrast agent 18 years no limit Both History of hypersensitivity to saffron End-stage renal disease on dialysis Acute renal failure Pregnancy or lactation Emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock Patient receiving N-acetylcysteine or sodium bicarbonate Platelets less than or equal to 100,000/mm3 Left Ventricular ejection fraction less than 30 History of Kidney transplant N14.1 Nephropathy induced by other drugs, medicaments and biological substances Prevention Placebo Intervention group: 3 consecutive oral doses of 30 mg crocina brand tablets. before and 24 and 48 hrs after PCI. of note is that since crocina tablets are 15 mg, each time the patient is given two tablets at the same time. Control group: 3 consecutive oral doses of placebo before and 24 and 48 hrs after PCI. BUN & Creatinin. Timepoint: Before intervention and 24 and 72 hrs after that. Method of measurement: blood urine nitrogen and creatinine lab test. (NGAL)Neutrophilic Gelatinase Associated Lipocaline. Timepoint: before and 8 hrs after angiography. Method of measurement: urine sample collection in urine sample containers. Kermanshah University of Medical Sciences Approved 2020-02-03 Ethics committee of Kermanshah University of Medical Sciences 5th floor, Kakh building, Western Khorram avenue, Golrizan street Kermanshah Kermanshah Iran (Islamic Republic of)