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IRCT2015050322065N1 IRCT 2015-08-13 Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences prevention of kidney injury caused by contrast media during angioplasty/graphy by adminstration of sodium potassium citrate solution - prevention of contrast induced nephropathy(CIN) in pateints with some degree of chronic kidney disease (CKD) undergoing coronary angioplasty/graphy with sodium potassium citrate solution(shohl's solution) 2014-10-23 anticipated 190 Complete https://irct.ir/trial/19124 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: -. 3 contrast induced nephropathy. Intervention 1: patients in intervention arm of the study will receive 1 ml/kg/h 0.9% sodium chloride 12 h before and after the procedure. in this group patients will receive 7.5 g of sodium potassium citrate granules (Uralyt U,Germany) diluted in 200 mL of water two times before and after the operation. Intervention 2: patients in placebo arm of the study will receive 1 ml/kg/h 0.9% sodium chloride 12 h before and after the procedure. in this group patients will receive 200 mL of water ,as placebo, two times before and after the operation.

public Dr Ali Ghorbani

Internal medicine department, Golestan hospital, Farvardeen street, Golestan Hwy, Ahvaz

Ahvaz Iran (Islamic Republic of) 61357-33118 +98 61337430019 golestanhospital@ajums.ac.ir; ali.ghorbani.001@gmail.com; dralighorbani@yahoo.com Ahvaz Jundishapur University of Medical Sciences, medical school, Golestan hospital, internal medici scientific Dr Ali Ghorbani

Internal medicine department, Golestan hospital, Farvardeen street, Golestan Hwy, Ahvaz

Ahvaz Iran (Islamic Republic of) 61357-33118 +98 61337430019 golestanhospital@ajums.ac.ir; ali.ghorbani.001@gmail.com Ahvaz, Jundishapur University of Medical Sciences, medical school, Golestan hospital, internal medic Iran (Islamic Republic of) Inclusion criteria: all adult patients (more than 18 years old) candidate for elective coronary angioplasty/graphy and have CKD (at least stage 2) Exclusion criteria: ESRD (GFR less than 15cc per min); AKI; exposure to contrast within last 10 days; history of sensitivity to contrast media; pulmonary edema; multiple myeloma; history of (diarrhea, vomiting, dehydration status, bleeding); pregnancy; drug history of (NAC, teofiline, dopamine, fenoldopam, manitol and NaHCO3) 48 hours before intervention; consumption of nephrotoxic drugs 48 hours before till one week following the intervention; electrolytes disturbance (i.e hyperkalemia or alkalosis) or GFR more than 90 cc per min; refusal to participate no limit no limit Both N 14 Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions Prevention Prevention patients in intervention arm of the study will receive 1 ml/kg/h 0.9% sodium chloride 12 h before and after the procedure. in this group patients will receive 7.5 g of sodium potassium citrate granules (Uralyt U,Germany) diluted in 200 mL of water two times before and after the operation. patients in placebo arm of the study will receive 1 ml/kg/h 0.9% sodium chloride 12 h before and after the procedure. in this group patients will receive 200 mL of water ,as placebo, two times before and after the operation. Contrast induced nephropathy defined as (an absolute increase of at least 0.5 mg/dl or a relative increase 25% or more from baseline serum Cr or a reduction in GFR at least 25% or more from baseline value. Timepoint: Serum creatinine concentration will be checked at the time of admission and and on days 2,5 after the expose to contrast. Method of measurement: Serum creatinine concentration will be assessed using biochemistry method. In-hospital death or mortality following CIN development. Timepoint: in-hospital follow up and post-discharge follow up based on patern of serum cratinine change and ultimately one month after CIN development. Method of measurement: via visiting patient. Need for dialysis or hemofiltration following CIN. Timepoint: will be evaluated based on the patern of serum cratinine changes following CIN development. Method of measurement: via visiting patient and assessment of patients serum cratinine and electrolytes status. Need for readmission following CIN development. Timepoint: based on the paterns of serum cratinine changes following CIN development. Method of measurement: via visiting patient and assessment of patients serum cratinine and electrolytes status. Mean peak increase in serum cratinine following CIN development. Timepoint: via assessing serum cratinine on days 2 and 5 following CIN development. Method of measurement: via assessing serum cratinine using biochemichal assays. Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences Approved 2014-11-15 Ethics committee of Ahvaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Hwy, Ahvaz, Khuzestan, Iran Ahvaz Iran (Islamic Republic of)