prevention of kidney injury caused by contrast media during angioplasty/graphy by adminstration of sodium potassium citrate solutio

Phase 3

• Conditions: contrast induced nephropathy.; Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

• Registration Number: IRCT2015050322065N1
• Lead Sponsor: Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 190

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	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.