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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)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015050322065N1
Enrollment
190
Registered
2015-08-13
Start date
2014-10-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced nephropathy. Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

Interventions

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 potassi
Prevention
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
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 granu

Sponsors

Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Ghorbani

Ahvaz Jundishapur University of Medical Sciences, medical school, Golestan hospital, internal medici

golestanhospital@ajums.ac.ir; ali.ghorbani.001@gmail.com; dralighorbani@yahoo.com+98 61337430019

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026