Overview

Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN)

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents. Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of normal saline in prevention of RCIN.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tehran University of Medical Sciences
Collaborator:
Tehran Heart Center
Criteria
Inclusion Criteria:

- individuals aged 18 years or older with stable serum creatinine levels of at least 1.5
mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery
angiography during the next 24 hours of hospitalization and were available until 5
days after the procedure for serum creatinine measurements.

Exclusion Criteria:

- serum creatinine levels of more than 8 mg/dl

- previous history of dialysis

- eGFR < 20

- emergency catheterization

- recent exposure to radiographic contrast agents (within previous two days of the
study)

- radiocontrast agent dosage needed more than 300 cc during the procedure

- allergy to radiocontrast agent

- pregnancy

- administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the
intended time of study

- need for continuous hydration therapy (e.g. sepsis )

- history of Multiple myeloma , Pulmonary edema , Uncontrolled hypertension (treated
systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than
100mmHg.) ,Severe heart failure (EF < 30% or NYHA 3-4).