Contrast Induced Nephropathy Clinical Trial
Official title:
The Evaluation of the Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN) in Patients With Pulmonary Edema,Severe Heart Failure or Uncontrolled Hypertension
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.But most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy of sodium bicarbonate solved in half saline compared with infusion of half saline in prevention of RCIN in these groups of patients.
Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients
undergoing diagnostic or interventional procedures requiring radiographic contrast agents
and is the third leading cause of acquired acute renal failure in hospitalized patients.
Strategies for the prevention of radiocontrast nephropathy have focused on countering
vasoconstriction (pre-hydration, fenoldopam, and theophylline), enhancing flow through the
nephron (diuretics), or protection against oxygen-free-radical injury (urinary
alkalinization and N-acetylcysteine).
Among all prophylactic measures that have been proposed, adequate preprocedural and
postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast
nephropathy. Thus, it remains the most frequently applied measure in clinical practice.
A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over
normal saline as a prophylaxy.Since alkalizing renal tubular fluid with bicarbonate may
reduce injury .
Most studies have excluded patients with history of pulmonary edema, severe heart
failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30% and no
specific protocol is tested for this group of patients. This study focuses on preventing
RCIN in this specific group of patients .
Comparisons:1075 cc NaCl 0.45% or 75 cc of sodium bicarbonate 8.4% solved in one liter of
NaCl 0.45%. Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the
angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the
procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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