Clinical trial NCT00514150: Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN)
Official title: Comparing Sodium Bicarbonate Plus Isotonic Normal Saline Versus Isotonic Normal Saline Alone to Prevent Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contrast Induced Nephropathy
Keywords: angiography
complications
contrast media
kidney
prevention
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2007-08-09
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Comparisons: IV 154 mEq/L solution of NaCl 0.9% OR IV 154 mEq/ L sodium bicarbonate solved in 154 mEq/ L NaCl 0.9%. 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.

Eligibility 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).

Primary outcomes:
measure: development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 48 hours after exposure to a contrast agent compared to baseline serum creatinine values.
timeFrame: at 48 hours
Secondary outcomes:
measure: development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 5 days after exposure to a contrast agent compared to baseline serum creatinine values.
timeFrame: at day 5
measure: Days in hospital within the month post contrast
timeFrame: whithin the month post contrast
measure: Urine PH after initial bolus
timeFrame: whithin 6 hours after initial bolus
measure: development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours.
timeFrame: at 48 hours
measure: development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5.
timeFrame: at day 5
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
Study officials:
affiliation: Tehran University of Medical Sciences, Tehran Heart Center
name: Ali Vasheghani-Farahani, M.D.
role: STUDY_DIRECTOR
affiliation: Tehran Heart Center
name: Ebrahim Kassaian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Akbar Fotuhi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Mohammad Reza Khatami, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Mojtaba Salarifar, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Ahmad Iaminisharif, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Saeid Sadeghian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Gholamreza Davoodi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Alireza Amirzadegan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Sirus Darabian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Gelareh Sadigh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Amir Hossein Razavi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Mohammad Ali Mansournia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Mohammad Ali Boroumand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Farah Aiatollahzade Esfehani, BSc,RN
role: PRINCIPAL_INVESTIGATOR
References: