Clinical trial NCT00513825: Preventing Contrast Nephropathy With Sodium Bicarbonate in Patients With Pulmonary Edema,Heart Failure,Uncontrolled HTN
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contrast Induced Nephropathy
Keywords: Contrast Nephropathy
Sodium Bicarbonate
Prevention
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2007-08-09
Enrollment: 72
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.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.

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 .

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.

Eligibility criteria: Inclusion Criteria:

* individuals aged 18 years or older with serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography.
* Patients with a history of Pulmonary edema or
* Patients with severe Heart Failure ( NYHA 3-4) or
* Patients with ejection fraction of less than 30% on Echocardiography ( done in the previous month of admission) or
* Patients with uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg )

Exclusion Criteria:

* serum creatinine levels of more than 8 mg/dl
* previous history of dialysis
* GFR \< 20 ( as calculated with this formula: ((140-Age)(Weight(Kg)) / Serum Creatinine(mg/dl) ×72 ) , in females GFR was multiplied by 0.85 )
* emergency catheterization
* recent exposure to radiographic contrast agents (within previous two days of the study)
* radiocontrast agent dosage needed more than 300 gr 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

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: an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent.
timeFrame: at day 5
measure: Urine PH after initial bolus
timeFrame: within 6 hours after initial bolus
measure: development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours.
timeFrame: at 48 hours
measure: development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 .
timeFrame: on day 5 post contrast
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 Farahani Vasheghani, 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: Ebrahim Nematipur, 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: Ali mohammad Hajzeinali, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Mohammad Alidoosti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Hamidreza Purhosseini,, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Ali Kazemisaeid, 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: Abbas Soleimani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Sirus Darabian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran Heart Center
name: Kianush Hossein, 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
References: