Preventing Contrast Nephropathy With Sodium Bicarbonate in Patients With Pulmonary Edema,Heart Failure,Uncontrolled HTN

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513825
• Other study ID #: 85-02-30-3595(2)
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: November 23, 2008
• Start date: August 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases
• Pulmonary Edema

Intervention

Drug:
• Sodium Bicarbonate
IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Heart Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at 48 hours	Yes
Secondary	an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent.		at day 5	Yes
Secondary	Urine PH after initial bolus		within 6 hours after initial bolus	Yes
Secondary	development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours.		at 48 hours	Yes
Secondary	development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 .		on day 5 post contrast	Yes