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

NCT00514150 | Completed Phase 3

• 1 other identifier: 85-02-30-3595(1)
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Induced Nephropathy

Keywords

angiography; complications; contrast media; kidney; prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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.

  at day 5

• Days in hospital within the month post contrast

  whithin the month post contrast

• Urine PH after initial bolus

  whithin 6 hours after initial bolus

• development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours.

  at 48 hours

• development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5.

  at day 5

Study Arms (2)

1

ACTIVE COMPARATOR

1075 cc of 154 mEq/L solution of NaCl 0.9% , prepared by adding 75 cc of 154 mEq/L NaCl 0.9 % to 1000 cc of 154 mEq/L NaCl 0.9%

Drug: normal saline 0.9%

2

ACTIVE COMPARATOR

1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%.

Drug: Sodium Bicarbonate plus normal saline 0.9%

Interventions

Sodium Bicarbonate plus normal saline 0.9% DRUG

IV sodium bicarbonate 8.4% solved in 154 mEq/ L NaCl 0.9% (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.

2

normal saline 0.9% DRUG

IV 154 mEq/L solution of NaCl 0.9% (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.)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Tehran Heart Center: collaborator

Study Sites (1)

Tehran Heart Center

Tehran, 1411713138, Iran

Location

MeSH Terms

Interventions

Sodium Bicarbonate; Saline Solution

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ali Vasheghani-Farahani, M.D.

  Tehran University of Medical Sciences, Tehran Heart Center

  STUDY DIRECTOR

• Ebrahim Kassaian, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Akbar Fotuhi, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Mohammad Reza Khatami, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Mojtaba Salarifar, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Ahmad Iaminisharif, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Saeid Sadeghian, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Gholamreza Davoodi, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Alireza Amirzadegan, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Sirus Darabian, M.D.

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Gelareh Sadigh, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Amir Hossein Razavi, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammad Ali Mansournia, MD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammad Ali Boroumand, MD

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

• Farah Aiatollahzade Esfehani, BSc,RN

  Tehran Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 5, 2008

Record last verified: 2008-09

Locations

IR (1)