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

This study has been completed.
Sponsor:
Collaborator:
Tehran Heart Center
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00513825
First received: August 8, 2007
Last updated: November 23, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Contrast Induced Nephropathy
Drug: Sodium Bicarbonate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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. [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent. [ Time Frame: at day 5 ] [ Designated as safety issue: Yes ]
  • Urine PH after initial bolus [ Time Frame: within 6 hours after initial bolus ] [ Designated as safety issue: Yes ]
  • development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours. [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]
  • development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 . [ Time Frame: on day 5 post contrast ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
1075 cc of 77 mEq/L solution of NaCl 0.45% , prepared by adding 75 cc of 77 mEq/L NaCl 0.45 % to 1000 cc of 77 mEq/L NaCl 0.45%
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.
Active Comparator: 2
1075 cc fluid made by adding 75 cc of sodium bicarbonate solution 8.4% to 1000 cc of NaCl 0.45%.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513825

Locations
Iran, Islamic Republic of
Tehran Heart Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Tehran Heart Center
Investigators
Study Director: Ali Farahani Vasheghani, M.D. Tehran University of Medical Sciences, Tehran Heart Center
Principal Investigator: 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: Ebrahim Nematipur, 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: Ali mohammad Hajzeinali, M.D. Tehran Heart Center
Principal Investigator: Mohammad Alidoosti, M.D. Tehran Heart Center
Principal Investigator: Hamidreza Purhosseini,, M.D. Tehran Heart Center
Principal Investigator: Ali Kazemisaeid, 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: Abbas Soleimani, M.D. Tehran Heart Center
Principal Investigator: Sirus Darabian, M.D. Tehran Heart Center
Principal Investigator: Kianush Hossein, 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
  More Information

No publications provided

Responsible Party: Ali Vasheghani Farahani, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00513825     History of Changes
Other Study ID Numbers: 85-02-30-3595(2)
Study First Received: August 8, 2007
Last Updated: November 23, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Contrast Nephropathy
Sodium Bicarbonate
Prevention

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Pulmonary Edema
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Urologic Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014