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Bicarbonate v Saline to Prevent Contrast Nephropathy

This study is currently recruiting participants.
Verified by Italian Society of Nephrology, December 2006

Sponsors and Collaborators: Italian Society of Nephrology
European Commission
Memorial University of Newfoundland
Information provided by: Italian Society of Nephrology
ClinicalTrials.gov Identifier: NCT00384995
  Purpose

Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.


Condition Intervention Phase
Kidney Failure, Acute
Contrast Media
Drug: 0.9% (154 mEq/L) IV Sodium Chloride
Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate
Phase IV

MedlinePlus related topics:   Kidney Failure   

Drug Information available for:   Sodium chloride    Chlorides    Sodium bicarbonate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)

Further study details as provided by Italian Society of Nephrology:

Primary Outcome Measures:
  • Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.

Secondary Outcome Measures:
  • Group mean change in serum creatinine
  • Days in hospital within the week post contrast
  • Requirement for dialysis
  • Atheroembolic events
  • Major adverse cardiovascular events
  • Death

Estimated Enrollment:   1510
Study Start Date:   December 2006
Estimated Study Completion Date:   December 2008

Detailed Description:

A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.

It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.

Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Booked for cardiac or other non-renal arteriography
  • Pre-existing reduced kidney function: Serum Creatinine >= 1.3 & <= 4 mg/dl (female gender) or >= 1.5 & <= 5 mg/dl (male gender)
  • Age > 18 years

Exclusion Criteria:

  • GFR MDRD estimate < 15 ml/min/m2
  • End-stage renal disease already on dialysis
  • Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24 hours
  • Pulmonary edema - current or within 48 hours
  • Clinically relevant ascites, edema or other fluid overload
  • Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic)
  • Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support
  • Emergency (unplanned) angiography
  • IV contrast procedure
  • Exposure to iodinated radiocontrast within 3 days prior to study
  • Prior anaphylactoid reaction to contrast
  • Planned administration of N-acetylcysteine
  • Planned administration of dopamine, fenoldopam or mannitol
  • Current pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384995

Contacts
Contact: Pietro Ravani, MD, MSc     1-709-777 ext 8028     pietro.ravani@med.mun.ca    
Contact: Pietro Ravani, MD, MSc     39-0372-405 ext 379     p.ravani@ospedale.cremona.it    

Locations
Italy
Azienda Istituti Ospitalieri di Cremona     Recruiting
      Cremona, Italy, 26100
      Contact: Fabio Malberti, MD     +30-0372-405 ext 380     f.malberti.aioc@e-cremona.it    
      Principal Investigator: Fabio Malberti, MD            
Spedali Civili di Brescia     Not yet recruiting
      Brescia, Italy, 25100
      Contact: Francesco Scolari, MD     +39-030-3995 ext 628     fscolar@tin.it    
      Principal Investigator: Giovanni Cancarini, MD            
P.O. Uboldo     Not yet recruiting
      Cernusco sul Naviglio, Italy, 20063
      Contact: Ferruccio Conte, MD     +39-02-9236 ext 0320     contefc@tin.it    
      Principal Investigator: Ferruccio Conte, MD            

Sponsors and Collaborators
Italian Society of Nephrology
European Commission
Memorial University of Newfoundland

Investigators
Principal Investigator:     Pietro Ravani, MD, MSc     Italian Society of Nephrology    
Study Chair:     Brendan BJ Barrett, MD, MSc     Memorial University of Newfoundland    
Study Chair:     Ferruccio Conte, MD     Italian Society of Nephrology    
  More Information


Publications:

Publications indexed to this study:

Study ID Numbers:   PR021676
First Received:   October 5, 2006
Last Updated:   December 5, 2006
ClinicalTrials.gov Identifier:   NCT00384995
Health Authority:   Italy: Ministry of Health

Keywords provided by Italian Society of Nephrology:
Contrast Induced Nephropathy  
Chronic Kidney Disease  
Acute Renal Failure  
End-stage Renal Disease  
Cardiovascular diseases  
Coronary catheterization
Percutaneous coronary intervention
Intra-arterial angiography
Bicarbonate
Saline

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Kidney Failure, Chronic
Renal Insufficiency, Acute
Kidney Failure, Acute
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on October 29, 2008




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