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Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy (CIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Memorial University of Newfoundland.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Alberta
Information provided by:
Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT00749827
First received: September 5, 2008
Last updated: September 18, 2008
Last verified: September 2008
History of Changes
  Purpose

Contrast induced nephropathy (CIN) is a term applied to acute renal failure associated with intravascular injection of iodinated contrast agents typically used for cardiac angiography. CIN occurs in about 15% of those who have had cardiac angiography, with dialysis required by about 0.5% of cases. The development of CIN is associated with other adverse outcomes including major adverse cardiovascular events (MACE) and death. The mechanism underlying the association with MACE and death is unclear and it is largely unknown whether measures reducing the frequency or severity of CIN also reduce these associated adverse events.

The cause of CIN in humans is not known, but many preventive therapies have been tested based on our understanding of the mechanism underlying CIN from animal models. Despite multiple studies, no one drug or therapy has been proven to consistently prevent CIN at this time. Prophylactic fluid therapy is uniformly recommended as a component of preventive approaches for CIN. However, the optimal type, dose and duration of fluid therapy remain unclear. Existing studies suggest a role for isotonic saline[3] or bicarbonate[4]. Initial use of hypotonic fluid followed by isotonic fluid might allow a more rapid and sustained increase in tubular fluid flow by suppression of ADH. This should assist in reducing tubular fluid viscosity and the potential for injury by contrast medium.

The aim of this research program is to design and test strategies for the prevention of CIN in patients undergoing elective cardiac angiography or percutaneous coronary intervention (PCI). The primary purpose of this pilot study will be to determine the biological plausibility of using a hypotonic solution for CIN prophylaxis.

Specific Objectives:

Primary

  1. To compare the effects of two fluid prophylaxis strategies for CIN on urine output, urine pH, urine composition (urine metabolic profiling), a novel marker of renal injury (NGAL) and urine osmolality Secondary
  2. To assess the relative sensitivity of definitions of CIN based on changes in serum creatinine or cystatin C within 72 hours post contrast.
  3. To determine the feasibility of a future multicenter randomized trial of a hypotonic fluid prophylaxis strategy for the prevention of radiocontrast nephropathy.

Condition Intervention Phase
Contrast Induced Nephropathy
 Drug: Bicarbonate Hydration
Drug: Hypotonic hydration
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exploring the Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial University of Newfoundland:

Primary Outcome Measures:
  • Serum creatinine, cystatin C,and urine samples for measurement of urine pH, osmolality, electrolytes and creatinine,NGAL and metabolic profiling [ Time Frame: SeCr and Cystatin C will be collected at baseline 6hrs, 24, and 48 -72 hrs post cath, urine at baseline, pre-cath, and 6 hours post angiography ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous sodium bicarbonate (130 mEq/L) in 4.35% dextrose at 3.5 ml/Kg over 1 hour pre-contrast, followed by the same solution intravenously at 1 ml/Kg/hr for 6 hours
 Drug: Bicarbonate Hydration

Intravenous sodium bicarbonate (130 mEq/L) in 4.35% dextrose at 3.5 ml/Kg over 1 hour pre-contrast, followed by the same solution intravenously at 1 ml/Kg/hr for 6 hours. In all cases the maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular low-osmolal or iso-osmolal contrast (according to operator or institution choice) will be used in the minimal dose needed to complete the required imaging.

Hypotonic hydration arm. Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.

Other Name: Sodium Bicarbonate(130 mEq/L) in 4.35% dextrose
Active Comparator: 2
Hypotonic hydration arm. Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.
 Drug: Hypotonic hydration
Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.
Other Name: Dextrose(5%) in Water

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  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Booked for cardiac angiography and/or percutaneous coronary intervention
  • Pre-existing reduced kidney function (estimated GFR < 60 mls/min/1.73m2 by MDRD equation[18]).
  • Minimum age 20 years
  • Able to return to the study site for followup blood work.

Exclusion Criteria:

  • Estimated GFR < 15 mls/min/1.73m2 by MDRD equation
  • Already on dialysis
  • Known current acute kidney failure with serum creatinine rise of > 45 mol/L within 24 hours
  • Pulmonary edema - current or within 48 hours
  • Clinically significant ascites, edema or other fluid overload
  • Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic)
  • Unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for BP support
  • Emergency angiography
  • Planned primary PCI for acute coronary syndrome or myocardial infarction
  • Exposure to iodinated radiocontrast within 3 days prior to study
  • Prior anaphylactoid reaction to contrast
  • Planned administration of N-acetyl-cysteine, dopamine, fenoldopam or mannitol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749827

Contacts
Contact: Brendan J. Barrett, MD M.Sc. (709) 777-8073 bbarrett@mun.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Neesh Pannu, MD SM     (780) 407 8716     neesh.pannu@ualberta.ca    
Principal Investigator: Neesh Pannu, MD SM            
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Not yet recruiting
St. John's, Newfoundland and Labrador, Canada, A1S 1B9
Contact: Brendan J. Barrett, MD. MSc.     (709) 777-8073     bbarrett@mun.ca    
Principal Investigator: Brendan J. Barrett, MD MSc.            
Sponsors and Collaborators
Memorial University of Newfoundland
University of Alberta
Investigators
Principal Investigator: Brendan J. Barrett, MD M.Sc. Memorial University of Newfoundland
  More Information

No publications provided

Responsible Party: Dr. Brendan Barrett, Principal Investigator, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT00749827     History of Changes
Other Study ID Numbers: IIS-US-0048
Study First Received: September 5, 2008
Last Updated: September 18, 2008
Health Authority: Canada: Health Canada

Keywords provided by Memorial University of Newfoundland:
Contrast Induced Nephropathy, fluid prophylaxis

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013