Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP (NEPHRON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Michel Nguyen, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00584350
First received: December 20, 2007
Last updated: April 12, 2014
Last verified: April 2014
  Purpose

The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.


Condition Intervention Phase
Radiographic Contrast Agent Nephropathy
Renal Failure
Coronary Heart Disease
Drug: Normal saline and sodium bicarbonate
Drug: normal saline
Drug: Sodium bicarbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changes in glomerular filtration in the 3 groups (measured with MDRD formula) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • clinical events during the procedure or after (ex. pulmonary edema) [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
  • Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: November 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.

At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.

Drug: Normal saline and sodium bicarbonate

Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.

At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.

Active Comparator: B
hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
Drug: normal saline
hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
Experimental: C
hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
Drug: Sodium bicarbonate
hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).

  Eligibility

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

Inclusion Criteria:

  • minimum 18 years old
  • chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
  • hemodynamically stable

Exclusion Criteria:

  • Acute renal failure or in recuperation of acute renal failure
  • urgent coronary angiogram
  • moderate to severe valvulopathy or presence of a valvular prosthesis
  • diagnostic of multiple myeloma
  • dialysis before test
  • having had a test with contrast product in the 2 weeks preceding
  • receiving a nephrotoxic in the last month.
  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: NCT00584350

Contacts
Contact: Michel Nguyen, MD, FRCPC 819 346-1110 ext 15251 michel.nguyen@usherbrooke.ca

Locations
Canada, Quebec
CHUS, clinical research center Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Michel Nguyen, MD, FRCPC         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Michel Nguyen, MD, FRCPC Sherbrooke University
  More Information

No publications provided

Responsible Party: Michel Nguyen, Doctor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00584350     History of Changes
Other Study ID Numbers: 03-70-M5
Study First Received: December 20, 2007
Last Updated: April 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
coronary angiogram
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Kidney Diseases
Myocardial Ischemia
Renal Insufficiency
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014