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

Primary Purpose

Radiographic Contrast Agent Nephropathy, Renal Failure, Coronary Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Hydratation according LVEDP + NaHCO3
normal saline
Sodium bicarbonate
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiographic Contrast Agent Nephropathy focused on measuring coronary angiogram, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHUS, clinical research centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

A: Hydratation according LVEDP + NaHCO3

B: Standard hydratation

C: Hydratation with sodium bicarbonate

Arm Description

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.

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).

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).

Outcomes

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.

Secondary Outcome Measures

changes in glomerular filtration in the 3 groups (measured with MDRD formula)
clinical events during the procedure or after (ex. pulmonary edema)
Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours

Full Information

First Posted
December 20, 2007
Last Updated
February 11, 2015
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT00584350
Brief Title
Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
Acronym
NEPHRON
Official Title
Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiographic Contrast Agent Nephropathy, Renal Failure, Coronary Heart Disease
Keywords
coronary angiogram, percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Hydratation according LVEDP + NaHCO3
Arm Type
Experimental
Arm Description
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.
Arm Title
B: Standard hydratation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
C: Hydratation with sodium bicarbonate
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Hydratation according LVEDP + NaHCO3
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Sodium bicarbonate
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
changes in glomerular filtration in the 3 groups (measured with MDRD formula)
Time Frame
48 hours
Title
clinical events during the procedure or after (ex. pulmonary edema)
Time Frame
during hospitalisation
Title
Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Nguyen, MD, FRCPC
Phone
819 346-1110
Ext
15251
Email
michel.nguyen@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Nguyen, MD, FRCPC
Organizational Affiliation
Sherbrooke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS, clinical research center
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Nguyen, MD, FRCPC

12. IPD Sharing Statement

Learn more about this trial

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

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