Recruiting

Hydration with LEVDP

Sponsor:

Université de Sherbrooke

Code:

NCT00584350

Conditions

Radiographic Contrast Agent Nephropathy

Renal Failure

Coronary Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydratation according LVEDP + NaHCO3

normal saline

Sodium bicarbonate

Study Details

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.

Conditions

Radiographic Contrast Agent Nephropathy

Renal Failure

Coronary Heart Disease

Study ID

NCT00584350

Start date

Nov, 2007

Status verified date

Feb, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: A: Hydratation according LVEDP + NaHCO3

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: Standard hydratation

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

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).

Interventions

Hydratation according LVEDP + NaHCO3

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.

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).

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).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Michel Nguyen, MD, FRCPC

819 346-1110michel.nguyen@usherbrooke.ca

Locations

CHUS, clinical research center

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Principal Investigator:

Michel Nguyen, MD, FRCPC

More Information

Sponsor

Université de Sherbrooke

Last update posted

Feb 12, 2015

Last verified

Feb, 2015

Keywords

  • coronary angiogram
  • percutaneous coronary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2015-02-12.