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

Phase 4

• Conditions: Renal Failure; Coronary Heart Disease; Radiographic Contrast Agent Nephropathy
• Interventions: Other: normal saline; Other: Sodium bicarbonate; Other: Hydratation according LVEDP + NaHCO3

• Registration Number: NCT00584350
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2008-01-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Standard hydratation	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).
C: Hydratation with sodium bicarbonate	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).
A: Hydratation according LVEDP + NaHCO3	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.

Primary Outcome Measures

Name	Time	Method
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.	48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHUS, clinical research center; 🇨🇦 Sherbrooke, Quebec, Canada