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

Coronary Heart Disease Clinical Trial

— NEPHRON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00584350
• Other study ID #: 03-70-M5
• Status: Recruiting
• Phase: Phase 4
• First received: December 20, 2007
• Last updated: February 11, 2015
• Start date: November 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Université de Sherbrooke
• Contact: Michel Nguyen, MD, FRCPC
• Phone: 819 346-1110
• Email: michel.nguyen[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Kidney Diseases
• Myocardial Ischemia
• Radiographic Contrast Agent Nephropathy
• Renal Failure

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Canada	CHUS, clinical research center	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	changes in glomerular filtration in the 3 groups (measured with MDRD formula)		48 hours	Yes
Secondary	clinical events during the procedure or after (ex. pulmonary edema)		during hospitalisation	Yes
Secondary	Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours		48 hours	Yes