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

NCT00584350 | Unknown Phase 4 DMC

• 1 other identifier: 03-70-M5
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Keywords

coronary angiogram; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

A: Hydratation according LVEDP + NaHCO3

EXPERIMENTAL

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.

Other: Hydratation according LVEDP + NaHCO3

B: Standard hydratation

ACTIVE COMPARATOR

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).

Other: normal saline

C: Hydratation with sodium bicarbonate

EXPERIMENTAL

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).

Other: Sodium bicarbonate

Interventions

Hydratation according LVEDP + NaHCO3 OTHER

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.

A: Hydratation according LVEDP + NaHCO3

normal saline OTHER

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).

B: Standard hydratation

Sodium bicarbonate OTHER

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).

C: Hydratation with sodium bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CHUS, clinical research center

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Coronary Disease

Interventions

Sodium Bicarbonate; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michel Nguyen, MD, FRCPC

  Sherbrooke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Nguyen, MD, FRCPC

CONTACT

819 346-1110; michel.nguyen@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

CA (1)