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Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy (CIN)

NCT00749827 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-04-20

No results posted yet for this study

Summary

Contrast induced nephropathy (CIN) is a term applied to acute renal failure associated with intravascular injection of iodinated contrast agents typically used for cardiac angiography. CIN occurs in about 15% of those who have had cardiac angiography, with dialysis required by about 0.5% of cases. The development of CIN is associated with other adverse outcomes including major adverse cardiovascular events (MACE) and death. The mechanism underlying the association with MACE and death is unclear and it is largely unknown whether measures reducing the frequency or severity of CIN also reduce these associated adverse events.

The cause of CIN in humans is not known, but many preventive therapies have been tested based on our understanding of the mechanism underlying CIN from animal models. Despite multiple studies, no one drug or therapy has been proven to consistently prevent CIN at this time. Prophylactic fluid therapy is uniformly recommended as a component of preventive approaches for CIN. However, the optimal type, dose and duration of fluid therapy remain unclear. Existing studies suggest a role for isotonic saline\[3\] or bicarbonate\[4\]. Initial use of hypotonic fluid followed by isotonic fluid might allow a more rapid and sustained increase in tubular fluid flow by suppression of ADH. This should assist in reducing tubular fluid viscosity and the potential for injury by contrast medium.

The aim of this research program is to design and test strategies for the prevention of CIN in patients undergoing elective cardiac angiography or percutaneous coronary intervention (PCI). The primary purpose of this pilot study will be to determine the biological plausibility of using a hypotonic solution for CIN prophylaxis.

Specific Objectives:

Primary

1. To compare the effects of two fluid prophylaxis strategies for CIN on urine output, urine pH, urine composition (urine metabolic profiling), a novel marker of renal injury (NGAL) and urine osmolality Secondary
2. To assess the relative sensitivity of definitions of CIN based on changes in serum creatinine or cystatin C within 72 hours post contrast.
3. To determine the feasibility of a future multicenter randomized trial of a hypotonic fluid prophylaxis strategy for the prevention of radiocontrast nephropathy.

Conditions

  • Contrast Induced Nephropathy

Interventions

DRUG

Bicarbonate Hydration

Intravenous sodium bicarbonate (130 mEq/L) in 4.35% dextrose at 3.5 ml/Kg over 1 hour pre-contrast, followed by the same solution intravenously at 1 ml/Kg/hr for 6 hours. In all cases the maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular low-osmolal or iso-osmolal contrast (according to operator or institution choice) will be used in the minimal dose needed to complete the required imaging. Hypotonic hydration arm. Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.

DRUG

Hypotonic hydration

Intravenous 5% dextrose in water at 3.5 ml/Kg over 1 hour pre-contrast followed by 0.9% saline intravenously at 1 ml/Kg/hr for 6 hours.

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • Memorial University of Newfoundland

    lead OTHER

Principal Investigators

  • Brendan J. Barrett, MD M.Sc. · Memorial University of Newfoundland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749827 on ClinicalTrials.gov