Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy (CIN)
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.