Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384995
Status:
TERMINATED
Last Update Posted:
2010-12-01
First Post:
2006-10-05
Brief Title:
Bicarbonate v Saline to Prevent Contrast Nephropathy
Sponsor:
Italian Society of Nephrology
Organization:
Italian Society of Nephrology
Study Overview
Official Title:
Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy CAN-IT PREVENT Protocol
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Slowing of kidney function occurs in a minority of people given dye during angiography The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury salt in water or baking soda in water
Detailed Description:
A decline in kidney function after contrast is associated with prolonged hospital stay adverse cardiac events and higher mortality both in hospital and in the long term Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy However data to support specific recommendations are lacking and the optimal fluid regimen remains unclear
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels A recent trial found a lower frequency of creatinine rise 25 within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion Merten GJ JAMA 2004 However it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws
Comparison IV 16 M sodium bicarbonate OR IV 09 saline each isotonic fluid given at the same rate of sodium administration 325 mlKg over 1 hour pre-contrast followed by 11 mlKghr for 6 hours for bicarbonate 35 mlKg over 1 hour pre-contrast followed by 12 mlKghr for 6 hours for saline Total infusion time 7 hours for both Maximum rate of fluid permitted is that for a body weight of 110 Kg Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels A recent trial found a lower frequency of creatinine rise 25 within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion Merten GJ JAMA 2004 However it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws
Comparison IV 16 M sodium bicarbonate OR IV 09 saline each isotonic fluid given at the same rate of sodium administration 325 mlKg over 1 hour pre-contrast followed by 11 mlKghr for 6 hours for bicarbonate 35 mlKg over 1 hour pre-contrast followed by 12 mlKghr for 6 hours for saline Total infusion time 7 hours for both Maximum rate of fluid permitted is that for a body weight of 110 Kg Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None