AV Fistula Salvage in Advanced CKD Using Sodium Bicarbonate Prophylaxis
| Status: | Withdrawn |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/22/2018 |
| Start Date: | January 2008 |
| End Date: | November 2009 |
A Prospective Observational Study on the Use of Iodinated Contrast for AV Fistula Salvage in Stage 4/5 CKD Using Bicarbonate Prophylaxis
This is an observational study assessing the impact of conventional dose iodinated contrast
on the renal function of advanced chronic kidney disease patients undergoing arteriovenous
fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. In addition,
this model allows for pre and post procedure measurements of kidney function, providing a
unique opportunity to assess the utility of novel biomarkers for contrast-induced kidney
injury.
Our primary hypothesis is that there will be no change in serum creatinine post-procedure
when using a standard sodium bicarbonate prophylaxis protocol. Our secondary hypothesis is
that there will be no change in urinary kidney-injury marker-1 (KIM-1) post-procedure using a
standard sodium bicarbonate prophylaxis protocol. In addition, we will assess the impact of
different patient characteristics on the development of contrast-induced kidney injury, such
as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme
inhibitor therapy.
on the renal function of advanced chronic kidney disease patients undergoing arteriovenous
fistula evaluation using a standard sodium bicarbonate prophylaxis protocol. In addition,
this model allows for pre and post procedure measurements of kidney function, providing a
unique opportunity to assess the utility of novel biomarkers for contrast-induced kidney
injury.
Our primary hypothesis is that there will be no change in serum creatinine post-procedure
when using a standard sodium bicarbonate prophylaxis protocol. Our secondary hypothesis is
that there will be no change in urinary kidney-injury marker-1 (KIM-1) post-procedure using a
standard sodium bicarbonate prophylaxis protocol. In addition, we will assess the impact of
different patient characteristics on the development of contrast-induced kidney injury, such
as diabetes, coronary artery disease, hypertension, and angiotensin converting enzyme
inhibitor therapy.
The National Kidney Foundation publishes kidney disease outcome guidelines for improving care
of the chronic kidney disease (CKD) patient. Regarding hemodialysis vascular access, the
recommendation is for early placement of an arteriovenous fistula (AVF) to improve morbidity
and mortality outcomes, specifically when the glomerular filtration rate is less than
25ml/min, corresponding to stage 4 and 5 CKD. Despite its advantages, the need for
surveillance of the AVF to determine maturation for use and maintain optimal longevity
requires the use of interventional procedures. While radiocontrast use can lead to acute,
often reversible kidney injury, its use in AVF evaluation has renewed interest with the
recent implication of gadolinium-enhanced MRI being associated with a rare disorder of skin
swelling and induration called nephrogenic systemic fibrosis. CKD patients are particularly
susceptible to long term adverse outcomes from contrast-induced kidney injury, with 1 year
mortality in stage 4 and 5 CKD patients being 44% and 62%, respectively. While optimal fluid
therapy to prevent contrast-induced kidney injury remains uncertain, several prospective
randomized trials using sodium bicarbonate pretreatment have shown a lower incidence of
contrast-related kidney injury compared to isotonic saline. Traditional markers of acute
kidney injury, including serum creatinine, blood urea nitrogen, and creatinine clearance have
been insensitive in differentiating contrast-induced kidney injury from other forms of renal
injury. Kidney injury marker-1 (KIM-1) is a transmembrane receptor induced to very high
levels in the proximal tubule of the nephron following ischemic and nephrotoxic injury. KIM-1
has been shown in a small cohort of patients to differentiate ischemic kidney injury from
other forms of acute and chronic kidney disease.
of the chronic kidney disease (CKD) patient. Regarding hemodialysis vascular access, the
recommendation is for early placement of an arteriovenous fistula (AVF) to improve morbidity
and mortality outcomes, specifically when the glomerular filtration rate is less than
25ml/min, corresponding to stage 4 and 5 CKD. Despite its advantages, the need for
surveillance of the AVF to determine maturation for use and maintain optimal longevity
requires the use of interventional procedures. While radiocontrast use can lead to acute,
often reversible kidney injury, its use in AVF evaluation has renewed interest with the
recent implication of gadolinium-enhanced MRI being associated with a rare disorder of skin
swelling and induration called nephrogenic systemic fibrosis. CKD patients are particularly
susceptible to long term adverse outcomes from contrast-induced kidney injury, with 1 year
mortality in stage 4 and 5 CKD patients being 44% and 62%, respectively. While optimal fluid
therapy to prevent contrast-induced kidney injury remains uncertain, several prospective
randomized trials using sodium bicarbonate pretreatment have shown a lower incidence of
contrast-related kidney injury compared to isotonic saline. Traditional markers of acute
kidney injury, including serum creatinine, blood urea nitrogen, and creatinine clearance have
been insensitive in differentiating contrast-induced kidney injury from other forms of renal
injury. Kidney injury marker-1 (KIM-1) is a transmembrane receptor induced to very high
levels in the proximal tubule of the nephron following ischemic and nephrotoxic injury. KIM-1
has been shown in a small cohort of patients to differentiate ischemic kidney injury from
other forms of acute and chronic kidney disease.
Inclusion Criteria:
- English speaking
- >18 yrs age
- chronic kidney disease, documented GFR<30ml/min by abbreviated MDRD calculation
Exclusion Criteria:
- Inpatients
- Pediatric patients
- Non-English speaking patients
- established dialysis patients
- patients receiving iodinated contrast within 30 days of current procedure
- patients with central arterial manipulation within 30 days of current procedure
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