Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01531985
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2012-02-09
Brief Title:
Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery for Congenital Heart Disease in Children and Adults A Pilot Study
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out whether a combination of new urine tests and blood tests can show kidney injury in its early stages before kidney failure sets in If the investigators find new tests that show kidney injury in early stages the investigators hope to start treating people with kidney injury earlier to prevent kidney failure Youyour child are at higher risk for kidney injury and kidney failure than most other people because of having operations with cardiopulmonary bypass a machine that pumps youryour childs blood during the operation This research is being done because there are no tests yet proven to show kidney injury before it leads to kidney failure
The urine and blood tests the investigators are studying have each been shown to indicate some degree of kidney injury in certain people but not with the accuracy needed to diagnose disease The investigators think that the combination of urine and blood tests being tried in this research study may provide enough information to better diagnose kidney injury at an earlier stage
About 20 persons over 2 years old up to adults will take part in this study All will be from the Herma Heart Center of Childrens Hospital of Wisconsin
The urine and blood tests the investigators are studying have each been shown to indicate some degree of kidney injury in certain people but not with the accuracy needed to diagnose disease The investigators think that the combination of urine and blood tests being tried in this research study may provide enough information to better diagnose kidney injury at an earlier stage
About 20 persons over 2 years old up to adults will take part in this study All will be from the Herma Heart Center of Childrens Hospital of Wisconsin
Detailed Description:
Purpose This will assess whether sensitive tests for urine or serum biomarkers are able to detect acute kidney injury following cardiopulmonary bypass surgery in the context of congenital heart disease
Background Acute kidney injury AKI is defined as an abrupt decrease in renal function resulting in retention of nitrogenous urea and creatinine and non-nitrogenous waste products AKI is a common complication following cardiopulmonary bypass CPB surgery occurring in up to 30 of adult patients following CPB surgery increasing morbidity mortality and resource utilization
Patients with cyanotic heart disease who undergo CPB surgery are also at risk of developing AKI These patients require multiple surgeries over the course of their lifetime to correct their congenital cardiac lesions Cyanosis alone causes a glomerulopathy characterized clinically by sub-nephrotic range proteinuria with higher prevalence related to length of time prior to initial corrective procedures
Pharmacological strategies for treatment of AKI have shown little efficacy in previous studies Thus recent studies have aimed to evaluate novel plasma and urinary biomarkers for early diagnosis of AKI based on the hypothesis that outcomes may improve if AKI were identified and treatment initiated earlier Urinary IL-18 and NGAL have been shown to be predictive markers of AKI after cardiopulmonary surgery in a pediatric population with a variety of congenital heart defects This ultimately reduced detection time from 40 hours with conventional serum creatinine assays to 4-6 hours with urinary IL-18 and NGAL Serum Cystatin C has also been shown to be as reliable as serum creatinine in predicting kidney filtration levels particularly for subjects with reduced muscle mass such as a population with congenital heart disease
However no study has evaluated the utility of such markers in a combined pediatric and adult congenital heart disease population These patients are unique because of the multitude of CPB surgeries required throughout their lifetime degree of life spent cyanotic and thus may differ in their susceptibility to cardiac surgery associated AKI
Our long term goal is to evaluate the value of urinary and serum biomarkers for early detection of AKI in this unique patient population Currently the investigators propose to perform a pilot study to evaluate the feasibility of the study methods and to obtain preliminary data to assist in power calculations for a larger study
Methods The investigators will enroll a total of 20 patients undergoing pulmonary valve replacement All patients will have a history of a conotruncal anomaly with previous corrective surgery requiring cardiopulmonary bypass Enrollment will occur at the time of cardiology or cardiovascular surgery consultation
After informed consent and assent is obtained urine and serum samples will be collected for the study protocol Urine specimens for creatinine NGAL and IL-18 will be collected pre-operatively for baseline measurement in addition to post-operatively at 6 12 24 and 72 hours Cystatin C will be measured pre-operatively to assess chronic renal function Serum creatinine will be measured pre-operatively and post-operatively at 12 hours and daily as part of usual clinical care
Patients will be followed for 7 days after surgery or until the day of hospital discharge whichever occurs first Data collected from the hospital chart will include demographics medical and surgical history type of surgical procedure underlying congenital heart disease baseline serum creatinine and renal function serum creatinines throughout hospitalization daily urine output need for dialysis date of death or discharge The primary endpoint is development of AKI based on serum creatinine reaching double baseline or requirement for acute dialysis as described in the RIFLE- Risk Injury Failure Loss and End Stage Renal Disease- model of renal insufficiency
Background Acute kidney injury AKI is defined as an abrupt decrease in renal function resulting in retention of nitrogenous urea and creatinine and non-nitrogenous waste products AKI is a common complication following cardiopulmonary bypass CPB surgery occurring in up to 30 of adult patients following CPB surgery increasing morbidity mortality and resource utilization
Patients with cyanotic heart disease who undergo CPB surgery are also at risk of developing AKI These patients require multiple surgeries over the course of their lifetime to correct their congenital cardiac lesions Cyanosis alone causes a glomerulopathy characterized clinically by sub-nephrotic range proteinuria with higher prevalence related to length of time prior to initial corrective procedures
Pharmacological strategies for treatment of AKI have shown little efficacy in previous studies Thus recent studies have aimed to evaluate novel plasma and urinary biomarkers for early diagnosis of AKI based on the hypothesis that outcomes may improve if AKI were identified and treatment initiated earlier Urinary IL-18 and NGAL have been shown to be predictive markers of AKI after cardiopulmonary surgery in a pediatric population with a variety of congenital heart defects This ultimately reduced detection time from 40 hours with conventional serum creatinine assays to 4-6 hours with urinary IL-18 and NGAL Serum Cystatin C has also been shown to be as reliable as serum creatinine in predicting kidney filtration levels particularly for subjects with reduced muscle mass such as a population with congenital heart disease
However no study has evaluated the utility of such markers in a combined pediatric and adult congenital heart disease population These patients are unique because of the multitude of CPB surgeries required throughout their lifetime degree of life spent cyanotic and thus may differ in their susceptibility to cardiac surgery associated AKI
Our long term goal is to evaluate the value of urinary and serum biomarkers for early detection of AKI in this unique patient population Currently the investigators propose to perform a pilot study to evaluate the feasibility of the study methods and to obtain preliminary data to assist in power calculations for a larger study
Methods The investigators will enroll a total of 20 patients undergoing pulmonary valve replacement All patients will have a history of a conotruncal anomaly with previous corrective surgery requiring cardiopulmonary bypass Enrollment will occur at the time of cardiology or cardiovascular surgery consultation
After informed consent and assent is obtained urine and serum samples will be collected for the study protocol Urine specimens for creatinine NGAL and IL-18 will be collected pre-operatively for baseline measurement in addition to post-operatively at 6 12 24 and 72 hours Cystatin C will be measured pre-operatively to assess chronic renal function Serum creatinine will be measured pre-operatively and post-operatively at 12 hours and daily as part of usual clinical care
Patients will be followed for 7 days after surgery or until the day of hospital discharge whichever occurs first Data collected from the hospital chart will include demographics medical and surgical history type of surgical procedure underlying congenital heart disease baseline serum creatinine and renal function serum creatinines throughout hospitalization daily urine output need for dialysis date of death or discharge The primary endpoint is development of AKI based on serum creatinine reaching double baseline or requirement for acute dialysis as described in the RIFLE- Risk Injury Failure Loss and End Stage Renal Disease- model of renal insufficiency
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