The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of the PRESERVE trial was to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in high-risk participants scheduled to undergo coronary or non-coronary angiography.
The Biomarker Collection and Analysis sub-study collected, banked, and analyzed the blood and urine of participants from the VA-funded PRESERVE trial. Blood and urine proteins and other markers may predict the development of contrast-induced acute kidney injury and diagnose the very early stages of this condition following angiography. In addition, these biomarkers may predict which patients that develop acute kidney injury following angiography are likely to experience serious longer-term complications such as death, need for dialysis, and/or progressive loss of kidney function.
The aim of the Biomarker Collection and Analysis sub-study was to establish a biorepository of blood and urine samples from the PRESERVE trial participants to allow for future analyses of known and yet-to-be identified biomarkers that may predict and diagnose contrast-induced acute kidney injury.
The primary outcome included a composite of serious, adverse, patient-centered events, such as death, need for acute dialysis, and persistent decline in kidney function.
All sub-study participants were from the PRESERVE trial. Recruitment for the sub-study occurred when participants enrolled in the PRESERVE trial. No additional inclusion or exclusion criteria were applied for participation.
Pre-angiography measurements of plasma biomarkers and urine biomarkers modestly predicted the development of major adverse kidney events and death. Measurement of these injury and repair biomarkers can be used to improve the efficiency of future contrast-associated acute kidney injury trials.
Kidney Disease
Observational
33
2013-10
2017-10
Cardiovascular Disorder, Acute Kidney Injury
Renal Disease, Isotonic Bicarbonate, Acute Kidney Injury (AKI), Plasma Biomarkers, Urine Biomarkers, Undergo Coronary Angiography
Division of Kidney, Urologic, and Hematologic Diseases
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
---|---|---|---|---|
Serious Adverse Event MedDRA Codes Dataset | Captures serious adverse event data, including MedDRA codes | 1000 | sas7bdat (1.42 MB); csv (152.01 KB) | |
Additional or Replacement Study Drug Assignment Dataset | Captures additional or replacement study drug data | 619 | sas7bdat (792 KB); csv (67.38 KB) | |
5 Days Post Procedure Dataset | Captures 5 days post procedure data | 5354 | sas7bdat (832 KB); csv (334.39 KB) | |
35 Days Post Procedure Dataset | Captures 35 days post procedure data | 904 | sas7bdat (192 KB); csv (63.44 KB) | |
Pre Procedure Laboratory Values Dataset | Captures data on pre procedure laboratory test values | 924 | sas7bdat (320 KB); csv (163 KB) | |
Pre Procedure Non-Study Medications Dataset | Captures data on pre procedure non-study medications | 5845 | sas7bdat (768 KB); csv (249.46 KB) | |
Study IV Fluid Administration Dataset | Captures study IV fluid administrative data | 2332 | sas7bdat (512 KB); csv (161.84 KB) | |
Pre Procedure Non-Study IV Fluid Dataset | Captures pre procedure non-study IV fluid data | 924 | sas7bdat (640 KB); csv (185.88 KB) | |
Post Procedure Urine pH Results Datasets | Captures post procedure urine pH results data | 919 | sas7bdat (192 KB); csv (42.6 KB) | |
Early Participant Withdrawal Dataset | Captures data on early participant withdrawal | 41 | sas7bdat (128 KB); csv (4.14 KB) | |
Procedure Related Dataset | Contains procedure related data | 918 | sas7bdat (768 KB); csv (100.99 KB) | |
Adverse Event Dataset | Captures adverse event data | 103 | sas7bdat (1.23 MB); csv (41.93 KB) | |
Form 19 Adverse Event Dataset | Captures adverse event data from associated with Form 19 | 219 | sas7bdat (128 KB); csv (19.1 KB) | |
90 Days Post Procedure Dataset | Captures 90 days post procedure data | 889 | sas7bdat (192 KB); csv (52.95 KB) | |
Local Lab US CON Dataset | Captures local lab data | 14 | sas7bdat (208 KB); csv (2.4 KB) | |
Study Blood Specimens Dataset | Captures study blood specimens data | 2654 | sas7bdat (576 KB); csv (181.86 KB) | |
CSP578 Serious Adverse Event Follow-Up Dataset | Captures serious adverse event follow-up data | 30 | sas7bdat (512 KB); csv (9.34 KB) | |
Central Lab Dataset | Captures central lab results data | 912 | sas7bdat (640 KB); csv (149.75 KB) | |
Sub Protocol Dataset | Captures sub protocol data | 954 | sas7bdat (4.75 MB); csv (192.79 KB) | |
CSP578 ITT Dataset | Captures CSP578 data | 924 | sas7bdat (448 KB); csv (180.86 KB) | |
Initial Study Drug Assignment Dataset | Captures initial study drug assignment data | 924 | sas7bdat (192 KB); csv (48.82 KB) | |
Endpoint Serious Adverse Event Dataset | Captures endpoint serious adverse event data associated with Form 20 | 1010 | sas7bdat (2.13 MB); csv (449.14 KB) | |
Protocol Deviation Dataset | Captures data on protocol deviation | 914 | sas7bdat (1.12 MB); csv (198.63 KB) | |
Local Lab US Dataset | Captures local lab data | 7 | sas7bdat (368 KB); csv (1.76 KB) | |
12 Hours Post Procedure Dataset | Captures 12 hours post procedure data | 1832 | sas7bdat (1.19 MB); csv (117.72 KB) | |
Adverse Event MedDRA Codes Dataset | Captures adverse event data, including MedDRA codes | 103 | sas7bdat (312 KB); csv (15.51 KB) | |
Blood Pressure and Weight Dataset | Captures blood pressure and weight data | 924 | sas7bdat (320 KB); csv (64.06 KB) | |
NIDDK DB Final Dataset | Final NIDDK dataset | 21381 | sas7bdat (14.31 MB); csv (2.91 MB) | |
Serious Adverse Event Dataset | Captures serious adverse event data | 1000 | sas7bdat (21.92 MB); csv (762.23 KB) | |
Local Lab US BL Dataset | Captures local lab data | 5 | sas7bdat (128 KB); csv (146 B) | |
Hospitalizations Within 96 Hours Post Procedure Dataset | Captures data on hospitalizations within 96 hours post procedure | 956 | sas7bdat (512 KB); csv (59.47 KB) | |
Demographics Dataset | Captures demographics data | 924 | sas7bdat (320 KB); csv (63.36 KB) | |
Medical History Dataset | Captures medical history data | 924 | sas7bdat (192 KB); csv (51.56 KB) | |
US Local Dataset | Captures US local data | 14 | sas7bdat (128 KB); csv (630 B) | |
CF 13 Dataset | Captures CF 13 data | 919 | sas7bdat (1.32 MB); csv (54.91 KB) |
Specimen | Count |
---|---|
Plasma | 5145 |
Serum | 6810 |
Urine | 6534 |