AKI in Thoracic and Abdominal Surgery
Status: | Terminated |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/17/2018 |
Start Date: | June 1, 2016 |
End Date: | March 23, 2018 |
Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery
The study will investigate the role of NSAIDs in the development of AKI in patients
undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the
use of new urinary biomarkers will allow earlier detection of AKI than the current gold
standard, i.e. changes in serum creatinine and/or urine output.
undergoing high-risk abdominal or thoracic surgery. The investigators hypothesize that the
use of new urinary biomarkers will allow earlier detection of AKI than the current gold
standard, i.e. changes in serum creatinine and/or urine output.
This study will be designed as a prospective observational trial. After obtaining
Institutional Review Board (IRB) approval, patients will be recruited and consented from the
Anesthesia Pre-Operative Clinic. On the day of surgery, baseline urine samples will be
obtained at the initial insertion of the Foley catheter, after induction of anesthesia. Urine
samples will also be collected from the Foley catheter in the immediate post-operative period
shortly after the patient is admitted to the Intensive Care Unit (ICU). Urine samples will
continue to be collected for 72 hours post-operatively, at 0600 (6am) and 1800 (6pm) each day
from the indwelling Foley catheter, which is standard of care in the ICU. Urine samples will
be labeled and stored as per the instructions provided in a commercially available kit; six
urine samples total will be collected and stored per patient. The electronic medical record
(EMR) will be reviewed to determine whether the patient received ketorolac, ibuprofen, or no
NSAIDs intra-operatively and postoperatively (within 72 hours of the beginning of surgery).
Daily serum creatinine measurements and hourly urine output, which are standards of care in
the ICU, will be obtained from the EMR as well.
AKI will be diagnosed and staged according to KDIGO criteria, which are based on changes in
creatinine and urine output. In all patients with "KDIGO-diagnosed AKI" and in a matched
non-AKI group, we will also compare the time course of new urinary biomarkers, including but
not limited to uNGAL, to that of serum creatinine and urine output. We will match patients
according to their demographics as well as clinical characteristics, including
co-morbidities, type of surgery and anesthesia technique. Comparing the time course of
current clinical markers (serum creatinine and urine output) with that of new urinary
biomarkers will allow us to assess their role in guiding future preventive interventions.
Institutional Review Board (IRB) approval, patients will be recruited and consented from the
Anesthesia Pre-Operative Clinic. On the day of surgery, baseline urine samples will be
obtained at the initial insertion of the Foley catheter, after induction of anesthesia. Urine
samples will also be collected from the Foley catheter in the immediate post-operative period
shortly after the patient is admitted to the Intensive Care Unit (ICU). Urine samples will
continue to be collected for 72 hours post-operatively, at 0600 (6am) and 1800 (6pm) each day
from the indwelling Foley catheter, which is standard of care in the ICU. Urine samples will
be labeled and stored as per the instructions provided in a commercially available kit; six
urine samples total will be collected and stored per patient. The electronic medical record
(EMR) will be reviewed to determine whether the patient received ketorolac, ibuprofen, or no
NSAIDs intra-operatively and postoperatively (within 72 hours of the beginning of surgery).
Daily serum creatinine measurements and hourly urine output, which are standards of care in
the ICU, will be obtained from the EMR as well.
AKI will be diagnosed and staged according to KDIGO criteria, which are based on changes in
creatinine and urine output. In all patients with "KDIGO-diagnosed AKI" and in a matched
non-AKI group, we will also compare the time course of new urinary biomarkers, including but
not limited to uNGAL, to that of serum creatinine and urine output. We will match patients
according to their demographics as well as clinical characteristics, including
co-morbidities, type of surgery and anesthesia technique. Comparing the time course of
current clinical markers (serum creatinine and urine output) with that of new urinary
biomarkers will allow us to assess their role in guiding future preventive interventions.
Inclusion Criteria:
- age ≥ 21 (per manufacturer's instructions on the Nephrocheck kit)
- history of hypertension, whether medically treated or untreated
- scheduled for Anesthesia preoperative clinic visit
- scheduled to undergo prolonged intra-abdominal or intra-thoracic surgeries (defined as
scheduled intraoperative time ≥ 4h). Intra-abdominal surgeries will include colorectal
surgery, massive ventral hernia repairs, hepatobiliary surgery and
gynecologic-oncology surgery. Intra-thoracic surgeries will include video-assisted
thoracoscopic surgery (VATS)-assisted segmentectomy and lobectomies, as well as
mediastinal mass excisions.
- will be anticipated to be admitted to the ICU for a minimum of 2-3 days
post-operatively
Exclusion Criteria:
- history of chronic kidney as defined by estimated glomerular filtration rate (GFR) <90
- patient taking NSAIDs on a daily basis
- patients with a reported allergy or intolerance to NSAIDs
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
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