Clinical trial NCT02553174: AKI in Thoracic and Abdominal Surgery
Official title: Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified by surgeon and by length of procedure. Patients presenting to the Anesthesia Preoperative Clinic who are scheduled to have surgery lasting longer than 4 hours by certain surgeons, and who are anticipated to recover postoperatively in the Surgical Intensive Care Unit will be given a recruitment/consent form explaining the study. The study will then be explained to potential patients by a member of the research team to determine recruitment eligibility and willingness to participate.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 72 hours post-operatively
Secondary outcomes:
measure: Urine biomarkers in AKI detection
timeFrame: 72 hours post-operatively
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Anthony Bonavia, MD
role: PRINCIPAL_INVESTIGATOR
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