AKI in Thoracic and Abdominal Surgery

Acute Kidney Injury and Nonsteroidal Anti-inflammatory Drugs in Patients Undergoing High-risk Abdominal or Thoracic Surgery


Lead Sponsor: Milton S. Hershey Medical Center

Source Milton S. Hershey Medical Center
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.

Overall Status Terminated
Start Date June 1, 2016
Completion Date March 23, 2018
Primary Completion Date March 23, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Acute Kidney Injury 72 hours post-operatively
Secondary Outcome
Measure Time Frame
Urine biomarkers in AKI detection 72 hours post-operatively
Enrollment 50

Sampling Method: Non-Probability Sample


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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anthony Bonavia, MD Principal Investigator Milton S. Hershey Medical Center
Facility: Penn State Milton S Hershey Medical Center
Location Countries

United States

Verification Date

March 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Milton S. Hershey Medical Center

Investigator Full Name: Anthony Bonavia

Investigator Title: Assistant Professor of Anesthesiology

Has Expanded Access No
Condition Browse
Arm Group

Label: Ketorolac

Description: Patients who receive ketorolac perioperatively

Label: Caldolor

Description: Patients who receive Caldolor perioperatively

Label: No NSAIDS

Description: Patients who do not receive NSAIDS perioperatively

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov