AKI in Thoracic and Abdominal Surgery

March 29, 2018 updated by: Anthony Bonavia, Milton S. Hershey Medical Center

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ketorolac
Patients who receive ketorolac perioperatively
Caldolor
Patients who receive Caldolor perioperatively
No NSAIDS
Patients who do not receive NSAIDS perioperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury
Time Frame: 72 hours post-operatively
AKI defined by change in serum creatinine from baseline and change in urine output (KDIGO criteria)
72 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine biomarkers in AKI detection
Time Frame: 72 hours post-operatively
Our secondary analysis will investigate the performance of new FDA approved urine biomarkers including, but not limited to, uNGAL (urinary neutrophil gelatinase associated lipocalin) in AKI detection.
72 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Anthony Bonavia, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

March 23, 2018

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe