AKI in Thoracic and Abdominal Surgery

NCT ID: NCT02553174

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-03-23

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ketorolac

Patients who receive ketorolac perioperatively

No interventions assigned to this group

Caldolor

Patients who receive Caldolor perioperatively

No interventions assigned to this group

No NSAIDS

Patients who do not receive NSAIDS perioperatively

No interventions assigned to this group

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Anthony Bonavia

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Bonavia, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

Calvert S, Shaw A. Perioperative acute kidney injury. Perioper Med (Lond). 2012 Jul 4;1:6. doi: 10.1186/2047-0525-1-6. eCollection 2012.

Reference Type: BACKGROUND

PMID: 24764522 (View on PubMed)

Singbartl K, Kellum JA. AKI in the ICU: definition, epidemiology, risk stratification, and outcomes. Kidney Int. 2012 May;81(9):819-25. doi: 10.1038/ki.2011.339. Epub 2011 Oct 5.

Reference Type: BACKGROUND

PMID: 21975865 (View on PubMed)

Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.

Reference Type: BACKGROUND

PMID: 23394211 (View on PubMed)

Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

Reference Type: BACKGROUND

PMID: 15312219 (View on PubMed)

Luo X, Jiang L, Du B, Wen Y, Wang M, Xi X; Beijing Acute Kidney Injury Trial (BAKIT) workgroup. A comparison of different diagnostic criteria of acute kidney injury in critically ill patients. Crit Care. 2014 Jul 8;18(4):R144. doi: 10.1186/cc13977.

Reference Type: BACKGROUND

PMID: 25005361 (View on PubMed)

Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.

Reference Type: BACKGROUND

PMID: 23388612 (View on PubMed)

Witzgall R, Brown D, Schwarz C, Bonventre JV. Localization of proliferating cell nuclear antigen, vimentin, c-Fos, and clusterin in the postischemic kidney. Evidence for a heterogenous genetic response among nephron segments, and a large pool of mitotically active and dedifferentiated cells. J Clin Invest. 1994 May;93(5):2175-88. doi: 10.1172/JCI117214.

Reference Type: BACKGROUND

PMID: 7910173 (View on PubMed)

Yang QH, Liu DW, Long Y, Liu HZ, Chai WZ, Wang XT. Acute renal failure during sepsis: potential role of cell cycle regulation. J Infect. 2009 Jun;58(6):459-64. doi: 10.1016/j.jinf.2009.04.003. Epub 2009 Apr 17.

Reference Type: BACKGROUND

PMID: 19428114 (View on PubMed)

Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006 Jun;17(6):1503-20. doi: 10.1681/ASN.2006010017. Epub 2006 May 17. No abstract available.

Reference Type: BACKGROUND

PMID: 16707563 (View on PubMed)

Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35(22):7475-84. doi: 10.1093/nar/gkm744. Epub 2007 Oct 16.

Reference Type: BACKGROUND

PMID: 17942417 (View on PubMed)

Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004 Aug 4;337:1-13. doi: 10.1016/j.gene.2004.04.032.

Reference Type: BACKGROUND

PMID: 15276197 (View on PubMed)

Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24675717 (View on PubMed)

Gocze I, Koch M, Renner P, Zeman F, Graf BM, Dahlke MH, Nerlich M, Schlitt HJ, Kellum JA, Bein T. Urinary biomarkers TIMP-2 and IGFBP7 early predict acute kidney injury after major surgery. PLoS One. 2015 Mar 23;10(3):e0120863. doi: 10.1371/journal.pone.0120863. eCollection 2015.

Reference Type: BACKGROUND

PMID: 25798585 (View on PubMed)

Lafrance JP, Miller DR. Selective and non-selective non-steroidal anti-inflammatory drugs and the risk of acute kidney injury. Pharmacoepidemiol Drug Saf. 2009 Oct;18(10):923-31. doi: 10.1002/pds.1798.

Reference Type: BACKGROUND

PMID: 19585463 (View on PubMed)

Zipser RD, Hoefs JC, Speckart PF, Zia PK, Horton R. Prostaglandins: modulators of renal function and pressor resistance in chronic liver disease. J Clin Endocrinol Metab. 1979 Jun;48(6):895-900. doi: 10.1210/jcem-48-6-895.

Reference Type: BACKGROUND

PMID: 447795 (View on PubMed)

Huerta C, Castellsague J, Varas-Lorenzo C, Garcia Rodriguez LA. Nonsteroidal anti-inflammatory drugs and risk of ARF in the general population. Am J Kidney Dis. 2005 Mar;45(3):531-9. doi: 10.1053/j.ajkd.2004.12.005.

Reference Type: BACKGROUND

PMID: 15754275 (View on PubMed)

Patrono C, Dunn MJ. The clinical significance of inhibition of renal prostaglandin synthesis. Kidney Int. 1987 Jul;32(1):1-12. doi: 10.1038/ki.1987.164. No abstract available.

Reference Type: BACKGROUND

PMID: 3306093 (View on PubMed)

Arora S, Wagner JG, Herbert M. Myth: parenteral ketorolac provides more effective analgesia than oral ibuprofen. CJEM. 2007 Jan;9(1):30-2. doi: 10.1017/s1481803500014718. No abstract available.

Reference Type: BACKGROUND

PMID: 17391598 (View on PubMed)

Forrest JB, Camu F, Greer IA, Kehlet H, Abdalla M, Bonnet F, Ebrahim S, Escolar G, Jage J, Pocock S, Velo G, Langman MJ, Bianchi PG, Samama MM, Heitlinger E; POINT Investigators. Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. Br J Anaesth. 2002 Feb;88(2):227-33. doi: 10.1093/bja/88.2.227.

Reference Type: BACKGROUND

PMID: 11883386 (View on PubMed)

Zarbock A, Meersch M, Van Aken H, Gorlich D, Singbartl K. Urinary hyaluronic acid as an early predictor of acute kidney injury after cardiac surgery. J Am Coll Cardiol. 2014 Aug 19;64(7):737-8. doi: 10.1016/j.jacc.2014.05.034. No abstract available.

Reference Type: BACKGROUND

PMID: 25125308 (View on PubMed)

Other Identifiers

STUDY00003086

Identifier Type: -

Identifier Source: org_study_id