AKI in Thoracic and Abdominal Surgery

NCT02553174 | Terminated

• 1 other identifier: STUDY00003086
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  AKI defined by change in serum creatinine from baseline and change in urine output (KDIGO criteria)

  72 hours post-operatively

Secondary Outcomes (1)

• Urine biomarkers in AKI detection

  72 hours post-operatively

Study Arms (3)

Ketorolac

Patients who receive ketorolac perioperatively

Caldolor

Patients who receive Caldolor perioperatively

No NSAIDS

Patients who do not receive NSAIDS perioperatively

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (20)

• 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.

  PMID: 24764522 BACKGROUND

• 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.

  PMID: 21975865 BACKGROUND

• 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.

  PMID: 23394211 BACKGROUND

• 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.

  PMID: 15312219 BACKGROUND

• 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.

  PMID: 25005361 BACKGROUND

• 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.

  PMID: 23388612 BACKGROUND

• 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.

  PMID: 7910173 BACKGROUND

• 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.

  PMID: 19428114 BACKGROUND

• 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.

  PMID: 16707563 BACKGROUND

• 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.

  PMID: 17942417 BACKGROUND

• 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.

  PMID: 15276197 BACKGROUND

• 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.

  PMID: 24675717 BACKGROUND

• 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.

  PMID: 25798585 BACKGROUND

• 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.

  PMID: 19585463 BACKGROUND

• 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.

  PMID: 447795 BACKGROUND

• 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.

  PMID: 15754275 BACKGROUND

• 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.

  PMID: 3306093 BACKGROUND

• 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.

  PMID: 17391598 BACKGROUND

• 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.

  PMID: 11883386 BACKGROUND

• 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.

  PMID: 25125308 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Anthony Bonavia, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: June 1, 2016
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)