Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery

NCT03880110 | Unknown

• 1 other identifier: Early predicting AKI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a common complication after non-cardiac surgery with adverse short and long term morbidity and mortality. So far there have been no effective therapy for AKI treatment developed, possibly due to the heterogenicity of this syndrome. Therefore, prevention of AKI in high risk patients undergoing non-cardiac surgery, as emphasized by Kidney Disease Improving Global Outcomes (KDIGO), becomes the first priority. However, early prediction of AKI is the first step before taking preventive measures, which really make a great challenge to clinical practitioners because of such a limited time window and complex clinical scenarios. Recently, cumulative evidence have shown that biomarkers and renal ultrasound may play an important role in AKI prediction after non-cardiac surgery. The purpose of this study is to investigate the combination of biomarkers, urine sedimentation and renal resistive index for early prediction of AKI in high risk patients undergoing non-cardiac surgery.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Early prediction; Non cardiac surgery; Biomarker; Urine sedimentation; Renal resistive index

Outcome Measures

Primary Outcomes (1)

• Incidence of acute kidney injury within 7 days after surgery

  AKI is diagnosed according to KDIGO criteria

  within 7 days after surgery

Secondary Outcomes (6)

• Severity of acute kidney injury within 7 days after surgery

  within 7 days after surgery

• Incidence of postoperative complications

  30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)

• Rate of ICU or in-hospital mortality

  30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)

• Rate of dialysis dependent at discharge

  Until the first thing that happens: discharge/death, 30 days after operation or withdrawing the study.

• Rate of continuous decreased kidney function at discharge

  30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High risk patients undergoing non-cardiac surgery

You may qualify if:

• Age ≥ 18 years; Undergoing non-cardiac surgery; Admitted to SICU immediately after surgery

You may not qualify if:

• Chronic kidney disease stage 5 (CKD-5) or requiring long-term dialysis; Undergoing kidney-related surgery; AKI before admission to SICU; Without Foley catheter placement ;Written informed consent not obtained

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Related Publications (12)

• Grams ME, Sang Y, Coresh J, Ballew S, Matsushita K, Molnar MZ, Szabo Z, Kalantar-Zadeh K, Kovesdy CP. Acute Kidney Injury After Major Surgery: A Retrospective Analysis of Veterans Health Administration Data. Am J Kidney Dis. 2016 Jun;67(6):872-80. doi: 10.1053/j.ajkd.2015.07.022. Epub 2015 Sep 1.

  PMID: 26337133 BACKGROUND

• Kashani K, Cheungpasitporn W, Ronco C. Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption. Clin Chem Lab Med. 2017 Jul 26;55(8):1074-1089. doi: 10.1515/cclm-2016-0973.

  PMID: 28076311 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

• Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.

  PMID: 24559465 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

• Gunnerson KJ, Shaw AD, Chawla LS, Bihorac A, Al-Khafaji A, Kashani K, Lissauer M, Shi J, Walker MG, Kellum JA; Sapphire Topaz investigators. TIMP2*IGFBP7 biomarker panel accurately predicts acute kidney injury in high-risk surgical patients. J Trauma Acute Care Surg. 2016 Feb;80(2):243-9. doi: 10.1097/TA.0000000000000912.

  PMID: 26816218 BACKGROUND

• Perazella MA. The urine sediment as a biomarker of kidney disease. Am J Kidney Dis. 2015 Nov;66(5):748-55. doi: 10.1053/j.ajkd.2015.02.342. Epub 2015 May 2.

  PMID: 25943719 BACKGROUND

• Becker GJ, Garigali G, Fogazzi GB. Advances in Urine Microscopy. Am J Kidney Dis. 2016 Jun;67(6):954-64. doi: 10.1053/j.ajkd.2015.11.011. Epub 2016 Jan 22.

  PMID: 26806004 BACKGROUND

• Marty P, Ferre F, Labaste F, Jacques L, Luzi A, Conil JM, Silva S, Minville V. The Doppler renal resistive index for early detection of acute kidney injury after hip fracture. Anaesth Crit Care Pain Med. 2016 Dec;35(6):377-382. doi: 10.1016/j.accpm.2015.12.013. Epub 2016 Apr 28.

  PMID: 27133237 BACKGROUND

• Marty P, Szatjnic S, Ferre F, Conil JM, Mayeur N, Fourcade O, Silva S, Minville V. Doppler renal resistive index for early detection of acute kidney injury after major orthopaedic surgery: a prospective observational study. Eur J Anaesthesiol. 2015 Jan;32(1):37-43. doi: 10.1097/EJA.0000000000000120.

  PMID: 25014511 BACKGROUND

• Li N, Wang J, Zhou W, Li S, Yang L. External Validation of the Simple Postoperative Acute Kidney Injury Risk Index in Patients Admitted to the Intensive Care Unit After Noncardiac Surgery. Anesth Analg. 2025 May 1;140(5):1140-1148. doi: 10.1213/ANE.0000000000007320.

  PMID: 39919018 DERIVED

• Li N, Zhou WJ, Chi DX, Yuan C, Xie M, Li Z, Wang R, Qu CX, Li XY, Li SL, Yang L. Association between urine microscopy and severe acute kidney injury in critically ill patients following non-cardiac surgery: a prospective cohort study. Ann Palliat Med. 2022 Jul;11(7):2327-2337. doi: 10.21037/apm-21-3085. Epub 2022 May 19.

  PMID: 35610195 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

After enrollment, blood and urine samples, in addition to clinical routine tests, will be collected for the tests of biomarkers and urine sedimentation, such as serum creatinine, TIMP-2, IGFBP-7, α-1 microglobulin, microalbumin, transferrin, granular cast and so on. Urine samples will be collected again for storage after 6 and 12 hours admitting to SICU, at which time urine sedimentation will be repeatedly measured at the discretion of physician in-charge.

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

Central Study Contacts

Shuangling Li, MD

CONTACT

+861083575263; lishuangling888@hotmail.com

Nan Li, MD

CONTACT

+861083572623; iculinan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: May 20, 2019
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)