Acute Kidney Injury Clinical Trial
Official title:
Combination of Biomarkers, Urine Sedimentation and Renal Resistive Index for Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery: a Prospective Observational Cohort Study
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | November 30, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years; Undergoing non-cardiac surgery; Admitted to SICU immediately after surgery Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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, Rimmelé 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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of acute kidney injury within 7 days after surgery | AKI is diagnosed according to KDIGO criteria | within 7 days after surgery | |
Secondary | Severity of acute kidney injury within 7 days after surgery | AKI is classified according to KDIGO criteria | within 7 days after surgery | |
Secondary | Incidence of postoperative complications | Defined as newly onset medical conditions that are harmful to patients' recovery and required therapeutic intervention, including pulmonary infection, pleural effusion, atelectasis, respiratory failure, surgical bleeding, new onset arrhythmia, acute myocardial infarction, congestive heart failure, stroke, ileus, liver injury, digestive tract bleeding, wound infection, urinary tract infection, severe sepsis, acute kidney injury, pulmonary embolism and deep venous thrombosis. | 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) | |
Secondary | Rate of ICU or in-hospital mortality | ICU/In-hospital mortality | 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) | |
Secondary | Rate of dialysis dependent at discharge | Defined as requiring any modality of renal replacement therapy at discharge | Until the first thing that happens: discharge/death, 30 days after operation or withdrawing the study. | |
Secondary | Rate of continuous decreased kidney function at discharge | Estimated glomerular filtration rate (eGFR) decreased more than 25% of baseline value at discharge | 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) | |
Secondary | Rate of major adverse kidney events (MAKE) | Defined as a composite of death, dialysis dependent or continuous decreased kidney function | 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05538351 -
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03938038 -
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
|
N/A | |
Recruiting |
NCT05805709 -
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
|
N/A | |
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
Recruiting |
NCT05897840 -
Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
|
N/A | |
Recruiting |
NCT04986137 -
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
|
||
Terminated |
NCT04293744 -
Acute Kidney Injury After Cardiac Surgery
|
N/A | |
Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
Not yet recruiting |
NCT06026592 -
Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
|
||
Not yet recruiting |
NCT06064305 -
Transcriptional and Proteomic Analysis of Acute Kidney Injury
|
||
Terminated |
NCT03438877 -
Intensive Versus Regular Dosage For PD In AKI.
|
N/A | |
Terminated |
NCT03305549 -
Recovery After Dialysis-Requiring Acute Kidney Injury
|
N/A | |
Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Terminated |
NCT02860130 -
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
|
Phase 3 | |
Completed |
NCT06000098 -
Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
|
||
Not yet recruiting |
NCT05548725 -
Relation Between Acute Kidney Injury and Mineral Bone Disease
|
||
Completed |
NCT02665377 -
Prevention of Akute Kidney Injury, Hearttransplant, ANP
|
Phase 3 | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A |