Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03880110|
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 24, 2019
|Condition or disease|
|Acute Kidney Injury|
Early prediction of AKI have long been a study hotspot. Various clinical prediction models, biomarkers, urine sedimentation scores and imaging tools are developed and validated in different clinical settings mainly focusing on contrast associated AKI, durg induced AKI and cardiac surgery associated AKI. Due to the heterogenicity of this syndrome, one parameter which fits all patients for prediction of AKI dose not possibly exist. As a result, searching for combination parameters that can well predict AKI after non-cardiac surgery become the first priority for prevention of AKI. Evidence in non-cardiac surgery population have been gradually accumulated in recent years. Biomarkers for G1 cell cycle arrest, e.g. tissue inhibitor of metalloproteinase-2 (TIMP-2) and insulin like growth factor binding protein-7 (IGFBP-7), have demonstrated robust predictive performance in high risk surgical patients. Renal resistive index as calculated by ultrasound have also showed its validity in AKI prediction in patients following orthopedic surgery. Hence, the investigators make an assumption that combination of biomarkers, urine sedimentation and renal resistive index may improve the predictive value of AKI 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.
Adult patients undergoing non-cardiac surgery and then admitting to surgical intensive care unit (SICU) will be immediately screened for this study. 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. Meanwhile, central venous pressure (CVP) will be measured by primary nurse. If the patients were enrolled at daytime between 8:00-16:00, experienced intensivists will also calculate the renal resistive index (RI) by ultrasound. Urine samples will be collected again for storage after 6 and 12 hours admitting to SICU, at which time urine sedimentation and CVP will be repeatedly measured at the discretion of physician in-charge. AKI is monitored by serum creatinine daily in SICU and on demand in general wards, and by urine output (UO) every 3 hours in SICU. Patients will be followed up for postoperative complications, renal recovery, survival, SICU/in hospital stay and total cost until the first thing that happens: discharge/death, 30d after operation or withdrawing the study. Perioperative data will be recorded by specialized researchers.
|Study Type :||Observational|
|Estimated Enrollment :||660 participants|
|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|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||March 2020|
- Incidence of acute kidney injury within 7 days after surgery [ Time Frame: within 7 days after surgery ]AKI is diagnosed according to KDIGO criteria
- Severity of acute kidney injury within 7 days after surgery [ Time Frame: within 7 days after surgery ]AKI is classified according to KDIGO criteria
- Incidence of postoperative complications [ Time Frame: 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) ]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.
- Rate of ICU or in-hospital mortality [ Time Frame: 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) ]ICU/In-hospital mortality
- Rate of dialysis dependent at discharge [ Time Frame: Until the first thing that happens: discharge/death, 30 days after operation or withdrawing the study. ]Defined as requiring any modality of renal replacement therapy at discharge
- Rate of continuous decreased kidney function at discharge [ Time Frame: 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) ]Estimated glomerular filtration rate (eGFR) decreased more than 25% of baseline value at discharge
- Rate of major adverse kidney events (MAKE) [ Time Frame: 30 days after operation or withdrawing the study ( the first thing that happens: discharge/death) ]Defined as a composite of death, dialysis dependent or continuous decreased kidney function
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880110
|Contact: Shuangling Li, MDemail@example.com|
|Contact: Nan Li, MDfirstname.lastname@example.org|
|Peking University First Hospital||Recruiting|
|Beijing, Beijing, China, 010|
|Contact: Shuangling Li +861083575263 email@example.com|