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Trial record 6 of 221 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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
Sponsor:
Information provided by (Responsible Party):
Li Yang, Peking University First Hospital

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.

Condition or disease
Acute Kidney Injury

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of acute kidney injury within 7 days after surgery [ Time Frame: within 7 days after surgery ]
    AKI is diagnosed according to KDIGO criteria


Secondary Outcome Measures :
  1. Severity of acute kidney injury within 7 days after surgery [ Time Frame: within 7 days after surgery ]
    AKI is classified according to KDIGO criteria

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
High risk patients undergoing non-cardiac surgery
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Shuangling Li, MD +861083575263 lishuangling888@hotmail.com
Contact: Nan Li, MD +861083572623 iculinan@163.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Shuangling Li    +861083575263    lishuangling888@hotmail.com   
Sponsors and Collaborators
Peking University First Hospital

Publications:

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Responsible Party: Li Yang, Principal Investigator, Clinical Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03880110     History of Changes
Other Study ID Numbers: Early predicting AKI
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Yang, Peking University First Hospital:
Acute Kidney Injury
Early prediction
Non cardiac surgery
Biomarker
Urine sedimentation
Renal resistive index

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases