Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury

Study Overview
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Brief Summary
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The risk for postoperative acute kidney injury (pAKI), as for any other postoperative complications (PC), comes from a number of interactions between a patient's health before surgery, strength to tolerate surgery and influences on the operating room environment. At this time doctors do not have good tools to predict which patients may be at risk of having this complication. The purpose of this research study is to develop a urine test that can be used to predict the risk for having problems with kidney function after major surgery.

Detailed Description
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During hospitalization, a urine sample will be collected and additional tests will be added to the daily standard of care blood samples before, during and three times following an elective surgical procedure. Study participants will complete telephone interviews at 6 and 12 months after discharge from the hospital with a study team member. The telephone interview will consist of a short questionnaire asking about state of health and a health survey. At the same times of the phone interviews, the study team will mail a urine dipstick that is used to detect any amount of protein in the urine. Study participants will be asked to urinate on dipstick and send it back to the study team in provided shipping material. Healthy Controls will be enrolled to establish baseline values for kidney health based upon a single urine collection and a brief health questionnaire.

Official Title
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Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury Subtitle: Urinary Molecular and Metabolic Signature of Postoperative Acute Kidney Injury (NavigateAKI)

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Procedure: pathogenesis of perioperative acute kidney injury
* Diagnostic Test: urine collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Surgical Group: Patients undergoing major in-hospital surgery Planned hospital stay of at least 24 hours Able to enroll prior to undergoing surgery Exclusion Criteria for Surgical Group: Patients not recruited 4 hours prior to undergoing surgery Inclusion Criteria for Healthy volunteers: > 18 years old that elect to serve as a control group Exclusion Criteria for Healthy volunteers: Renal Replacement Therapy AKI/CKD Nephrectomy Organ transplant Any of the following within the last 12 months: Stroke/Transient Ischemic Attack Heart Attack Major Thoracic, abdominal, or Vascular surgery Radiation Therapy Chemo Therapy Immunosuppressive Therapy IV contrast within the past 72 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical Group<br>Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection | Procedure: pathogenesis of perioperative acute kidney injury<br>* understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery<br>Diagnostic Test: urine collection<br>* urine collection will be performed on both the control group and hospitalized participants<br>|
| Healthy Control<br>Healthy Adult volunteers who are willing to provide a 200 ml urine sample. | Diagnostic Test: urine collection<br>* urine collection will be performed on both the control group and hospitalized participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of postoperative acute kidney injury (pAKI) | PostoperativeAKI is a change outcome of an increase of greater than or equal to 50% of creatinine from initial level prior to surgery until postoperative day 7. | up to 7 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine protein biomarkers at 4 hours after surgery | Change in urine protein biomarkers (urine insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2)) from prior to surgery (baseline) to four hours after surgery. | Baseline, 4 hours after surgery | 
| Change from baseline in urine protein biomarkers at postoperative day 1 | Change in urine protein biomarkers (urine insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2)) from prior to surgery (baseline) to postoperative day 1 | Baseline, day 1 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative acute kidney injury, pAKI, stress injury on the kidney, chronic kidney disease, CKD