NavigateAKI: Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgical Group Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection |
Procedure: pathogenesis of perioperative acute kidney injury
understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery
Diagnostic Test: urine collection
urine collection will be performed on both the control group and hospitalized participants
|
| Healthy Control Healthy Adult volunteers who are willing to provide a 200 ml urine sample. |
Diagnostic Test: urine collection
urine collection will be performed on both the control group and hospitalized participants
|
Outcome Measures
Primary Outcome Measures
- Occurrence of postoperative acute kidney injury (pAKI) [up to 7 days after surgery.]
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.
Secondary Outcome Measures
- Change from baseline in urine protein biomarkers at 4 hours after surgery [Baseline, 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.
- Change from baseline in urine protein biomarkers at postoperative day 1 [Baseline, day 1 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 postoperative day 1
Other Outcome Measures
- All cause mortality [12 months post-discharge from the hospital.]
Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 12 months post-discharge from the hospital.
- Prolonged mechanical ventilation [Up to 6 months]
Time-to-Event Outcome Measure taken when mechanical ventilation is greater than 48 hours during hospitalization.
- chronic kidney disease (CKD) [12 months post-discharge from the hospital.]
This outcome will be assessed using urinary microalbumin/creatinine ratio (dipstick) mailed to study participants to urinate on and send back to the study team in provided shipping material at 12 months post-discharge from the hospital.
- all cause mortality [up to 6 months]
Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at hospital discharge.
- all cause mortality [6 months post-discharge from the hospital.]
Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 6 months post-discharge from the hospital.
- chronic kidney disease (CKD) [6 months post-discharge from the hospital.]
This outcome will be assessed using urinary microalbumin/creatinine ratio (dipstick) mailed to study participants to urinate on and send back to the study team in provided shipping material at 6 months post-discharge from the hospital.
Eligibility Criteria
Criteria
Inclusion Criteria for Surgical Group:
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Patients undergoing major in-hospital surgery
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Planned hospital stay of at least 24 hours
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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:
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Stroke/Transient Ischemic Attack
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Heart Attack
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Major Thoracic, abdominal, or Vascular surgery
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Radiation Therapy
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Chemo Therapy
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Immunosuppressive Therapy
IV contrast within the past 72 hours
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UF Health | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
- Heermann Anesthesia Foundation
Investigators
- Principal Investigator: Azra Bihorac, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB201400127