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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Group | Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection |
| |
| Healthy Control | Healthy Adult volunteers who are willing to provide a 200 ml urine sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pathogenesis of perioperative acute kidney injury | Procedure | understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery |
|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 12 months post-discharge from the hospital. | 12 months post-discharge from the hospital. |
| Prolonged mechanical ventilation |
Inclusion Criteria for Surgical Group:
Exclusion Criteria for Surgical Group:
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:
IV contrast within the past 72 hours
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The population from which the cohort will be selected among patients undergoing major in-hospital surgery. Healthy Adult Volunteers who meet our enrollment criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Azra Bihorac, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
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urine samples blood samples
| urine collection | Diagnostic Test | urine collection will be performed on both the control group and hospitalized participants |
|
| 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 |
Time-to-Event Outcome Measure taken when mechanical ventilation is greater than 48 hours during hospitalization.
| Up to 6 months |
| chronic kidney disease (CKD) | 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. | 12 months post-discharge from the hospital. |
| all cause mortality | Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at hospital discharge. | up to 6 months |
| all cause mortality | Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 6 months post-discharge from the hospital. | 6 months post-discharge from the hospital. |
| chronic kidney disease (CKD) | 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. | 6 months post-discharge from the hospital. |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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