Acute Kidney Injury
Conditions
Keywords
postoperative acute kidney injury, pAKI, stress injury on the kidney, chronic kidney disease, CKD
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.
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.
Interventions
PROCEDUREpathogenesis of perioperative acute kidney injury
understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery
DIAGNOSTIC_TESTurine collection
urine collection will be performed on both the control group and hospitalized participants
Sponsors
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | 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. |
Countries
United States
Outcome results
None listed