UF Health
Gainesville, Florida, 32610, United States
NCT Number: NCT02114138
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Gainesville, Florida, 32610, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery
urine collection will be performed on both the control group and hospitalized participants
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 6 months
Time-to-Event Outcome Measure taken when mechanical ventilation is greater than 48 hours during hospitalization.
Time frame: 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.
Time frame: up to 6 months
Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at hospital discharge.
Time frame: 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.
Time frame: 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.
University of Florida
Other
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)
Acronym: NavigateAKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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