Clinical trial NCT02114138: Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Keywords: postoperative acute kidney injury
pAKI
stress injury on the kidney
chronic kidney disease
CKD
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from which the cohort will be selected among patients undergoing major in-hospital surgery. Healthy Adult Volunteers who meet our enrollment criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of postoperative acute kidney injury (pAKI)
timeFrame: up to 7 days after surgery.
Secondary outcomes:
measure: Change from baseline in urine protein biomarkers at 4 hours after surgery
timeFrame: Baseline, 4 hours after surgery
measure: Change from baseline in urine protein biomarkers at postoperative day 1
timeFrame: Baseline, day 1 after surgery
Other outcomes:
measure: All cause mortality
timeFrame: 12 months post-discharge from the hospital.
measure: Prolonged mechanical ventilation
timeFrame: Up to 6 months
measure: chronic kidney disease (CKD)
timeFrame: 12 months post-discharge from the hospital.
measure: all cause mortality
timeFrame: up to 6 months
measure: all cause mortality
timeFrame: 6 months post-discharge from the hospital.
measure: chronic kidney disease (CKD)
timeFrame: 6 months post-discharge from the hospital.
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Azra Bihorac, MD
role: PRINCIPAL_INVESTIGATOR
References: