Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury (NavigateAKI)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Procedure: pathogenesis of perioperative acute kidney injury; Diagnostic test: urine collection

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Heermann Anesthesia Foundation
• Investigators: Principal Investigator: Azra Bihorac, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimated): April 15, 2014

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: chronic kidney disease; CKD; postoperative acute kidney injury; pAKI; stress injury on the kidney
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: IRB201400127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No