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

• ClinicalTrials.gov Identifier: NCT02114138
• Recruitment Status: Active, not recruiting
• First Posted: April 15, 2014
• Last Update Posted: June 6, 2023
• Sponsor: University of Florida
• Collaborator: Heermann Anesthesia Foundation
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment
Acute Kidney Injury	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 Design

• Study Type: Observational
• Estimated Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 Start Date: July 2015
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: December 2025

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Occurrence of postoperative acute kidney injury (pAKI) [ 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.

Secondary Outcome Measures :

1. Change from baseline in urine protein biomarkers at 4 hours after surgery [ 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.
2. Change from baseline in urine protein biomarkers at postoperative day 1 [ 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

Other Outcome Measures:

1. All cause mortality [ 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.
2. Prolonged mechanical ventilation [ Time Frame: Up to 6 months ]
   Time-to-Event Outcome Measure taken when mechanical ventilation is greater than 48 hours during hospitalization.
3. chronic kidney disease (CKD) [ 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.
4. all cause mortality [ Time Frame: up to 6 months ]
   Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at hospital discharge.
5. all cause mortality [ 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.
6. chronic kidney disease (CKD) [ 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.

Biospecimen Retention:   Samples Without DNA

urine samples blood samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Locations

United States, Florida

UF Health

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Heermann Anesthesia Foundation

Investigators

• Principal Investigator: Azra Bihorac, MD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02114138
• Other Study ID Numbers: IRB201400127
• First Posted: April 15, 2014
• Last Update Posted: June 6, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:

postoperative acute kidney injury; pAKI; stress injury on the kidney; chronic kidney disease; CKD

Additional relevant MeSH terms:

Acute Kidney Injury; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases