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

University of Florida

Status: Active, not recruiting

Conditions: Acute Kidney Injury

Treatments: Procedure: pathogenesis of perioperative acute kidney injury; Diagnostic Test: urine collection

Study type: Observational

Funder types: Other

Identifiers

NCT02114138

IRB201400127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

240 participants in 2 patient groups

Surgical Group

Description:

Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection

Treatment:

Diagnostic Test: urine collection

Procedure: pathogenesis of perioperative acute kidney injury

Healthy Control

Description:

Healthy Adult volunteers who are willing to provide a 200 ml urine sample.

Treatment:

Diagnostic Test: urine collection