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

NCT ID: NCT02114138

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2030-12-31

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical Group

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

pathogenesis of perioperative acute kidney injury

Intervention Type: PROCEDURE

understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery

urine collection

Intervention Type: DIAGNOSTIC_TEST

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.

urine collection

Intervention Type: DIAGNOSTIC_TEST

urine collection will be performed on both the control group and hospitalized participants

Interventions

pathogenesis of perioperative acute kidney injury

understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery

Intervention Type: PROCEDURE

urine collection

urine collection will be performed on both the control group and hospitalized participants

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients undergoing major in-hospital surgery
• Planned hospital stay of at least 24 hours
• Able to enroll prior to undergoing surgery

> 18 years old that elect to serve as a control group

Exclusion Criteria

• Patients not recruited 4 hours prior to undergoing surgery

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Azra Bihorac, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201400127

Identifier Type: -

Identifier Source: org_study_id