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

NCT02114138 | Active Not Recruiting

• 1 other identifier: IRB201400127
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in urine protein biomarkers at 4 hours after surgery

  Baseline, 4 hours after surgery

• Change from baseline in urine protein biomarkers at postoperative day 1

  Baseline, day 1 after surgery

Other Outcomes (6)

• All cause mortality

  12 months post-discharge from the hospital.

• Prolonged mechanical ventilation

  Up to 6 months

• chronic kidney disease (CKD)

  12 months post-discharge from the hospital.

Study Arms (2)

Surgical Group

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

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

Healthy Control

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

Diagnostic Test: urine collection

Interventions

pathogenesis of perioperative acute kidney injury PROCEDURE

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

Surgical Group

urine collection DIAGNOSTIC_TEST

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

Healthy Control; Surgical Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients not recruited 4 hours prior to undergoing surgery
• \> 18 years old that elect to serve as a control group
• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples blood samples

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Azra Bihorac, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 15, 2014
• Study Start: July 1, 2015
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 18, 2025

Record last verified: 2025-06

Locations

US (1)