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NCT Number: NCT02114138

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pathogenesis of perioperative acute kidney injury

Procedure

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

Urine collection

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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)

Acronym: NavigateAKI

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Apr 15, 2014
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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