Acute Kidney InjuryNavigateAKINCT02114138
Network Analysis of Urinary Molecular Signature Complements Clinical Data to Predict Postoperative Acute Kidney Injury
An observational study of Acute Kidney Injury, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- pathogenesis of perioperative acute kidney injury and urine collection
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Radiation Therapy
- Chemo Therapy
- Immunosuppressive Therapy
- IV contrast within the past 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- pathogenesis of perioperative acute kidney injury, urine collection
- Keywords
- postoperative acute kidney injury, pAKI, stress injury on the kidney, chronic kidney disease, CKD
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathogenesis of perioperative acute kidney injuryProcedure or surgery
understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery
urine collectionDiagnostic test
urine collection will be performed on both the control group and hospitalized participants
| Study group | Role | What they receive |
|---|---|---|
| Surgical Group | Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection Receives: 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. Receives: Diagnostic Test: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days after surgery.
Secondary outcomes (2)
Change from baseline in urine protein biomarkers at 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.
Measured: Baseline, 4 hours after surgery
Change from baseline in urine protein biomarkers at postoperative day 1
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
Measured: Baseline, day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJul 2015
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azra Bihorac, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114138
- Sponsor's protocol ID
- IRB201400127
- Acronym
- NavigateAKI
- Status last verified
- Jun 2025
- First submitted
- 24 Mar 2014
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02114138
- Acronym / sponsor ID
- NavigateAKI / IRB201400127
- Conditions
- Acute Kidney Injury
- Keywords
- postoperative acute kidney injury, pAKI, stress injury on the kidney, chronic kidney disease, CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Group | – | Procedure: pathogenesis of perioperative acute kidney injury, Diagnostic Test: urine collectionAdults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection |
| Healthy Control | – | Diagnostic Test: urine collectionHealthy Adult volunteers who are willing to provide a 200 ml urine sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Patients not recruited 4 hours prior to undergoing surgery
- Renal Replacement Therapy AKI/CKD Nephrectomy Organ transplant
- Stroke/Transient Ischemic Attack
- Heart Attack
- Major Thoracic, abdominal, or Vascular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pathogenesis of perioperative acute kidney injuryunderstand pathogenesis of perioperative acute kidney injury in elective and emergent surgery | Procedure or surgery | Surgical Group |
| urine collectionurine collection will be performed on both the control group and hospitalized participants | Diagnostic test | Healthy Control, Surgical Group |
Primary outcome
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.
2 secondary outcomes
Change from baseline in urine protein biomarkers at 4 hours after surgery
Time frame: Baseline, 4 hours after surgery
Change from baseline in urine protein biomarkers at postoperative day 1
Time frame: Baseline, day 1 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Bihorac, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postoperative acute kidney injury (pAKI) (time frame: up to 7 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.