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

Acute Kidney Injury Clinical Trial

— NavigateAKI  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02114138
• Other study ID #: IRB201400127
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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

Diagnostic Test:
• urine collection
urine collection will be performed on both the control group and hospitalized participants

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All cause mortality	Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 12 months post-discharge from the hospital.	12 months post-discharge from the hospital.
Other	Prolonged mechanical ventilation	Time-to-Event Outcome Measure taken when mechanical ventilation is greater than 48 hours during hospitalization.	Up to 6 months
Other	chronic kidney disease (CKD)	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.	12 months post-discharge from the hospital.
Other	all cause mortality	Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at hospital discharge.	up to 6 months
Other	all cause mortality	Time-to-Event Outcome Measure followed for the duration of study enrollment and specifically measured at 6 months post-discharge from the hospital.	6 months post-discharge from the hospital.
Other	chronic kidney disease (CKD)	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.	6 months post-discharge from the hospital.
Primary	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	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.	Baseline, 4 hours after surgery
Secondary	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	Baseline, day 1 after surgery