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

Active, not recruiting

• Conditions: Acute Kidney Injury
• Interventions: Procedure: pathogenesis of perioperative acute kidney injury; Diagnostic Test: urine collection

• Registration Number: NCT02114138
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-15
• Study Start: 2015-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical Group	pathogenesis of perioperative acute kidney injury	Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection
Surgical Group	urine collection	Adults undergoing major in hospital surgery; pathogenesis of perioperative acute kidney injury; urine collection
Healthy Control	urine collection	Healthy Adult volunteers who are willing to provide a 200 ml urine sample.

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative acute kidney injury (pAKI)	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 Outcome Measures

Name	Time	Method
Change from baseline in urine protein biomarkers at 4 hours after surgery	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.
Change from baseline in urine protein biomarkers at postoperative day 1	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

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States