Acute Kidney Injury in Critically Ill Patients

Predicting Acute Kidney Injury in Critically Ill Trauma Patients Using Metalloproteinase 2 (TIMP2) and Insulin-like Growth Factor Binding Protein7 (IGFBP 7)

Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly increase mortality, length of stay, and costs, however detection has proven difficult as markers like elevated creatinine and decreased urine output may take days to manifest and are late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has been shown to increase within 12 hours following renal insult, allowing assessment of risk for developing acute kidney injury. Therefore, the investigators plan to assess if acute kidney injury in critically ill trauma patients can be determined earlier using urinary TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been specifically evaluated in trauma patients at risk of AKI.

Study Overview

• Status: Completed
• Conditions: Acute Renal Injury

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects must be trauma patients with multiple injuries.

Description

Inclusion Criteria:

• trauma patients with multiple injuries;
• abdominal injuries;
• crush injuries;
• those who present in shock (systolic blood pressure <90 or mean arterial pressure <65);
• require blood transfusions, vasopressors or mechanical ventilation

Exclusion Criteria:

• known pregnancy;
• patients under 21 years of age;
• known moderate to severe AKI prior to enrollment and end stage renal disease. known moderate to severe AKI prior to enrollment and end stage renal disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of u rinary metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP-7) biomarker elevation that corresponds to acute kidney injury by creatinine and urine output	one year

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Ronak Raval, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 5160026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO