Acute Kidney Injury in Critically Ill Patients

Acute Renal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765464
• Other study ID #: 5160026
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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