Acute Kidney Injury in Critically Ill Patients

NCT02765464 | Completed

• 1 other identifier: 5160026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Renal Injury

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects must be trauma patients with multiple injuries.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ronak Raval, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 6, 2016
• Study Start: October 1, 2016
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)