Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults

Sepsis Clinical Trial

Official title:

Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900275
• Other study ID #: COMIRB 13-0425
• Secondary ID: UL1TR000154
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: November 21, 2014
• Start date: July 2013

Study information

• Verified date: November 2014
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Across the world, the most common cause of dying in the ICU is a disease called "sepsis". Sepsis is a disease in which the body's protective response to infection becomes too intense, unnecessarily damaging important organs in the body. Kidney damage during sepsis is particularly bad, as a person's chance of survival drops significantly when he or she develops kidney failure. This study plans to learn more about how to detect (and thus prevent) kidney failure early in sepsis. The current tests doctors use only detect kidney failure once it's already happened. We must therefore find better ways of detecting kidney failure earlier, when there is still a chance to protect the kidneys.

In this study, patients will provide a one-time sample of urine. We will check this urine for signs of a protein called "heparanase", which we believe is important in early kidney failure. We will then see if high heparanase activity in urine predicts the risk of developing kidney failure. We will compare results from patients with sepsis with results from patients with trauma, allowing us to determine if heparanase is only important in sepsis kidney failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Septic shock or major trauma. Septic shock will be defined by standard criteria including (a) the presence of the systemic inflammatory response syndrome (SIRS), (b) evidence of infection, and (c) treatment with vasopressor medications for > 4 hours despite > 30 ml/kg intravenous crystalloid resuscitation. As a critically-ill comparator group, we will also enroll adult patients admitted (within 24 hours prior to screening) to the Denver Health Surgical ICU with major trauma, as defined by an Injury Severity Score of > 15.

Exclusion Criteria:

Exclusion criteria include anuria, prisoners, absence of a routinely-inserted urine collection device, or gross hematuria. Additionally, patients with known genitourinary malignancy will be excluded, given that cancers are known to overexpress heparanase. Additional exclusion criteria include age < 18 years, and pregnant women.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Sepsis
• Shock
• Trauma

Intervention

Other:
• Urine collection
Collection of 5 ml urine from urinary collection device (e.g. foley catheter).

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury	Acute kidney injury will be determined using RIFLE criteria, based upon change in serum creatinine or urine output.	72 hours	No