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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01900275
Enrollment
57
Registered
2013-07-16
Start date
2013-07-31
Completion date
Unknown
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis, Shock, Trauma

Keywords

Sepsis, Trauma, Shock, Acute kidney injury, Heparanase

Brief 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.

Interventions

OTHERUrine collection

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

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injury72 hoursAcute kidney injury will be determined using RIFLE criteria, based upon change in serum creatinine or urine output.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026