Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital, Hospital, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | July 2013 |
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.
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.
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.
We found this trial at
1
site
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
Click here to add this to my saved trials
