Clinical trial NCT01900275: Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults
Official title: Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Trauma
Shock
Acute Kidney Injury
Keywords: Sepsis
Trauma
Shock
Acute kidney injury
Heparanase
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill adults admitted to the Denver Health MICU or SICU for either (a) septic shock or (b) major trauma.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute kidney injury
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Eric P Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt EP, Overdier KH, Sun X, Lin L, Liu X, Yang Y, Ammons LA, Hiller TD, Suflita MA, Yu Y, Chen Y, Zhang F, Cothren Burlew C, Edelstein CL, Douglas IS, Linhardt RJ. Urinary Glycosaminoglycans Predict Outcomes in Septic Shock and Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2016 Aug 15;194(4):439-49. doi: 10.1164/rccm.201511-2281OC.