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

Sponsor

Denver Health and Hospital Authority (Other)

Overall Status

Completed

CT.gov ID

NCT01900275

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Trauma Shock Acute Kidney Injury	Other: Urine collection

Study Design

Study Type:

Observational

Actual Enrollment :

57 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Septic shock or major trauma Patients admitted within 24 hours to ICU for septic shock or major trauma (ISS > 15). Septic shock is defined by sepsis with hypotension requiring >4 hours of vasopressor support over previous 24 hours.	Other: Urine collection Collection of 5 ml urine from urinary collection device (e.g. foley catheter).

Arm

Intervention/Treatment

Septic shock or major trauma

Patients admitted within 24 hours to ICU for septic shock or major trauma (ISS > 15). Septic shock is defined by sepsis with hypotension requiring >4 hours of vasopressor support over previous 24 hours.

Other: Urine collection

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

Outcome Measures

Primary Outcome Measures

Acute kidney injury [72 hours]
Acute kidney injury will be determined using RIFLE criteria, based upon change in serum creatinine or urine output.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.