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

NCT01900275 | Completed

• 2 other identifiers: COMIRB 13-0425UL1TR000154
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Trauma; Shock; Acute Kidney Injury

Keywords

Sepsis; Trauma; Shock; Acute kidney injury; Heparanase

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

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

  72 hours

Study Arms (1)

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

Interventions

Urine collection OTHER

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

Septic shock or major trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 26926297 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine will be collected, centrifuged, and frozen

MeSH Terms

Conditions

Sepsis; Wounds and Injuries; Shock; Acute Kidney Injury

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Eric P Schmidt, MD

  Denver Health Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 16, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

US (1)