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

NCT ID: NCT01900275

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Trauma Shock Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Urine collection

Intervention Type OTHER

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

Interventions

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Urine collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Eric Schmidt

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric P Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health Medical Center

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26926297 (View on PubMed)

Other Identifiers

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UL1TR000154

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COMIRB 13-0425

Identifier Type: -

Identifier Source: org_study_id