SepsisNCT01900275
Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults
An observational study of Sepsis and Trauma, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Urine collection
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adults admitted to the Denver Health MICU or SICU for either (a) septic shock or (b) major trauma.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
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
- Being tested
- Urine collection
- Keywords
- Sepsis, Trauma, Shock, Acute kidney injury, Heparanase
- Medical subject headings
- Sepsis, Wounds and Injuries, Shock, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collectionOther
Collection of 5 ml urine from urinary collection device (e.g. foley catheter).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Acute kidney injury will be determined using RIFLE criteria, based upon change in serum creatinine or urine output.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Schmidt, Denver Health and Hospital Authority
- Investigators
- Eric P Schmidt, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900275
- Sponsor's protocol ID
- COMIRB 13-0425
- Other IDs
- UL1TR000154
- Status last verified
- Nov 2014
- First submitted
- 12 Jul 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26926297
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Heparanase Activity as a Predictor of Acute Kidney Injury in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT01900275
- Acronym / sponsor ID
- COMIRB 13-0425
- Conditions
- Sepsis, Trauma, Shock, Acute Kidney Injury
- Keywords
- Sepsis, Trauma, Shock, Acute kidney injury, Heparanase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock or major trauma | – | Other: Urine collectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adults admitted to the Denver Health MICU or SICU for either (a) septic shock or (b) major trauma.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collectionCollection of 5 ml urine from urinary collection device (e.g. foley catheter). | Other | Septic shock or major trauma |
Primary outcome
Acute kidney injury
Time frame: 72 hours
Acute kidney injury will be determined using RIFLE criteria, based upon change in serum creatinine or urine output.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 26926297Schmidt 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
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Streptococcus Agalactiae Infection, Neonatal Sepsis
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Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric P Schmidt, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Trauma, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.