Hemorrhagic StrokeNCT02386202
ARC in Hemorrhagic Stroke
An observational study of Hemorrhagic Stroke and Augmented Renal Clearance, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Stroke, Augmented Renal Clearance
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2015
- 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: 30 patients with hemorrhagic stroke admitted to the University of North Carolina Neurosciences Intensive Care Unit
Who may be able to join
- Adults ≥ 18 years
- Patients with hemorrhagic stroke
- Anticipated length of stay in the neuroscience intensive care unit > 48 hours
- Informed consent provided by the patient or by the patient's designated medical proxy
Who cannot join
- Pregnancy
- Patients with pre-existing renal dysfunction (chronic kidney disease stages 3 - 5)
- Patients receiving renal replacement therapy
- Patients with an admission serum creatinine > 1.4 mg/dL
- Patients with non-aneurysmal subarachnoid hemorrhage
- Patients with history of nephrectomy or body mass index < 18 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: Augmented Renal Clearance in Hemorrhagic Stroke Patients Admitted to the Neurosciences Intensive Care Unit
To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.
- Conditions
- Hemorrhagic Stroke, Augmented Renal Clearance
- Being tested
- No intervention
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Patients with hemorrhagic stroke | All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the onset, magnitude, and change over time of ARC in patients with hemorrhagic stroke
Daily 8-hour urine collections will be performed to directly measure creatinine clearance up to ICU discharge
Measured: Over neurosciences intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokeStudies 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
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn A Morbitzer, PharmD, Principal investigator, UNC Eshelman School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386202
- Sponsor's protocol ID
- 14-1491
- Status last verified
- Dec 2015
- First submitted
- 5 Mar 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Renal Clearance in Hemorrhagic Stroke Patients Admitted to the Neurosciences Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02386202
- Acronym / sponsor ID
- 14-1491
- Conditions
- Hemorrhagic Stroke, Augmented Renal Clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Mar 2015 (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.
To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hemorrhagic stroke | – | Other: No interventionAll patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with hemorrhagic stroke admitted to the University of North Carolina Neurosciences Intensive Care Unit
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Patients with hemorrhagic stroke
- Anticipated length of stay in the neuroscience intensive care unit > 48 hours
- Informed consent provided by the patient or by the patient's designated medical proxy
Key exclusion criteria (6 listed)
- Pregnancy
- Patients with pre-existing renal dysfunction (chronic kidney disease stages 3 - 5)
- Patients receiving renal replacement therapy
- Patients with an admission serum creatinine > 1.4 mg/dL
- Patients with non-aneurysmal subarachnoid hemorrhage
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 |
|---|---|---|
| No interventionNo interventions | Other | Patients with hemorrhagic stroke |
Primary outcome
To describe the onset, magnitude, and change over time of ARC in patients with hemorrhagic stroke
Time frame: Over neurosciences intensive care unit stay
Daily 8-hour urine collections will be performed to directly measure creatinine clearance up to ICU discharge
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 2 Dec 2015.
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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.
Kathryn A Morbitzer, PharmD principal investigator
UNC Eshelman School of Pharmacy
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 Hemorrhagic Stroke and Augmented Renal Clearance, run by University of North Carolina, Chapel Hill 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 4 inclusion and 6 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 2 Dec 2015. 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?
To describe the onset, magnitude, and change over time of ARC in patients with hemorrhagic stroke (time frame: Over neurosciences intensive care unit stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.