ARC in Hemorrhagic Stroke | NCT02386202

Studies
ARC in Hemorrhagic Stroke

NCT02386202

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Hemorrhagic Stroke
Augmented Renal Clearance

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Mar 5, 2015

First Submission Date that Met QC Criteria

Mar 10, 2015

First Posted Date

Mar 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with hemorrhagic stroke		All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No interventions	Patients with hemorrhagic stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Over neurosciences intensive care unit stay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

30 patients with hemorrhagic stroke admitted to the University of North Carolina Neurosciences Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathryn A Morbitzer, PharmD	UNC Eshelman School of Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina Hospitals		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D000083302	Hemorrhagic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided