ARC in Hemorrhagic Stroke

Hemorrhagic Stroke Clinical Trial

Official title:

Augmented Renal Clearance in Hemorrhagic Stroke Patients Admitted to the Neurosciences Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386202
• Other study ID #: 14-1491
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: December 1, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Augmented Renal Clearance
• Hemorrhagic Stroke
• Intracranial Hemorrhages
• Stroke

Intervention

Other:
• No intervention
No interventions

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No