ARC in Hemorrhagic Stroke

December 1, 2015 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with hemorrhagic stroke
All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment.
Other: No intervention
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Over neurosciences intensive care unit stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Kathryn A Morbitzer, PharmD, UNC Eshelman School of Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1491

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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