NCT02386202

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

March 5, 2015

Last Update Submit

December 1, 2015

Conditions

Hemorrhagic StrokeAugmented Renal Clearance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with hemorrhagic stroke

All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment.

Other: No intervention

Interventions

No interventionOTHER

No interventions

Patients with hemorrhagic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kathryn A Morbitzer, PharmD

    UNC Eshelman School of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

US(1)