Stroke | BUN/Cr-based Hydration Therapy to Improve Outcomes for Dehydrated Patients With Acute Ischemic Stroke.
Stroke research study
What is the primary objective of this study?
The investigators' preliminary findings suggest that providing patients with acute ischemic stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the occurrence of stroke-in-evolution(SIE) and therefore improve prognosis. The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution 72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based hydration therapy. Part 2, The investigators use two outcome measures, including Barthel index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio based hydration therapy results in sustained clinical benefit at three months.
Who is eligible to participate?
Inclusion Criteria: 1. Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist. 2. has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS) 3. the time between the onset of neurological symptoms and starting therapy are less than 12 hours 4. admission BUN/Cr≧15 Exclusion Criteria: 1. no informed consent obtained 2. initial NIHSS >15 3. prepared for or received fibrinolytic therapy 4. prepared for or received surgical intervention with 14 days 5. congestive heart failure according to past history or Framingham criteria 6. history of liver cirrhosis or severe liver dysfunction (alanine aminotransferase or aspartate aminotransferase > x 3 upper normal limit) 7. admission blood Cr >2 mg/dl 8. initial systolic blood pressure <90 mmHg 9. fever with core temperature >=38°C 10. indication of diuretics for fluid overload 11. any conditions needed more aggressive hydration or blood transfusion 12. cancer under treatment 13. life expectancy or any reasons for follow-up < 3 months
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:normal salineintravenous normal saline 20cc per kilogram of body weight over a period of 8 hours
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
normal saline, bolusPatients of study group will receive intravenous normal saline 20cc per kilogram of body weight, one third of which will be given as a bolus followed by delivery of the remaining two third as a constant infusion over a period of 8 hours.
normal saline, controlPatients of control group will receive intravenous normal saline 60 cc per hour.
Start Date: April 2014
Completed Date: April 2018
Phase: Phase 3
Primary Outcome: rate of stroke-in-evolution
Secondary Outcome: rate of favorable outcome
Study sponsors, principal investigator, and references
Principal Investigator: Leng C Lin, MD
Lead Sponsor: Chang Gung Memorial Hospital
Lin LC, Yang JT, Weng HH, Hsiao CT, Lai SL, Fann WC. Predictors of early clinical deterioration after acute ischemic stroke. Am J Emerg Med. 2011 Jul;29(6):577-81. doi: 10.1016/j.ajem.2009.12.019. Epub 2010 Apr 2.