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BUN/Cr-based Hydration Therapy to Improve Outcomes for Dehydrated Patients With Acute Ischemic Stroke. (HYDO)

This study is currently recruiting participants.
Verified July 2016 by Chang Gung Memorial Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02099383
First Posted: March 28, 2014
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
  Purpose

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.


Condition Intervention Phase
Stroke Dehydration Other: normal saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Trial of BUN/Cr-based Hydration Therapy to Reduce Stroke-in-evolution and Improve Short-term Functional Outcomes for Dehydrated Patients With Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • rate of stroke-in-evolution [ Time Frame: 72 hours ]
    Stroke-in-evolution is defined as a deterioration from base line in the score on the NIHSS by 4 or more points.


Secondary Outcome Measures:
  • rate of favorable outcome [ Time Frame: three months ]
    Scores of >=60 on the Barthel index, <=2 on the modified Rankin scale are considered to indicate a favorable outcome.


Estimated Enrollment: 244
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: normal saline, bolus
Patients 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.
Other: normal saline
intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours
No Intervention: normal saline, control
Patients of control group will receive intravenous normal saline 60 cc per hour.

Detailed Description:

The investigators have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of SIE among patients who had suffered acute ischemic stroke. The investigators found that patients who had a BUN/Cr ratio ≥ 15 were 3.4-fold more likely to experience SIE than patients who had a BUN/Cr ratio < 15. The ratio of SIE was 13.9% in all patients, with 20% in patients who had a BUN/Cr ratio ≥ 15 and 8.3% in patients who had a BUN/Cr ratio < 15. Among the patients presenting with acute ischemic stroke, 37% of them had a BUN/Cr ratio ≥ 15.

The investigators' recent pilot study was designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 reduces the occurrence of SIE after acute ischemic stroke. Patients in the hydration group received a significantly larger (all P < 0.001) median volume of infused saline than patients in the control group. And this allowed 82% of the patients to maintain their BUN/Cr ratio <15 in first 8 hours. The proportion of patients who experienced SIE was significantly lower in the hydration group compared with the control group.

Dehydration, as indicated by an increased BUN/Cr ratio, is known to be relatively common among patients who have experienced stroke. According to the result of our pilot study, a hydration strategy with intravenous 20 cc per kilogram of body weight normal saline in first 8 hours was safe and effective to prevent dehydration related early neurological deterioration.

In this study, the investigators conduct a randomized double-blind control trial to test the hypothesis that whether BUN/Cr ratio based hydration therapy has clinical activity.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099383


Contacts
Contact: Leng C Lin, MD +886 05 3621000 ext 2805 a3456711@ms65.hinet.net

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Chiayi, Taiwan, 613
Contact: Leng C Lin, MD    +886 05 3621000 ext 2805    a3456711@ms65.hinet.net   
Principal Investigator: Leng C Lin, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Leng C Lin, MD Department of Emergency Medicine, Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02099383     History of Changes
Other Study ID Numbers: CPRPG6D0011
First Submitted: March 26, 2014
First Posted: March 28, 2014
Last Update Posted: June 23, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chang Gung Memorial Hospital:
Stroke
Dehydration
Fluid Therapy

Additional relevant MeSH terms:
Stroke
Dehydration
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes