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The Fluid Therapy Strategy of the Non-dehydrated Patients With Acute Ischemic Stroke.

This study is currently recruiting participants.
Verified July 2016 by Chang Gung Memorial Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02668848
First Posted: January 29, 2016
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 previously found that a blood urea nitrogen/creatinine (BUN/Cr) ratio >15 is an independent predictor of early deterioration after acute ischemic stroke. Another study was conducted to determine whether urine specific gravity, another indicator of hydration status and one more easily obtained, is also an independent predictor of early deterioration or stroke-in-evolution (SIE) in such patients. The investigators also conducted a preliminary study, enrolling ischemic stroke patients with a BUN/Cr ratio >15 and find daily Bun/Cr based hydration help to decrease post stroke infection rate and improve 3 months functional outcome. In this study, daily urine specific gravity will be used to adjust hydration therapy in ischemic stroke patients with initial Bun/Cr ratio <15. The primary outcome is the post stroke infection rate in the first 7 days after admission, and secondary outcome is 3 months functional outcome using mRS.

Condition Intervention Phase
Stroke Dehydration Dietary Supplement: water Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Fluid Therapy Strategy of the Patients With Acute Ischemic Stroke and a Bun/Cr Ratio Less Than 15.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • the rate of post-stroke infection [ Time Frame: the first 7 days after admission ]
    The post-stroke infection is defined as a core body temperature>38C in any time point.


Secondary Outcome Measures:
  • functional outcome [ Time Frame: 3 months after ischemic stroke ]
    We use modified Rankin scale for neurological evaluation to assess whether USG based hydration therapy results in clinical benefit at three months.


Estimated Enrollment: 250
Study Start Date: January 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: urine monitoring group
Patients of urine monitoring group will be checked for urine specific gravity (USG) once between 6a.m. to 12 m.d. in the first 5 days after admission. Patients will be advised to have water according to the level of USG.
Dietary Supplement: water
If USG>1.02, patients will be advised to drink water via oral or tubal feeding with a dose of 5cc/kg body weight , maximum 300cc, and repeat the same amount of water after dinner in the same day.

Detailed Description:

Stroke remains a major medical issue. According to the American Heart Association (AHA) report in 2012, a new or recurrent stroke occurs in around 795,000 people each year, and 1 out of every 18 deaths in the United States is due to stroke. The incidence of stroke may be even higher in the Chinese population than in the US population. In Taiwan, the average annual incidence rate of first-ever stroke for people above 36 years is 330 per 100,000. The associated disease burden of stroke is increasing annually and remains a significant health concern. Common medical complications of stroke include infections, falls, pressure sores, and depression. A systematic review showed that 30% of patients develop post-stroke infection. Though rates of pneumonia and urinary tract infection after stroke are both 10%, pneumonia is associated with higher mortality. If stroke patients become infected during admission, they may experience neurologic deterioration, poor functional outcome, and increased length of stay (LOS).

Adequate hydration is necessary for maintenance of physiologic homeostasis. Dehydration is a frequent cause of mortality in elderly patients. Dehydration is a common and early feature of acute ischemic stroke and may be a contributor to poor outcomes. In the absence of known biological markers of dehydration, biochemical data were analyzed to identify such markers. These studies showed that the blood urea nitrogen (BUN)/creatinine (Cr) ratio ≥ 15 can be used as a marker of dehydration. Our previous study also revealed that BUN/Cr ratio ≥ 15 is an independent predictor of stroke-in-evolution (SIE). These studies suggest that BUN/Cr ratio may used to identify those patients with acute ischemic stroke who are dehydrated and will benefit from hydration therapy.

The investigators then conducted a phase II single arm control trial of patients with acute ischemic stroke and BUN/Cr ratio ≥15 conducted from January 2011 to December 2013. The results demonstrated blood urea nitrogen/creatinine (BUN/Cr)-based hydration therapy decreases the length of stay (LOS) and rate of post-stroke infection.

Since the BUN/Cr ratio is an indicator of hydration status, and urine specific gravity is also an indicator of hydration status, the investigators hypothesized that urine specific gravity would also be an independent predictor of early deterioration. A urine specific gravity >1.010 indicates that urine is concentrating in the kidneys which means that the body might be relatively dehydrated. Because such an increase in urine specific gravity occurs earlier than an increase in the BUN/Cr ratio, the investigators thought that an increase in urine specific gravity might be an earlier predictor of early deterioration in ischemic stroke than the BUN/Cr ratio.

In this study, daily urine specific gravity will be used to adjust hydration therapy in ischemic stroke patients with initial Bun/Cr ratio <15. The primary outcome is the post stroke infection rate in the first 7 days after admission, and secondary outcome is 3 months functional outcome using mRS.

  Eligibility

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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 48 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 (ALT or AST > x 3 upper normal limit),
  7. admission blood Cr >2 mg/dl,
  8. initial blood pressure SBP<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): NCT02668848


Contacts
Contact: Leng C Lin, M.D. +886 53621000 ext 2805 a3456711@ms65.hinet.net
Contact: Jen T Yang, PHD +886 975353203 jents716@ms32.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, M.D. Department of Emergency Medicine, Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02668848     History of Changes
Other Study ID Numbers: CMRPG6e0401
First Submitted: January 27, 2016
First Posted: January 29, 2016
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