The Fluid Therapy Strategy of the Non-dehydrated Patients With Acute Ischemic Stroke.
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|ClinicalTrials.gov Identifier: NCT02668848|
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke Dehydration||Dietary Supplement: water||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Fluid Therapy Strategy of the Patients With Acute Ischemic Stroke and a Bun/Cr Ratio Less Than 15.|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||February 2018|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668848
|Contact: Leng C Lin, M.D.||+886 53621000 ext firstname.lastname@example.org|
|Contact: Jen T Yang, PHD||+886 email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Chiayi, Taiwan, 613|
|Contact: Leng C Lin, MD +886 05 3621000 ext 2805 firstname.lastname@example.org|
|Principal Investigator: Leng C Lin, MD|
|Principal Investigator:||Leng C Lin, M.D.||Department of Emergency Medicine, Chang Gung Memorial Hospital|