StrokePhase 2/3NCT02668848
The Fluid Therapy Strategy of the Non-dehydrated Patients With Acute Ischemic Stroke.
A Phase 2/3 study testing water in people with Stroke and Dehydration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Dehydration
- What is being tested?
- water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Feb 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist,
- has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS),
- the time between the onset of neurological symptoms and starting therapy are less than 48 hours,
- admission BUN/Cr<15
Who cannot join
- no informed consent obtained,
- initial NIHSS >15,
- prepared for or received fibrinolytic therapy,
- prepared for or received surgical intervention with 14 days,
- congestive heart failure according to past history or Framingham criteria,
- history of liver cirrhosis or severe liver dysfunction (ALT or AST > x 3 upper normal limit),
Show all 13Show fewer
- admission blood Cr >2 mg/dl,
- initial blood pressure SBP<90 mmHg,
- fever with core temperature >=38°C,
- indication of diuretics for fluid overload,
- any conditions needed more aggressive hydration or blood transfusion,
- cancer under treatment,
- life expectancy or any reasons for follow-up < 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi City, 613
Leng C Lin, MD, +886 05 3621000 ext. 2805, a3456711@ms65.hinet.net
Leng C Lin, MD
About this study
Official title: The Fluid Therapy Strategy of the Patients With Acute Ischemic Stroke and a Bun/Cr Ratio Less Than 15.
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.
Read the 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.
- Conditions
- Stroke, Dehydration
- Being tested
- water
- Keywords
- Stroke, Dehydration, Fluid therapy
- Medical subject headings
- Stroke, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| urine monitoring group | Experimental | 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. Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of post-stroke infection
The post-stroke infection is defined as a core body temperature>38C in any time point.
Measured: the first 7 days after admission
Secondary outcomes (1)
functional outcome
We use modified Rankin scale for neurological evaluation to assess whether USG based hydration therapy results in clinical benefit at three months.
Measured: 3 months after ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leng C Lin, M.D., Principal investigator, Department of Emergency Medicine, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668848
- Sponsor's protocol ID
- CMRPG6e0401
- Status last verified
- Jul 2016
- First submitted
- 27 Jan 2016
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lin LC, Lee JD, Hung YC, Chang CH, Yang JT. Bun/creatinine ratio-based hydration for preventing stroke-in-evolution after acute ischemic stroke. Am J Emerg Med. 2014 Jul;32(7):709-12. doi: 10.1016/j.ajem.2014.03.045. Epub 2014 Apr 4.
PubMed 24768671Lin WC, Shih HM, Lin LC. Preliminary Prospective Study to Assess the Effect of Early Blood Urea Nitrogen/Creatinine Ratio-Based Hydration Therapy on Poststroke Infection Rate and Length of Stay in Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2720-7. doi: 10.1016/j.jstrokecerebrovasdis.2015.08.002. Epub 2015 Aug 31.
PubMed 26338107
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fluid Therapy Strategy of the Patients With Acute Ischemic Stroke and a Bun/Cr Ratio Less Than 15.
- ClinicalTrials.gov ID
- NCT02668848
- Acronym / sponsor ID
- CMRPG6e0401
- Conditions
- Stroke, Dehydration
- Keywords
- Stroke, Dehydration, Fluid therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| urine monitoring group | Experimental | Dietary Supplement: waterPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist,
- has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS),
- the time between the onset of neurological symptoms and starting therapy are less than 48 hours,
- admission BUN/Cr<15
Key exclusion criteria (13 listed)
- no informed consent obtained,
- initial NIHSS >15,
- prepared for or received fibrinolytic therapy,
- prepared for or received surgical intervention with 14 days,
- congestive heart failure according to past history or Framingham criteria,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| waterIf 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. | Dietary supplement | urine monitoring group |
Primary outcome
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.
1 secondary outcome
functional outcome
Time frame: 3 months after ischemic stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Results publication: PubMed 24768671Lin LC, Lee JD, Hung YC, Chang CH, Yang JT. Bun/creatinine ratio-based hydration for preventing stroke-in-evolution after acute ischemic stroke. Am J Emerg Med. 2014 Jul;32(7):709-12. doi: 10.1016/j.ajem.2014.03.045. Epub 2014 Apr 4.
- Results publication: PubMed 26338107Lin WC, Shih HM, Lin LC. Preliminary Prospective Study to Assess the Effect of Early Blood Urea Nitrogen/Creatinine Ratio-Based Hydration Therapy on Poststroke Infection Rate and Length of Stay in Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2720-7. doi: 10.1016/j.jstrokecerebrovasdis.2015.08.002. Epub 2015 Aug 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leng C Lin, M.D. principal investigator
Department of Emergency Medicine, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing water in people with Stroke and Dehydration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leng C Lin, M.D. (+886 53621000 ext. 2805, a3456711@ms65.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of post-stroke infection (time frame: the first 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668848, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.