StrokePhase 2NCT02143596
Neuroprotective Therapy and Therapeutic Target in Emergency Department
A Phase 2 study testing normal saline in people with Stroke and Dehydration, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Dehydration
- What is being tested?
- normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Dec 2013
- Phase
- Phase 2
- 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 stroke
Who cannot join
- 1.the time between the onset of neurological symptoms and emergency department presentation are more than 12 hours
- 2.required fibrinolytic therapy
- 3.required surgical intervention
- 4.underline disease including congestive heart failure, chronic renal failure ( Cr>2 mg/dl) , liver cirrhosis, chronic obstructive pulmonary disease
- 5. initial systolic blood pressure>200 or diastolic blood pressure > 120 mmHg
- 6.initial systolic blood pressure<100 mmHg
- 7.oxygen saturation less than 92% ( room air )
- 8. require diuretics
Trial locations and contacts
1 site in 1 country.
About this study
The investigators studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio indicates relative dehydration of the patients. An immediate intervention for such patients should be the maintenance of proper hydration.
Read the detailed description
In previous reports, many predictors of early deterioration after ischemic stroke have been proposed and studied, yet the results remain controversial. For example, several studies have been performed to ascertain whether cerebral or systemic causes are the major determinants of stroke deterioration. The findings, however, have been inconsistent. Measures of overall status and stroke severity (low initial Canadian Stroke Severity score, low initial National Institutes of Health Stroke Scale score, early CT findings of stroke severity, and changes in cerebral blood flow affecting the ischemic penumbra as measured by positron emission tomography and single photon emission computed tomography imaging have been shown to predict early deterioration. Laboratory tests for coagulation markers (fibrinogen, D-dimers), inflammatory markers (increased interleukin-6, decreased interleukin-10), serum glucose at admission, hematocrit and physiological parameters, such as blood pressure (both elevated and decreased), and body temperature have been identified as predictors of early deterioration. In addition, patient medical history (diabetes mellitus, atherosclerosis, chronic heart disease) has also been associated with early stroke deterioration. These differing findings may be due to variations in study design, patient populations, selection and exclusion criteria, and the criteria used for defining early deterioration.
A further complication in trying to determine predictors of early deterioration after stroke is that different stroke subtypes may manifest differently in terms of clinical changes before deterioration. In most of the aforementioned studies, no attempt was made to differentiate among stroke subtypes. While others have shown that some proposed markers are statistically significant only for certain stroke subtypes. A predictor of early deterioration that is equally applicable to all stroke subtypes is needed.
The investigators studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio indicates relative dehydration of the patients.
Monitoring of hydration status would also appear to be critical in these patients. Being able to accurately identify patients at risk for early deterioration following stroke will allow for the design of clinical trials of stroke intervention targeting patients with SIE. The investigators need further tests to confirm if the maintenance of proper hydration improve outcome in patients with a Bun/Cr ratio higher than 15.
- Conditions
- Stroke, Dehydration
- Being tested
- normal saline
- Keywords
- stroke, dehydration, prognosis
- Medical subject headings
- Stroke, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
the infusion rate of normal saline is determinated by clinicians according to Bun/Cr ratio followed
| Study group | Role | What they receive |
|---|---|---|
| Bun/Cr based hydration | Active comparator | receive intravenous normal saline infusion and adjust infusion rate by Bun/Cr followed in the first 72 hours Receives: Other: normal saline |
| control | No intervention | receive intravenous normal saline infusion as clinician's adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of stroke in evolution
Measured: 72 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startNov 2010
- Primary completionDec 2013
- Study completionDec 2013
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
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, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143596
- Sponsor's protocol ID
- 100-4630C
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20825831Tei H, Uchiyama S, Ohara K, Kobayashi M, Uchiyama Y, Fukuzawa M. Deteriorating ischemic stroke in 4 clinical categories classified by the Oxfordshire Community Stroke Project. Stroke. 2000 Sep;31(9):2049-54. doi: 10.1161/01.str.31.9.2049.
PubMed 10978028
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Therapy and Therapeutic Target in Emergency Department
- ClinicalTrials.gov ID
- NCT02143596
- Acronym / sponsor ID
- 100-4630C
- Conditions
- Stroke, Dehydration
- Keywords
- stroke, dehydration, prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 May 2014 (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 studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio indicates relative dehydration of the patients. An immediate intervention for such patients should be the maintenance of proper hydration.
Detailed description
In previous reports, many predictors of early deterioration after ischemic stroke have been proposed and studied, yet the results remain controversial. For example, several studies have been performed to ascertain whether cerebral or systemic causes are the major determinants of stroke deterioration. The findings, however, have been inconsistent. Measures of overall status and stroke severity (low initial Canadian Stroke Severity score, low initial National Institutes of Health Stroke Scale score, early CT findings of stroke severity, and changes in cerebral blood flow affecting the ischemic penumbra as measured by positron emission tomography and single photon emission computed tomography imaging have been shown to predict early deterioration. Laboratory tests for coagulation markers (fibrinogen, D-dimers), inflammatory markers (increased interleukin-6, decreased interleukin-10), serum glucose at admission, hematocrit and physiological parameters, such as blood pressure (both elevated and decreased), and body temperature have been identified as predictors of early deterioration. In addition, patient medical history (diabetes mellitus, atherosclerosis, chronic heart disease) has also been associated with early stroke deterioration. These differing findings may be due to variations in study design, patient populations, selection and exclusion criteria, and the criteria used for defining early deterioration.
A further complication in trying to determine predictors of early deterioration after stroke is that different stroke subtypes may manifest differently in terms of clinical changes before deterioration. In most of the aforementioned studies, no attempt was made to differentiate among stroke subtypes. While others have shown that some proposed markers are statistically significant only for certain stroke subtypes. A predictor of early deterioration that is equally applicable to all stroke subtypes is needed.
The investigators studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Following multivariate analysis, only a Bun/Cr >15 was independent predictor of SIE. These patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio indicates relative dehydration of the patients.
Monitoring of hydration status would also appear to be critical in these patients. Being able to accurately identify patients at risk for early deterioration following stroke will allow for the design of clinical trials of stroke intervention targeting patients with SIE. The investigators need further tests to confirm if the maintenance of proper hydration improve outcome in patients with a Bun/Cr ratio higher than 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bun/Cr based hydration | Active comparator | Other: normal salinereceive intravenous normal saline infusion and adjust infusion rate by Bun/Cr followed in the first 72 hours |
| control | No intervention | –receive intravenous normal saline infusion as clinician's adjustment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- acute stroke
Key exclusion criteria (8 listed)
- 1.the time between the onset of neurological symptoms and emergency department presentation are more than 12 hours
- 2.required fibrinolytic therapy
- 3.required surgical intervention
- 4.underline disease including congestive heart failure, chronic renal failure ( Cr>2 mg/dl) , liver cirrhosis, chronic obstructive pulmonary disease
- 5. initial systolic blood pressure>200 or diastolic blood pressure > 120 mmHg
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 |
|---|---|---|
| normal salinethe infusion rate of normal saline is determinated by clinicians according to Bun/Cr ratio followed | Other | Bun/Cr based hydration |
Primary outcome
rate of stroke in evolution
Time frame: 72 hours after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Background: PubMed 20825831Lin 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.
- Background: PubMed 10978028Tei H, Uchiyama S, Ohara K, Kobayashi M, Uchiyama Y, Fukuzawa M. Deteriorating ischemic stroke in 4 clinical categories classified by the Oxfordshire Community Stroke Project. Stroke. 2000 Sep;31(9):2049-54. doi: 10.1161/01.str.31.9.2049.
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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
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 study testing normal saline 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 26 May 2014. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of stroke in evolution (time frame: 72 hours 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 NCT02143596, 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 26 May 2014.