StrokePhase 3HYDONCT02099383
BUN/Cr-based Hydration Therapy to Improve Outcomes for Dehydrated Patients With Acute Ischemic Stroke.
A Phase 3 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' 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. 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
- 244 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Jul 2020
- Phase
- Phase 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 12 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 (alanine aminotransferase or aspartate aminotransferase > x 3 upper normal limit)
Show all 13Show fewer
- admission blood Cr >2 mg/dl
- initial systolic blood pressure <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.
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Dehydration
- Being tested
- normal saline
- 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.
normal salineOther
intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours
| Study group | Role | What they receive |
|---|---|---|
| normal saline, bolus | Active comparator | 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. Receives: Other: normal saline |
| normal saline, control | No intervention | Patients of control group will receive intravenous normal saline 60 cc per hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of stroke-in-evolution
Stroke-in-evolution is defined as a deterioration from base line in the score on the NIHSS by 4 or more points.
Measured: 72 hours
Secondary outcomes (1)
rate of favorable outcome
Scores of >=60 on the Barthel index, <=2 on the modified Rankin scale are considered to indicate a favorable outcome.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2020
- Study completionJul 2020
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leng C Lin, MD, Principal investigator, Department of Emergency Medicine, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099383
- Sponsor's protocol ID
- CPRPG6D0011
- Acronym
- HYDO
- Status last verified
- Nov 2018
- First submitted
- 26 Mar 2014
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 20825831Lin LC, Lee TH, Huang YC, Tsai YH, Yang JT, Yang LY, Pan YB, Lee M, Chen KF, Hung YC, Cheng HH, Lee IN, Lee MH, Chiu T, Chang YJ, Goh ZNL, Seak CJ. Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial. Int J Stroke. 2024 Oct;19(9):1010-1019. doi: 10.1177/17474930241259940. Epub 2024 Jul 31.
PubMed 38785314
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02099383
- Acronym / sponsor ID
- HYDO / CPRPG6D0011
- Conditions
- Stroke, Dehydration
- Keywords
- Stroke, Dehydration, Fluid Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 28 Mar 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' 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline, bolus | Active comparator | Other: normal salinePatients 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. |
| normal saline, control | No intervention | –Patients of control group will receive intravenous normal saline 60 cc per hour. |
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 12 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 |
|---|---|---|
| normal salineintravenous normal saline 20cc per kilogram of body weight over a period of 8 hours | Other | normal saline, bolus |
Primary outcome
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.
1 secondary outcome
rate of favorable outcome
Time frame: three months
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 8 Sep 2021.
- 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.
- Derived from this study: PubMed 38785314Lin LC, Lee TH, Huang YC, Tsai YH, Yang JT, Yang LY, Pan YB, Lee M, Chen KF, Hung YC, Cheng HH, Lee IN, Lee MH, Chiu T, Chang YJ, Goh ZNL, Seak CJ. Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial. Int J Stroke. 2024 Oct;19(9):1010-1019. doi: 10.1177/17474930241259940. Epub 2024 Jul 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, MD 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 3 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 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: finished, as of the sponsor's last update on 8 Sep 2021. 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 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?
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). 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 NCT02099383, 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 8 Sep 2021.