Ischemic StrokePhase 3IVISNCT02003794
Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
A Phase 3 study testing 0.9% NaCl solution in people with Ischemic Stroke, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- 0.9% NaCl solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to Jan 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18-80 years
- NIHSS ≥ 1
- Diagnosis of acute ischemic stroke within 72 hours from stroke onset
- Enrollment into the study within 24 hours after hospital arrival
- Urine specific gravity level < 1.030
- Patient consent
Who cannot join
- Patients receiving > 40 ml/hr IV fluid infusion over 3 hours
- Acute ischemic stroke caused cardiogenic embolism
- Urine specific gravity ≥ 1.030
- Large cerebral infarction area
- Infarction > 1/3 of middle cerebral artery area
- Infarction > 1/2 of cerebellar hemisphere
Show all 18Show fewer
- NHISS ≥ 18
- Previous or current episode of atrial fibrillation
- Previous or current episode congestive heart failure
- Previous echocardiogram with ejection fraction < 40%
- Previous or current episode of dilated cardiomyopathy
- Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2
- Modified Rankin scale before acute ischemic stroke ≥ 2
- Patients receiving intravenous thrombolysis
- NPO with need for IV fluid
- IV fluid infusion needed from any other causes
- Patients with poor prognosis with life expectancy < 90 days
- Patients involved in other ongoing clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.
Read the detailed description
This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- 0.9% NaCl solution
- Keywords
- acute ischemic stroke, intravenous fluid, ้hydration
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% NaCl solutionDrug
Also called Normal saline
0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
| Study group | Role | What they receive |
|---|---|---|
| IV Fluid | Experimental | 0.9% NaCl solution infusion: 100 ml/hr for three days. Receives: Drug: 0.9% NaCl solution |
| No IV Fluid | No intervention | Not receive any intravenous fluid but can consume oral fluid normally for three days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS ≤ 4
Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.
Measured: day 7 after treatment or on the day of discharge
Secondary outcomes (4)
mRS ≤ 1
Patients with mRS ≤ 1 at day 7 after treatment or on the day of discharge, which ever comes first.
Measured: day 7 after treatment or on the day of discharge
mRS ≤ 4
Patients with mRS ≤ 4 at day 90
Measured: at day 90
mRS ≤ 1
Patients with mRS ≤ 1 at day 90
Measured: at day 90
change of serum osmolarity
Percentage of change of serum osmolarity at day 3 after treatment
Measured: at day 3 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: More progressive stroke in one arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Nijasri C Suwanwela, Chulalongkorn University
- Investigators
- Nijasri C Suwanwela, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003794
- Sponsor's protocol ID
- IVIS 001
- Acronym
- IVIS
- Status last verified
- Aug 2015
- First submitted
- 3 Dec 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
- ClinicalTrials.gov ID
- NCT02003794
- Acronym / sponsor ID
- IVIS / IVIS 001
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, intravenous fluid, ้hydration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: More progressive stroke in one arm
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Dec 2013 (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.
To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.
Detailed description
This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Fluid | Experimental | Drug: 0.9% NaCl solution0.9% NaCl solution infusion: 100 ml/hr for three days. |
| No IV Fluid | No intervention | –Not receive any intravenous fluid but can consume oral fluid normally for three days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18-80 years
- NIHSS ≥ 1
- Diagnosis of acute ischemic stroke within 72 hours from stroke onset
- Enrollment into the study within 24 hours after hospital arrival
- Urine specific gravity level < 1.030
Key exclusion criteria (18 listed)
- Patients receiving > 40 ml/hr IV fluid infusion over 3 hours
- Acute ischemic stroke caused cardiogenic embolism
- Urine specific gravity ≥ 1.030
- Large cerebral infarction area
- NHISS ≥ 18
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 |
|---|---|---|
| 0.9% NaCl solutionAlso: Normal saline0.9% NaCl solution intravenous infusion: 100 ml/hr for three days. | Drug | IV Fluid |
Primary outcome
NIHSS ≤ 4
Time frame: day 7 after treatment or on the day of discharge
Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.
4 secondary outcomes
mRS ≤ 1
Time frame: day 7 after treatment or on the day of discharge
mRS ≤ 4
Time frame: at day 90
mRS ≤ 1
Time frame: at day 90
change of serum osmolarity
Time frame: at day 3 after treatment
Results and safety
The study was stopped early (reason given: More progressive stroke in one arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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.
Nijasri C Suwanwela, MD principal investigator
Chulalongkorn University
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 0.9% NaCl solution in people with Ischemic Stroke, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 4 Aug 2015. 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 Thailand. 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 was stopped early (reason given: More progressive stroke in one arm). Results are not available in the source record.
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?
NIHSS ≤ 4 (time frame: day 7 after treatment or on the day of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2015.