Aortic StenosisNCT01755338
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
A study testing Methylprednisolone in people with Aortic Stenosis, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2012to Feb 2017
- Phase
- Interventional
- 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
- elective aortic surgery +/- coronary artery bypass grafting (CABG)
Who cannot join
- coagulopathy
- preoperative neurologic deficit
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
Read the detailed description
In a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids.
30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood brain barrier function (alb).
- Conditions
- Aortic Stenosis
- Being tested
- Methylprednisolone, Placebo
- Keywords
- cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol
Methylprednisolone 15mg/kg
PlaceboDrug
Also called Sodium Chloride
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement Receives: Drug: Methylprednisolone |
| Placebo (NaCl) | Placebo comparator | Placebo i.v., x1, intraoperative Aortic Valve Replacement Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
Measured: 24h after surgery
Secondary outcomes (1)
Postoperative/intraoperative insulin demand
Measured: 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Danielson, Sahlgrenska University Hospital
- Investigators
- Sven-Erik Ricksten, Professor, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755338
- Sponsor's protocol ID
- 2012-004232-37
- Status last verified
- May 2017
- First submitted
- 18 Dec 2012
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danielson M, Reinsfelt B, Westerlind A, Zetterberg H, Blennow K, Ricksten SE. Effects of methylprednisolone on blood-brain barrier and cerebral inflammation in cardiac surgery-a randomized trial. J Neuroinflammation. 2018 Sep 27;15(1):283. doi: 10.1186/s12974-018-1318-y.
PubMed 30261896
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT01755338
- Acronym / sponsor ID
- 2012-004232-37
- Conditions
- Aortic Stenosis
- Keywords
- cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Dec 2012 (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 purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
Detailed description
In a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids.
30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood brain barrier function (alb).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneMethylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement |
| Placebo (NaCl) | Placebo comparator | Drug: PlaceboPlacebo i.v., x1, intraoperative Aortic Valve Replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective aortic surgery +/- coronary artery bypass grafting (CABG)
Key exclusion criteria (3 listed)
- coagulopathy
- preoperative neurologic deficit
- uncontrolled hypertension
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 |
|---|---|---|
| MethylprednisoloneAlso: Solu-MedrolMethylprednisolone 15mg/kg | Drug | Methylprednisolone |
| PlaceboAlso: Sodium ChloridePlacebo | Drug | Placebo (NaCl) |
Primary outcome
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
Time frame: 24h after surgery
1 secondary outcome
Postoperative/intraoperative insulin demand
Time frame: 24h after surgery
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 1 Jun 2017.
- Derived from this study: PubMed 30261896Danielson M, Reinsfelt B, Westerlind A, Zetterberg H, Blennow K, Ricksten SE. Effects of methylprednisolone on blood-brain barrier and cerebral inflammation in cardiac surgery-a randomized trial. J Neuroinflammation. 2018 Sep 27;15(1):283. doi: 10.1186/s12974-018-1318-y.
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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.
Sven-Erik Ricksten, Professor study chair
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone in people with Aortic Stenosis, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 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 1 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb (time frame: 24h after surgery). 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 NCT01755338, which also lists 1 linked publication.
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 1 Jun 2017.