Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Mattias Danielson, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01755338
First received: December 18, 2012
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Aortic Stenosis
Drug: methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative/intraoperative insulin demand [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylprednisolone
Methylprednisolone i.v. 15mg/kg x 1 intraoperative
Drug: methylprednisolone
15mg/kg i.v.
Other Name: Solu Medrol
Placebo Comparator: Placebo (NaCl)
Placebo i.v., x1, intraoperative

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.

20 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective aortic surgery +/- coronary artery bypass grafting (CABG)

Exclusion Criteria:

  • coagulopathy
  • preoperative neurologic deficit
  • uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755338

Contacts
Contact: Mattias Danielson, MD +46313427452 mattias.danielsson@vgregion.se
Contact: Sven Erik Ricksten, Professor +46313427433 sven-erik.ricksten@aniv.gu.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, VGR, Sweden, 41345
Contact: Mattias Danielson, MD    +46313427452    mattias.danielsson@vgregion.se   
Principal Investigator: Mattias Danielson, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Mattias Danielson, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01755338     History of Changes
Other Study ID Numbers: 2012-004232-37
Study First Received: December 18, 2012
Last Updated: March 5, 2015
Health Authority: Sweden: Swedish Research Council

Keywords provided by Sahlgrenska University Hospital, Sweden:
cerebrospinal fluid
inflammatory markers
heart surgery
neuronal damage
blood brain barrier

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015