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Brain TumorPhase 4NCT02713087

Vasopressor Effects in Anesthetized Patients

A Phase 4 study testing Ephedrine and Phenylephrine in people with Brain Tumor, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors Sponsor-investigator: Klaus Ulrik Koch M.D. Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark Objective: To investigate whether… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Brain Tumor
What is being tested?
Ephedrine and Phenylephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteDenmark
Study dates
Sep 2015to Nov 2017
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images)
  • ASA (American Society of Anesthesiologist) status 1-3 (27)
  • Written informed consent from participating patients

Who cannot join

  • Age younger than 18 yrs. or older than 75 yrs.
  • Pregnancy or nursing (negative pregnancy blood test)
  • History of allergic reactions to phenylephrine or ephedrine
  • eGFR < 60ml/min/1.73m2

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Aarhus University Hospital

    Aarhus, Jylland, 8000

Other trials in Denmark

About this study

Official title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors

Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors

Sponsor-investigator: Klaus Ulrik Koch M.D.

Read more

Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark

Objective:

To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with brain tumors. Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine

Method:

Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are infused intravenously under general anesthesia. MRI is performed in 20 patients before and after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS monitoring will be used in either scanner. After scanning patients are transported to the operating theatre and the craniotomy is performed. After removal of the bone flap subdural ICP is measured and recorded.

MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured.

Data from the proposed studies will add substantial new knowledge to the investigators current understanding of the effects of vasopressors on cerebral circulation. This information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the choice of the optimal method to manage cerebral perfusion pressure during craniotomy for brain tumor.

Read the detailed description

Background:

During brain tumor surgery the main objective for the neuroanesthesiologist is to maintain a low intracranial pressure (ICP) and a sufficient cerebral perfusion pressure (CPP) (CPP = mean arterial blood pressure [MABP] - ICP) to ensure adequate cerebral oxygenation. Brain tumors are often associated with edema and increased ICP and a specific recommendation for CPP thresholds during brain tumor surgery does not exist. In daily practice vasopressors are used to increase MABP to maintain a CPP between 50-70 mmHg in accordance with current guidelines for management of patients with traumatic brain pathology.

However, recent studies show that arterial blood pressure correlates only poorly with microcirculatory flow. Elevation of blood pressure may result in reduced capillary perfusion and oxygen delivery despite reaching resuscitation end-points with CPP within 50-70 mmHg. This is supported by an experimental study demonstrating vasopressor-induced mismatch between cerebral perfusion and oxygenation, possibly due to microvascular heterogeneity, as suggested by the authors. In addition, recent studies in healthy anesthetized subjects demonstrate that, despite an increase in MABP, cerebral oxygenation simultaneously decreases after phenylephrine but remains unchanged after administration of ephedrine. Thus, increasing CPP with vasopressors may lead to paradoxical microcirculatory response with vasopressor-induced tissue hypo-perfusion and hindered tissue oxygenation.

Brain microcirculation is the primary site of oxygen exchange. The investigators have recently proposed that red blood cell capillary transit time heterogeneity (CTTH) may affect tissue oxygen tension in patients with ischemic stroke, subarachnoid hemorrhage and traumatic brain injury. According to this theory capillary compression due to edema and elevated ICP may cause redistribution of capillary flows into patterns with functional shunting of oxygenated blood through the cerebral capillary bed. This capillary dysfunction may further hinder oxygen diffusion into cerebral tissue and ultimately cause cerebral ischemic damage. The dissimilar effects of phenylephrine and ephedrine on cerebral oxygenation may be caused by a different influence on brain capillary perfusion or alternated CTTH. Currently there are no studies available on the effects of commonly used vasopressors on brain microcirculation and oxygenation in patients undergoing craniotomy for brain tumors.

Hypothesis:

The use of phenylephrine is associated with a reduction in brain oxygenation and microcirculation compared to ephedrine in anesthetized patients with brain tumors.

Specifically the investigators hypothesize that:

  1. In peritumoral areas phenylephrine is associated with a local increase in CBF, increased CTTH, decreased oxygen extraction fraction and increase in the BOLD signal compared to ephedrine
  2. Phenylephrine is associated with a reduction in oxygen extraction fraction (OEF) compared to ephedrine

Materials and methods:

Overall Study design:

Double blinded controlled randomized clinical trial.

Studies:

Study 1 (MRI study). 20 patients are randomized to infusion of either ephedrine or phenylephrine until MAP >60 mmHg

Study 2 (PET study). 20 patients are randomized to infusion of either ephedrine or phenylephrine until MAP >60mmHg

MRI and PET measurements are performed after induction of general anesthesia with propofol and remifentanil. The MRI or PET sequence is then performed before administration of study-drug and again after the infusion of either phenylephrine or ephedrine results in MAP > 60mmHg. Depth of anesthesia is monitored with BIS in both studies to ensure equal level of anesthetic depth in the two groups. NIRS is monitored in both studies to compare measurements of brain oxygenation determined by PET/CT. NIRS measurements are not possible during MR scan and will be measured either before or after the scan. BIS and NIRS are registered in each patients case report form (CRF). After the MRI/PET study the patient is transported to the operating theatre and the craniotomy is performed. After removal of the bone-flap, subdural ICP is measured and recorded as previously described.

The overall experimental setup is the same for the two studies. The patient is anesthetized and MRI or PET is performed before and after administration of a study-drug. The specific MRI and PET protocols are mentioned below

  • MRI protocol
  • Conventional MRI sequences on a high quality research scanner
  • Diffusion-weighted MRI incl. diffusion kurtosis imaging
  • Perfusion-weighted MRI before and after ephedrine or phenylephrine, respectively
  • The duration of the entire MRI scan is estimated to 60 min. Two and a half standard doses of gadolinium MRI contrast are administered ( 0.25 mmol/kg).
  • PET protocol
  • Cerebral Blood Flow (CBF): 500 MBq of [15O]H2O is injected intravenously. At injection a three minute PET image acquisition of the brain is started together with arterial blood sampling (also three minutes) with an automated blood radioactivity sampler that draws 7 ml blood per minute. The PET acquisition is done on a Siemens High Resolution Research Tomograph (HRRT) in list mode.
  • Cerebral Metabolic Rate of Oxygen (CMRO2): 1000 MBq of [15O]O2 is inhaled and immediately exhaled. At inhalation PET acquisition and blood sampling are performed with protocols identical to CBF.
  • During each scan session oxygen saturation and haemoglobin concentration will be measured.

Physiological parameters (blood pressure and ICP) are documented in the CRF corresponding to each patient. BIS and NIRS data are stored on a portable computer and subjected to offline analysis. Parametric and non-parametric statistics will be used to compare MRI and PET. Physiological data will be recorded during stimulation with study-drugs. The sample size is based on previous publications where a MRI protocol was performed before and after drug administration in anesthetized patients. The exact form of applied statistics are not yet decided. This kind of study with new parameters from MRI and PET has never been done and statistical help will be consulted along the process.

Perspectives:

Data from the proposed studies will add to the investigators understanding of the cerebral microcirculation and its importance for brain oxygenation in patients of different age and comorbidity. Meanwhile, the study will provide new insights into the effects of vasopressors on the cerebral circulation. The study will thus provide direct observations for the investigators recent efforts to understand the role of the microcirculation in neurological disorders, and help the investigators chose the optimal method to manage CPP during craniotomy for brain tumor.

These insights may have implications for the future management of increased intracranial pressure and CPP after TBI and SAH.

Applicant´s part in the research:

Applicant Klaus Ulrik Koch is sponsor-investigator on this study and the responsible person of finishing the PhD thesis.

Conditions
Brain Tumor
Being tested
Ephedrine, Phenylephrine
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EphedrineDrug

    Infusion of Ephedrine 2mg/ml until MAP above 60 mmHg or until MAP has raised 20%

  • PhenylephrineDrug

    Infusion of Phenylephrine 0,1mg/ml until MAP above 60 mmHg or until MAP has raised 20%

Study groups in NCT02713087
Study groupRoleWhat they receive
EphedrineActive comparatorNot described
Receives: Drug: Ephedrine
PhenylephrineActive comparatorNot described
Receives: Drug: Phenylephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Capillary Transit Time Heterogeneity

    Measured: 4 Years

Secondary outcomes (1)
  1. Cerebral Metabolic Rate of Oxygen

    Measured: 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713087
Sponsor's protocol ID
Vasobrain01
Status last verified
Oct 2016
First submitted
10 Feb 2016
Last updated
26 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rasmussen M, Bundgaard H, Cold GE. Craniotomy for supratentorial brain tumors: risk factors for brain swelling after opening the dura mater. J Neurosurg. 2004 Oct;101(4):621-6. doi: 10.3171/jns.2004.101.4.0621.

    PubMed 15481716
  • Rasmussen M, Juul N, Christensen SM, Jonsdottir KY, Gyldensted C, Vestergaard-Poulsen P, Cold GE, Ostergaard L. Cerebral blood flow, blood volume, and mean transit time responses to propofol and indomethacin in peritumor and contralateral brain regions: perioperative perfusion-weighted magnetic resonance imaging in patients with brain tumors. Anesthesiology. 2010 Jan;112(1):50-6. doi: 10.1097/ALN.0b013e3181c38bd3.

    PubMed 19952725
  • Rasmussen M, Ostergaard L, Juul N, Gyldensted C, Poulsen PV, Cold GE. Do indomethacin and propofol cause cerebral ischemic damage? Diffusion-weighted magnetic resonance imaging in patients undergoing craniotomy for brain tumors. Anesthesiology. 2004 Oct;101(4):872-8. doi: 10.1097/00000542-200410000-00011.

    PubMed 15448519
  • Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

    PubMed 19534818
  • Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. XIV. Hyperventilation. J Neurotrauma. 2007;24 Suppl 1:S87-90. doi: 10.1089/neu.2007.9982. No abstract available.

    PubMed 17511553
  • Boerma EC, Ince C. The role of vasoactive agents in the resuscitation of microvascular perfusion and tissue oxygenation in critically ill patients. Intensive Care Med. 2010 Dec;36(12):2004-18. doi: 10.1007/s00134-010-1970-x. Epub 2010 Sep 2.

    PubMed 20811874
  • Sahuquillo J, Amoros S, Santos A, Poca MA, Panzardo H, Dominguez L, Pedraza S. Does an increase in cerebral perfusion pressure always mean a better oxygenated brain? A study in head-injured patients. Acta Neurochir Suppl. 2000;76:457-62. doi: 10.1007/978-3-7091-6346-7_95.

    PubMed 11450067
  • Hahn GH, Hyttel-Sorensen S, Petersen SM, Pryds O, Greisen G. Cerebral effects of commonly used vasopressor-inotropes: a study in newborn piglets. PLoS One. 2013 May 20;8(5):e63069. doi: 10.1371/journal.pone.0063069. Print 2013.

    PubMed 23700412
  • Nissen P, Brassard P, Jorgensen TB, Secher NH. Phenylephrine but not ephedrine reduces frontal lobe oxygenation following anesthesia-induced hypotension. Neurocrit Care. 2010 Feb;12(1):17-23. doi: 10.1007/s12028-009-9313-x.

    PubMed 19957053
  • Meng L, Cannesson M, Alexander BS, Yu Z, Kain ZN, Cerussi AE, Tromberg BJ, Mantulin WW. Effect of phenylephrine and ephedrine bolus treatment on cerebral oxygenation in anaesthetized patients. Br J Anaesth. 2011 Aug;107(2):209-17. doi: 10.1093/bja/aer150. Epub 2011 Jun 3.

    PubMed 21642644
  • Soeding PF, Hoy S, Hoy G, Evans M, Royse CF. Effect of phenylephrine on the haemodynamic state and cerebral oxygen saturation during anaesthesia in the upright position. Br J Anaesth. 2013 Aug;111(2):229-34. doi: 10.1093/bja/aet024. Epub 2013 Mar 21.

    PubMed 23518801
  • Jespersen SN, Ostergaard L. The roles of cerebral blood flow, capillary transit time heterogeneity, and oxygen tension in brain oxygenation and metabolism. J Cereb Blood Flow Metab. 2012 Feb;32(2):264-77. doi: 10.1038/jcbfm.2011.153. Epub 2011 Nov 2.

    PubMed 22044867
  • Ostergaard L, Jespersen SN, Mouridsen K, Mikkelsen IK, Jonsdottir KY, Tietze A, Blicher JU, Aamand R, Hjort N, Iversen NK, Cai C, Hougaard KD, Simonsen CZ, Von Weitzel-Mudersbach P, Modrau B, Nagenthiraja K, Riisgaard Ribe L, Hansen MB, Bekke SL, Dahlman MG, Puig J, Pedraza S, Serena J, Cho TH, Siemonsen S, Thomalla G, Fiehler J, Nighoghossian N, Andersen G. The role of the cerebral capillaries in acute ischemic stroke: the extended penumbra model. J Cereb Blood Flow Metab. 2013 May;33(5):635-48. doi: 10.1038/jcbfm.2013.18. Epub 2013 Feb 27.

    PubMed 23443173
  • Ostergaard L, Aamand R, Karabegovic S, Tietze A, Blicher JU, Mikkelsen IK, Iversen NK, Secher N, Engedal TS, Anzabi M, Jimenez EG, Cai C, Koch KU, Naess-Schmidt ET, Obel A, Juul N, Rasmussen M, Sorensen JC. The role of the microcirculation in delayed cerebral ischemia and chronic degenerative changes after subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2013 Dec;33(12):1825-37. doi: 10.1038/jcbfm.2013.173. Epub 2013 Sep 25.

    PubMed 24064495
  • Ostergaard L, Engedal TS, Aamand R, Mikkelsen R, Iversen NK, Anzabi M, Naess-Schmidt ET, Drasbek KR, Bay V, Blicher JU, Tietze A, Mikkelsen IK, Hansen B, Jespersen SN, Juul N, Sorensen JC, Rasmussen M. Capillary transit time heterogeneity and flow-metabolism coupling after traumatic brain injury. J Cereb Blood Flow Metab. 2014 Oct;34(10):1585-98. doi: 10.1038/jcbfm.2014.131. Epub 2014 Jul 23.

    PubMed 25052556

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ephedrine and Phenylephrine in people with Brain Tumor, run by University of Aarhus at 1 site in Denmark.

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 3 inclusion and 4 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 Oct 2018. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Capillary Transit Time Heterogeneity (time frame: 4 Years). 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 NCT02713087, which also lists 27 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 Oct 2018.

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