Cardiac DiseaseNCT05335902
Optic Nerve Sheath After Extracorporeal Circulation
An observational study of Cardiac Disease and Cardiac Valve Disease, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Disease, Cardiac Valve Disease
- What is being tested?
- ultrasound measurement of the optic nerve sheath diameter and MoCA test
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 22 Nov 2021to 1 Jun 2024
- Phase
- Observational
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Patients 18 years or older which are scheduled for heart surgery (coronary bypass, valve disease, thoracic aortic disease) in which cardiopulmonary bypass is used.
Who may be able to join
- heart surgery with use of cardiopulmonary bypass
Who cannot join
- pregnancy and lactation
- neurologic disorders
- hyperthyroidism
- optic nerve disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Extracorporeal Circulation During Cardiac Surgery on Optic Nerve Sheath Diameter
The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.
Read the detailed description
ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.
- Conditions
- Cardiac Disease, Cardiac Valve Disease
- Being tested
- ultrasound measurement of the optic nerve sheath diameter, MoCA test
- Keywords
- extracorporeal circulation, otpic nerve sheath diameter, postoperative cognitive disfunction, postoperative nausea and vomiting
- Medical subject headings
- Heart Diseases, Heart Valve Diseases, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurement of the optic nerve sheath diameterDiagnostic test
ultrasound measurement of the optic nerve sheath diameter
MoCA testDiagnostic test
MoCA test is a short bedside test for measuring cognitive disfunction
| Study group | Role | What they receive |
|---|---|---|
| standard cardiopulmonary bypass | patients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass Receives: Diagnostic Test: ultrasound measurement of the optic nerve sheath diameter; Diagnostic Test: MoCA test | |
| mini-cardiopulmonary bypass | patients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass Receives: Diagnostic Test: ultrasound measurement of the optic nerve sheath diameter; Diagnostic Test: MoCA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound measuring of optic nerve sheath diameter baseline
Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane
Measured: Before start of surgery
Ultrasound measuring of optic nerve sheath diameter end of surgery
Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane
Measured: 1 hour after the end of surgery
Ultrasound measuring of optic nerve sheath diameter day 1
Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane
Measured: day 1 after the surgery
Secondary outcomes (2)
postoperative cognitive disfunction measured with the MoCA test
MoCA test is a validated test for cognitive disfunction, especially in patients who are elderly than 60 years, the study is comparing the MoCA test values on the day before surgery with the values on day 3 after the surgery
Measured: on the day before surgery, on day 3 after the surgery
postoperative nausea and vomiting (PONV)
Postoperative nausea and vomiting is common after cardiac surgery, the occurrence of postoperative nausea and vomiting will be recorded
Measured: during the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start22 Nov 2021
- Primary completion1 Feb 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335902
- Sponsor's protocol ID
- UKC-MB-KME-59/21
- Status last verified
- Aug 2024
- First submitted
- 29 Oct 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
PubMed 8948560Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.
PubMed 10334272Zamvar V, Williams D, Hall J, Payne N, Cann C, Young K, Karthikeyan S, Dunne J. Assessment of neurocognitive impairment after off-pump and on-pump techniques for coronary artery bypass graft surgery: prospective randomised controlled trial. BMJ. 2002 Nov 30;325(7375):1268. doi: 10.1136/bmj.325.7375.1268.
PubMed 12458242Bayram H, Hidiroglu M, Cetin L, Kucuker A, Iriz E, Uguz E, Saglam F, Sener E. Comparing S-100 beta protein levels and neurocognitive functions between patients undergoing on-pump and off-pump coronary artery bypass grafting. J Surg Res. 2013 Jun 15;182(2):198-202. doi: 10.1016/j.jss.2012.10.047. Epub 2012 Nov 9.
PubMed 23183054Stroobant N, Van Nooten G, Belleghem Y, Vingerhoets G. Short-term and long-term neurocognitive outcome in on-pump versus off-pump CABG. Eur J Cardiothorac Surg. 2002 Oct;22(4):559-64. doi: 10.1016/s1010-7940(02)00409-8.
PubMed 12297172Riha H, Drabek T, Polisenska J, Brezina A. Postoperative nausea and vomiting in cardiac surgery. Eur J Anaesthesiol. 2009 Jun;26(6):535-6. doi: 10.1097/eja.0b013e328320a67a. No abstract available.
PubMed 19445063Gong Z, Li J, Zhong Y, Guan X, Huang A, Ma L. Effects of dexmedetomidine on postoperative cognitive function in patients undergoing coronary artery bypass grafting. Exp Ther Med. 2018 Dec;16(6):4685-4689. doi: 10.3892/etm.2018.6778. Epub 2018 Sep 19.
PubMed 30542420Styra R, Larsen E, Dimas MA, Baston D, Elgie-Watson J, Flockhart L, Lindsay TF. The effect of preoperative cognitive impairment and type of vascular surgery procedure on postoperative delirium with associated cost implications. J Vasc Surg. 2019 Jan;69(1):201-209. doi: 10.1016/j.jvs.2018.05.001. Epub 2018 Jun 22.
PubMed 29941317O'Dwyer C, Prough DS, Johnston WE. Determinants of cerebral perfusion during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 1996 Jan;10(1):54-64; quiz 65. doi: 10.1016/s1053-0770(96)80179-0.
PubMed 8634388Barbosa Nde F, Cardinelli DM, Ercole FF. Determinants of neurological complications with the use of extracorporeal circulation (ECC). Arq Bras Cardiol. 2010 Dec;95(6):e151-7. doi: 10.1590/s0066-782x2010001600022. No abstract available. English, Portuguese, Spanish.
PubMed 21271187Salameh A, Dhein S, Dahnert I, Klein N. Neuroprotective Strategies during Cardiac Surgery with Cardiopulmonary Bypass. Int J Mol Sci. 2016 Nov 21;17(11):1945. doi: 10.3390/ijms17111945.
PubMed 27879647Murphy GJ, Angelini GD. Side effects of cardiopulmonary bypass: what is the reality? J Card Surg. 2004 Nov-Dec;19(6):481-8. doi: 10.1111/j.0886-0440.2004.04101.x.
PubMed 15548178Hirleman E, Larson DF. Cardiopulmonary bypass and edema: physiology and pathophysiology. Perfusion. 2008 Nov;23(6):311-22. doi: 10.1177/0267659109105079.
PubMed 19454559Ottens TH, Hendrikse J, Slooter AJ, van Herwerden LA, Dieleman JM, van Dijk D. Low incidence of early postoperative cerebral edema after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2015;29(3):632-6. doi: 10.1053/j.jvca.2014.12.004. Epub 2014 Dec 3.
PubMed 25817849Harris DN, Oatridge A, Dob D, Smith PL, Taylor KM, Bydder GM. Cerebral swelling after normothermic cardiopulmonary bypass. Anesthesiology. 1998 Feb;88(2):340-5. doi: 10.1097/00000542-199802000-00011.
PubMed 9477053
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Extracorporeal Circulation During Cardiac Surgery on Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT05335902
- Acronym / sponsor ID
- UKC-MB-KME-59/21
- Conditions
- Cardiac Disease, Cardiac Valve Disease
- Keywords
- extracorporeal circulation, otpic nerve sheath diameter, postoperative cognitive disfunction, postoperative nausea and vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Apr 2022 (actual)
- 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 assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.
Detailed description
ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard cardiopulmonary bypass | – | Diagnostic Test: ultrasound measurement of the optic nerve sheath diameter, Diagnostic Test: MoCA testpatients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass |
| mini-cardiopulmonary bypass | – | Diagnostic Test: ultrasound measurement of the optic nerve sheath diameter, Diagnostic Test: MoCA testpatients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older which are scheduled for heart surgery (coronary bypass, valve disease, thoracic aortic disease) in which cardiopulmonary bypass is used.
Key inclusion criteria (1 listed)
- heart surgery with use of cardiopulmonary bypass
Key exclusion criteria (4 listed)
- pregnancy and lactation
- neurologic disorders
- hyperthyroidism
- optic nerve disorders
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 |
|---|---|---|
| ultrasound measurement of the optic nerve sheath diameterultrasound measurement of the optic nerve sheath diameter | Diagnostic test | mini-cardiopulmonary bypass, standard cardiopulmonary bypass |
| MoCA testMoCA test is a short bedside test for measuring cognitive disfunction | Diagnostic test | mini-cardiopulmonary bypass, standard cardiopulmonary bypass |
Primary outcome
Ultrasound measuring of optic nerve sheath diameter baseline
Time frame: Before start of surgery
Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane
Ultrasound measuring of optic nerve sheath diameter end of surgery
Time frame: 1 hour after the end of surgery
Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane
Ultrasound measuring of optic nerve sheath diameter day 1
Time frame: day 1 after the surgery
Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane
2 secondary outcomes
postoperative cognitive disfunction measured with the MoCA test
Time frame: on the day before surgery, on day 3 after the surgery
postoperative nausea and vomiting (PONV)
Time frame: during the first 24 hours 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 5 Aug 2024.
- Background: PubMed 8948560Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
- Background: PubMed 10334272Selnes OA, Goldsborough MA, Borowicz LM, McKhann GM. Neurobehavioural sequelae of cardiopulmonary bypass. Lancet. 1999 May 8;353(9164):1601-6. doi: 10.1016/S0140-6736(98)07576-X.
- Background: PubMed 12458242Zamvar V, Williams D, Hall J, Payne N, Cann C, Young K, Karthikeyan S, Dunne J. Assessment of neurocognitive impairment after off-pump and on-pump techniques for coronary artery bypass graft surgery: prospective randomised controlled trial. BMJ. 2002 Nov 30;325(7375):1268. doi: 10.1136/bmj.325.7375.1268.
- Background: PubMed 23183054Bayram H, Hidiroglu M, Cetin L, Kucuker A, Iriz E, Uguz E, Saglam F, Sener E. Comparing S-100 beta protein levels and neurocognitive functions between patients undergoing on-pump and off-pump coronary artery bypass grafting. J Surg Res. 2013 Jun 15;182(2):198-202. doi: 10.1016/j.jss.2012.10.047. Epub 2012 Nov 9.
- Background: PubMed 12297172Stroobant N, Van Nooten G, Belleghem Y, Vingerhoets G. Short-term and long-term neurocognitive outcome in on-pump versus off-pump CABG. Eur J Cardiothorac Surg. 2002 Oct;22(4):559-64. doi: 10.1016/s1010-7940(02)00409-8.
- Background: PubMed 19445063Riha H, Drabek T, Polisenska J, Brezina A. Postoperative nausea and vomiting in cardiac surgery. Eur J Anaesthesiol. 2009 Jun;26(6):535-6. doi: 10.1097/eja.0b013e328320a67a. No abstract available.
- Background: PubMed 30542420Gong Z, Li J, Zhong Y, Guan X, Huang A, Ma L. Effects of dexmedetomidine on postoperative cognitive function in patients undergoing coronary artery bypass grafting. Exp Ther Med. 2018 Dec;16(6):4685-4689. doi: 10.3892/etm.2018.6778. Epub 2018 Sep 19.
- Background: PubMed 29941317Styra R, Larsen E, Dimas MA, Baston D, Elgie-Watson J, Flockhart L, Lindsay TF. The effect of preoperative cognitive impairment and type of vascular surgery procedure on postoperative delirium with associated cost implications. J Vasc Surg. 2019 Jan;69(1):201-209. doi: 10.1016/j.jvs.2018.05.001. Epub 2018 Jun 22.
- Background: PubMed 8634388O'Dwyer C, Prough DS, Johnston WE. Determinants of cerebral perfusion during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 1996 Jan;10(1):54-64; quiz 65. doi: 10.1016/s1053-0770(96)80179-0.
- Background: PubMed 21271187Barbosa Nde F, Cardinelli DM, Ercole FF. Determinants of neurological complications with the use of extracorporeal circulation (ECC). Arq Bras Cardiol. 2010 Dec;95(6):e151-7. doi: 10.1590/s0066-782x2010001600022. No abstract available. English, Portuguese, Spanish.
- Background: PubMed 27879647Salameh A, Dhein S, Dahnert I, Klein N. Neuroprotective Strategies during Cardiac Surgery with Cardiopulmonary Bypass. Int J Mol Sci. 2016 Nov 21;17(11):1945. doi: 10.3390/ijms17111945.
- Background: PubMed 15548178Murphy GJ, Angelini GD. Side effects of cardiopulmonary bypass: what is the reality? J Card Surg. 2004 Nov-Dec;19(6):481-8. doi: 10.1111/j.0886-0440.2004.04101.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Cardiac Valve Disease, run by University Medical Centre Maribor at 1 site in Slovenia.
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 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 5 Aug 2024. 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 Slovenia. 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.
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?
Ultrasound measuring of optic nerve sheath diameter baseline (time frame: Before start of surgery). The study lists 3 primary outcomes in all. 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 NCT05335902, which also lists 26 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 5 Aug 2024.