Cognitive DeclineNCT03186846
Volume Optimisation and Cognitive Function in Major Abdominal Surgery
A study testing multimodal monitoring in people with Cognitive Decline, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In the last 25 years, there has been a lot of attention directed on reducing perioperative morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation of patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- multimodal monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2017to 1 Aug 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 2-3 patients,
- > 18 years
- signed written consent for anesthesia and study participation
- Major abdominal surgery (stomach and intestin resection)
- epidural catheter insertion
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Volume Optimisation on Cognitive Function in Major Abdominal Surgery
In the last 25 years, there has been a lot of attention directed on reducing perioperative morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation of patients. Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to micro circulation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There is increasing evidence that long-term outcome is improved by goal-directed optimisation of hemodynamic parameters (optimisation of stroke volume and cardiac output by fluids and inotropic and vasoactive drugs). Besides, new monitoring possibilities (depth of anaesthesia and cerebral and tissue oxygenation monitors) and adherence to protocols have proved beneficial in reducing morbidity cognitive dysfunction.
However, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values, restrictive fluid management) should be. Secondly, all new methods were used separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on occurrence of cognitive dysfunction. All gathered data indicate that the combined use of new methods with adherence to an appropriate protocol might radically improve the perioperative management and outcome of high-risk surgical patients.
The present study tests the hypothesis that intraoperative multimodal monitoring with hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen saturation will reduce cognitive dysfunction.
Read the detailed description
BACKGROUND There is increasing evidence that intraoperative aesthetic management influences outcomes. (5). Besides this the occurrence of low MAP, low minimum alveolar concentration (MAC) and low bispectral index (BIS) increased hospital stay and mortality.
Conventional intraoperative monitoring can result in occult low levels of blood flow and oxygen delivery that lead to complications that only occur days or weeks following surgery and give false re-assurance to the anaesthetist that he or she is doing a "good job". Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to microcirculation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There are more and more trials showing that introduction of new monitors and treatment protocols with predefined treatment limits or targets (goal-directed optimisation of hemodynamic parameters) improves long-term patient outcome and reduces morbidity and mortality by over 50%. Several studies have shown benefit when individualised; targeted oxygen delivery algorithms incorporating both fluid resuscitation and vasoactive drugs were used with high-risk surgical patients. The measurement of regional cerebral oxygen saturation can predict cognitive dysfunction after cardiac surgery. BIS monitoring facilitates anaesthetic titration, and reduced anaesthetic exposure and decreased the risk of postoperative cognitive dysfunction. There is reduction in strokes, less mechanical ventilation and shorter length of stay (LOS) with the use of INVOS.
However, all new methods have been studied separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on mortality and occurrence of complications, including cognitive decline. All gathered data indicate that the combined use of new methods (assessment of fluid status, depth of anaesthesia and tissue oxygenation) with adherence to appropriate protocol might radically improve perioperative management and outcome of high-risk surgical patients.
Besides, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values) should be. Lately, studies have shown that optimising cardiac output and oxygen delivery to higher (supra-normal) values intra- and postoperatively did not affect post-operative complications rate, intensive care unit stay or hospital length of stay. Probably the target should be maintaining patient's blood flow and oxygen delivery at preinduction levels. The question was also raised in fluid management. Liberal approach can lead to oedema of the intestines and other tissues, which may be responsible for poor tissue healing and other complications. In abdominal surgery, protocol-based fluid restriction reduced the incidence of perioperative complications such as cardiopulmonary events and disturbances of bowel motility while improving wound and anastomotic healing and reducing hospital stay in comparison to liberal fluid management. One of the trials has shown 52% lower rate of major postoperative complications in restrictive group than in the conventional group.
HYPOTHESIS The present study tests the hypothesis that intraoperative multimodal monitoring with hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen saturation will reduce cognitive decline.
- Conditions
- Cognitive Decline
- Being tested
- multimodal monitoring, placebo
- Keywords
- cognitive decline, hemodynamic monitoring, LIDCO, INVOS, BIS, brain injury biomarkers
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal monitoringDevice
Also called LiDCO Rapid, unilateral INVOS, unilateral BIS
LiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. • Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.
placeboDevice
Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.
| Study group | Role | What they receive |
|---|---|---|
| multimodal monitoring | Active comparator | LiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy. Receives: Device: multimodal monitoring |
| placebo | Active comparator | No multimodal monitoring will be applied in control group. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline assessment change
Blood samples for determination of brain injury biomarkers (NSE, S 100, GFAP, TAU, UCH-L1, MMP-9, miRNA, apo E4) before and at the end of operation.
Cognitive function testing (Mini mental test): before the operation and on day 2 after the surgery.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Oct 2017
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alenka Spindler-Vesel, University Medical Centre Ljubljana
- Investigators
- Alenka Spindler Vesel, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186846
- Sponsor's protocol ID
- KME 21/11/16
- Status last verified
- Jan 2021
- First submitted
- 18 May 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
PubMed 16356219Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.
PubMed 3191758Green D, Paklet L. Latest developments in peri-operative monitoring of the high-risk major surgery patient. Int J Surg. 2010;8(2):90-9. doi: 10.1016/j.ijsu.2009.12.004. Epub 2010 Jan 14.
PubMed 20079469Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.
PubMed 10213716Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.
PubMed 12510037Walsh SR, Tang T, Bass S, Gaunt ME. Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract. 2008 Mar;62(3):466-70. doi: 10.1111/j.1742-1241.2007.01516.x. Epub 2007 Nov 21.
PubMed 18031528Abbas SM, Hill AG. Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia. 2008 Jan;63(1):44-51. doi: 10.1111/j.1365-2044.2007.05233.x.
PubMed 18086070Gurgel ST, do Nascimento P Jr. Maintaining tissue perfusion in high-risk surgical patients: a systematic review of randomized clinical trials. Anesth Analg. 2011 Jun;112(6):1384-91. doi: 10.1213/ANE.0b013e3182055384. Epub 2010 Dec 14.
PubMed 21156979Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PubMed 19837807Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
PubMed 19101265Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
PubMed 23027226Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
PubMed 17179242Bisgaard J, Gilsaa T, Ronholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17.
PubMed 22897633Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.
PubMed 14578723Holte K, Kehlet H. Fluid therapy and surgical outcomes in elective surgery: a need for reassessment in fast-track surgery. J Am Coll Surg. 2006 Jun;202(6):971-89. doi: 10.1016/j.jamcollsurg.2006.01.003. No abstract available.
PubMed 16735213
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Volume Optimisation on Cognitive Function in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03186846
- Acronym / sponsor ID
- KME 21/11/16
- Conditions
- Cognitive Decline
- Keywords
- cognitive decline, hemodynamic monitoring, LIDCO, INVOS, BIS, brain injury biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 Jun 2017 (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.
In the last 25 years, there has been a lot of attention directed on reducing perioperative morbidity and mortality by improving intraoperative monitoring and hemodynamic optimisation of patients. Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to micro circulation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There is increasing evidence that long-term outcome is improved by goal-directed optimisation of hemodynamic parameters (optimisation of stroke volume and cardiac output by fluids and inotropic and vasoactive drugs). Besides, new monitoring possibilities (depth of anaesthesia and cerebral and tissue oxygenation monitors) and adherence to protocols have proved beneficial in reducing morbidity cognitive dysfunction.
However, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values, restrictive fluid management) should be. Secondly, all new methods were used separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on occurrence of cognitive dysfunction. All gathered data indicate that the combined use of new methods with adherence to an appropriate protocol might radically improve the perioperative management and outcome of high-risk surgical patients.
The present study tests the hypothesis that intraoperative multimodal monitoring with hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen saturation will reduce cognitive dysfunction.
Detailed description
BACKGROUND There is increasing evidence that intraoperative aesthetic management influences outcomes. (5). Besides this the occurrence of low MAP, low minimum alveolar concentration (MAC) and low bispectral index (BIS) increased hospital stay and mortality.
Conventional intraoperative monitoring can result in occult low levels of blood flow and oxygen delivery that lead to complications that only occur days or weeks following surgery and give false re-assurance to the anaesthetist that he or she is doing a "good job". Advanced monitoring devices and new parameters have shifted the focus of anaesthesia management from macro- to microcirculation with the emphasis on the determinants of oxygen delivery and tissue oxygenation. There are more and more trials showing that introduction of new monitors and treatment protocols with predefined treatment limits or targets (goal-directed optimisation of hemodynamic parameters) improves long-term patient outcome and reduces morbidity and mortality by over 50%. Several studies have shown benefit when individualised; targeted oxygen delivery algorithms incorporating both fluid resuscitation and vasoactive drugs were used with high-risk surgical patients. The measurement of regional cerebral oxygen saturation can predict cognitive dysfunction after cardiac surgery. BIS monitoring facilitates anaesthetic titration, and reduced anaesthetic exposure and decreased the risk of postoperative cognitive dysfunction. There is reduction in strokes, less mechanical ventilation and shorter length of stay (LOS) with the use of INVOS.
However, all new methods have been studied separately and there is a lack of studies to show the effect of combined (multimodal) monitoring on mortality and occurrence of complications, including cognitive decline. All gathered data indicate that the combined use of new methods (assessment of fluid status, depth of anaesthesia and tissue oxygenation) with adherence to appropriate protocol might radically improve perioperative management and outcome of high-risk surgical patients.
Besides, questions are raised what the optimal goals (healthy population derived normal values, preoperative values, maximal values) should be. Lately, studies have shown that optimising cardiac output and oxygen delivery to higher (supra-normal) values intra- and postoperatively did not affect post-operative complications rate, intensive care unit stay or hospital length of stay. Probably the target should be maintaining patient's blood flow and oxygen delivery at preinduction levels. The question was also raised in fluid management. Liberal approach can lead to oedema of the intestines and other tissues, which may be responsible for poor tissue healing and other complications. In abdominal surgery, protocol-based fluid restriction reduced the incidence of perioperative complications such as cardiopulmonary events and disturbances of bowel motility while improving wound and anastomotic healing and reducing hospital stay in comparison to liberal fluid management. One of the trials has shown 52% lower rate of major postoperative complications in restrictive group than in the conventional group.
HYPOTHESIS The present study tests the hypothesis that intraoperative multimodal monitoring with hemodynamic optimisation, BIS-guided anaesthesia and maintenance of optimal cerebral oxygen saturation will reduce cognitive decline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multimodal monitoring | Active comparator | Device: multimodal monitoringLiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy. |
| placebo | Active comparator | Device: placeboNo multimodal monitoring will be applied in control group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA 2-3 patients,
- > 18 years
- signed written consent for anesthesia and study participation
- Major abdominal surgery (stomach and intestin resection)
- epidural catheter insertion
Key exclusion criteria (1 listed)
- pregnant women
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 |
|---|---|---|
| multimodal monitoringAlso: LiDCO Rapid, unilateral INVOS, unilateral BISLiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. • Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy. | Device | multimodal monitoring |
| placeboBefore the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy. | Device | placebo |
Primary outcome
Cognitive decline assessment change
Time frame: three days
Blood samples for determination of brain injury biomarkers (NSE, S 100, GFAP, TAU, UCH-L1, MMP-9, miRNA, apo E4) before and at the end of operation. Cognitive function testing (Mini mental test): before the operation and on day 2 after the 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 20 Jan 2021.
- Background: PubMed 16356219Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Background: PubMed 3191758Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.
- Background: PubMed 20079469Green D, Paklet L. Latest developments in peri-operative monitoring of the high-risk major surgery patient. Int J Surg. 2010;8(2):90-9. doi: 10.1016/j.ijsu.2009.12.004. Epub 2010 Jan 14.
- Background: PubMed 10213716Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.
- Background: PubMed 12510037Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.
- Background: PubMed 18031528Walsh SR, Tang T, Bass S, Gaunt ME. Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract. 2008 Mar;62(3):466-70. doi: 10.1111/j.1742-1241.2007.01516.x. Epub 2007 Nov 21.
- Background: PubMed 18086070Abbas SM, Hill AG. Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia. 2008 Jan;63(1):44-51. doi: 10.1111/j.1365-2044.2007.05233.x.
- Background: PubMed 21156979Gurgel ST, do Nascimento P Jr. Maintaining tissue perfusion in high-risk surgical patients: a systematic review of randomized clinical trials. Anesth Analg. 2011 Jun;112(6):1384-91. doi: 10.1213/ANE.0b013e3182055384. Epub 2010 Dec 14.
- Background: PubMed 19837807Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
- Background: PubMed 19101265Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
- Background: PubMed 23027226Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
- Background: PubMed 17179242Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
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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.
Alenka Spindler Vesel, MD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal monitoring in people with Cognitive Decline, run by University Medical Centre Ljubljana 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 5 inclusion and 1 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 20 Jan 2021. 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?
Cognitive decline assessment change (time frame: three days). 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 NCT03186846, which also lists 19 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 20 Jan 2021.