Postoperative Cognitive DysfunctionPhase 4CDCSNCT02767713
Cognitive Dysfunction Following Cardiac Surgery
A Phase 4 study testing Dexamethasone in people with Postoperative Cognitive Dysfunction, run by Clinical Hospital Center, Split.
Trial summary
Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2016
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants undergoing cardiac surgery: coronary artery bypass grafting, heart valve surgery or a combined procedure,
- Procedure must be elective
Who cannot join
- Symptomatic cerebrovascular disease,
- Cerebrovascular incident in last 3 years,
- Neurodegenerative disease,
- Psychiatric disease,
- Visual, hearing or motor impairment interfering with cognitive testing,
- Carotid artery stenosis ( ≥50%),
Show all 25Show fewer
- Myocardial infarction within last 3 months,
- Left ventricular ejection fraction of ≤35%,
- Previous cardiac or carotid surgery,
- Uncontrolled systemic hypertension (blood pressure≥180/110 mmHg),
- Corticosteroid-dependent asthma,
- Chronic obstructive pulmonary disease (COPD),
- Malignancy, liver disease (aspartate transaminase (AST), alanine transaminase (ALT) or bilirubin ˃1.5x above reference range),
- Kidney disease (serum creatinine ˃1.7 mg/dl or blood urea nitrogen ˃50 mg/dL),
- Uncontrolled diabetes mellitus (postprandial glucose ˃200 mg/dL or hemoglobin A1c ˃9%),
- Endocrine and metabolic diseases, requiring steroid treatment longer than 7 days in the past year,
- Alcohol or controlled substance abuse,
- Individuals without primary school education,
- Preoperative C reactive protein ˃0.5 mg/dL,
- Preoperative white blood cell count <3 x109/L or ˃11 x109/L,
- Preoperative Mini mental score <26 points,
- Preoperative Beck's depression inventory score ˃ 19 points,
- Intraoperative plan change (conversion from "off-pump" to "on-pump" and vice versa),
- Need for deep hypothermic circulatory arrest,
- Additional corticosteroid treatment throughout the study period.
About this study
Official title: The Role of Inflammatory and Stress Response in the Pathogenesis of Cognitive Dysfunction After Cardiac Surgery
Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). The investigators focused on the role of inflammatory and stress response to surgical procedure as potential factors involved in the pathogenesis of cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated following cortisol levels and its daily variations. The degree of cognitive dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on the development of POCD was compared with control group that received normal saline.
Read the detailed description
This is a prospective, randomized, double blind, controlled trial. Following detailed past medical history assessment, two days before the surgical procedure neurocognitive function tests, depression and anxiety tests were carried out to assess the participants. Neurocognitive and anxiety tests were repeated on the 6th day after surgical procedure. A battery of tests lasting approximately 40 minutes were administered by a trained neuropsychologist from the Clinical Hospital Center, Split in a standardized fashion, at the same time of the day (10:00 AM) and in the same room at the Cardiac surgery ward. The investigators used a validated battery of tests which enabled the assessment of psychomotor speed, visual-motor coordination, concentration, attention, short-term memory and aspects of executive functioning. The evaluation was based on the following tests: Mini Mental State Examination (MMSE), Wechsler Memory Scale (WMS I \& II), Trail Making Test (TMT A \& B), Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association Test (COWAT) and PsychE computer test. All of the tests except TMT A \& B have alternate forms. Croatian versions of Beck Depression Inventory-Second Edition (BDI II) and State-Trait Anxiety Inventory (STAI-M) were used for preoperative depression and trait and state anxiety assessment, respectively.
One day before the surgery (08:00 AM) blood samples were collected for determination of levels of S100β protein, cortisol and other routine laboratory parameters (white blood cell count (WBC), hematocrit, creatinine, glucose, albumin, sodium, potassium, C reactive protein (CRP), Troponin I hs).
Participants were randomized into two groups to receive either intravenous dexamethasone 0.1 mg/kg or the same volume of normal saline i.v. 10 hours before the surgery. Random sequence generator was used to determine participant allocation.
Anesthesia in all patients was based on fentanyl, midazolam, vecuronium and sevoflurane. The depth of anesthesia was monitored using bispectral index (BIS). During cardiopulmonary bypass alpha-stat technique was used with the maintenance of normothermia (35.5-36.5°C) or spontaneous hypothermia (up to 32°C). With the off-pump technique, the core temperature was maintained between 36 and 37°C. Surgical technique was standardized. Routine hemodynamic monitoring was performed throughout the surgery and continued on the first postoperative day. Plasma levels of S100β protein were determined 6 h and 30 h following the end of on-pump surgery, and 3 h following the end of off-pump surgery. C reactive protein levels and other routine laboratory parameters were measured from blood samples collected 1 h, 4 h and 12 h postoperatively. On the first postoperative day blood samples were collected at 08:00 AM to determine cortisol levels, C reactive protein and other routine laboratory parameters, and cortisol was also measured on the same day at 04:00 PM, and 12:00 AM. C reactive protein and other routine laboratory parameters were repeatedly measured at 08:00 AM on the following postoperative days, except for cortisol levels which were measured on postoperative days 3 and 5. Registered nurse carried out the standardized test (Delirium Observation Screening Scale (DOS) scale) to assess the patients for the development of postoperative delirium from second to fifth postoperative day (at 07:00 AM, 02:00 PM and 10:00 PM).
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Dexamethasone, Placebo
- Keywords
- Cognition Disorders, Cardiac Surgical Procedures, dexamethasone
- Medical subject headings
- Postoperative Cognitive Complications, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexasone
Intravenous dexamethasone (0.1 mg/kg) was administered 10 hours before surgery.
PlaceboOther
Also called Inactive substance
Normal saline (placebo) in the equal volume as active treatment was administered 10 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone dose of 0.1 mg/kg was administered intravenously 10h before surgery Receives: Drug: Dexamethasone |
| Control | Placebo comparator | Equal volume of normal saline (placebo) was administered intravenously 10h before surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests
Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at sixth postoperative day as determined by using a validated battery of cognitive tests that assess global cognitive function, psychomotor speed, visual-motor coordination, concentration, attention, short-term memory, learning curve and aspects of executive functioning. Time points of assessment are two days before surgery and six days after surgery in both study arms.
Measured: 9 days
Secondary outcomes (8)
Change in serum levels of S100β protein from baseline to first postoperative day
Serum levels of S100β protein were determined the day before surgery at 08:00 AM; 6 h and 30 h following the end of on-pump surgery; and 3 h following the end of off-pump surgery.
Measured: 3 days
Difference in S100β serum protein levels between control and intervention group on the day of surgery and first postoperative day
Measured: 7 days
Change in serum cortisol levels from baseline to fifth postoperative day
Cortisol levels were determined on the day before surgery at 08:00 AM; on the first postoperative day at 08:00 AM, 04:00 PM, and 12:00 AM; and at 08:00 AM on the third and fifth postoperative days.
Measured: 7 days
Difference in serum cortisol levels between control and intervention group on the first, third and fifth postoperative days
Measured: 7 days
Change in serum C reactive protein levels from baseline to fifth postoperative day
Baseline CRP levels were determined on the day before surgery at 08:00 AM, 1 h, 4 h and 12 h postoperatively; and at 08:00 AM from the first until fifth postoperative day.
Measured: 7 days
Difference in serum C reactive protein levels between control and intervention group on the day of surgery until the fifth postoperative day
Measured: 7 days
Difference in occurrence of systemic inflammatory response syndrome between control and intervention group within 48 h after surgery as determined by measuring body temperature, heart rate, respiratory rate, and white blood cell count.
Measured: 48 hours
Difference in occurrence of postoperative delirium between control and intervention group as determined from second until sixth postoperative day by using Delirium Observation Screening Scale
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center, Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Glumac, Clinical Hospital Center, Split
- Investigators
- Nenad Karanovic, MD, PhD, Study director, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767713
- Sponsor's protocol ID
- SPLIT1984
- Acronym
- CDCS
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.
PubMed 25225745Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
PubMed 11172175Roach 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 8948560Hudetz JA, Gandhi SD, Iqbal Z, Patterson KM, Pagel PS. Elevated postoperative inflammatory biomarkers are associated with short- and medium-term cognitive dysfunction after coronary artery surgery. J Anesth. 2011 Feb;25(1):1-9. doi: 10.1007/s00540-010-1042-y.
PubMed 21061037Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.
PubMed 16146456Mu DL, Li LH, Wang DX, Li N, Shan GJ, Li J, Yu QJ, Shi CX. High postoperative serum cortisol level is associated with increased risk of cognitive dysfunction early after coronary artery bypass graft surgery: a prospective cohort study. PLoS One. 2013 Oct 15;8(10):e77637. doi: 10.1371/journal.pone.0077637. eCollection 2013.
PubMed 24143249Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2.
PubMed 16738066Jensen BO, Hughes P, Rasmussen LS, Pedersen PU, Steinbruchel DA. Cognitive outcomes in elderly high-risk patients after off-pump versus conventional coronary artery bypass grafting: a randomized trial. Circulation. 2006 Jun 20;113(24):2790-5. doi: 10.1161/CIRCULATIONAHA.105.587931. Epub 2006 Jun 12.
PubMed 16769915Parolari A, Camera M, Alamanni F, Naliato M, Polvani GL, Agrifoglio M, Brambilla M, Biancardi C, Mussoni L, Biglioli P, Tremoli E. Systemic inflammation after on-pump and off-pump coronary bypass surgery: a one-month follow-up. Ann Thorac Surg. 2007 Sep;84(3):823-8. doi: 10.1016/j.athoracsur.2007.04.048.
PubMed 17720383Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.
PubMed 14616316Ernest CS, Worcester MU, Tatoulis J, Elliott PC, Murphy BM, Higgins RO, Le Grande MR, Goble AJ. Neurocognitive outcomes in off-pump versus on-pump bypass surgery: a randomized controlled trial. Ann Thorac Surg. 2006 Jun;81(6):2105-14. doi: 10.1016/j.athoracsur.2006.01.008.
PubMed 16731138Glumac S, Kardum G, Sodic L, Bulat C, Covic I, Carev M, Karanovic N. Longitudinal assessment of preoperative dexamethasone administration on cognitive function after cardiac surgery: a 4-year follow-up of a randomized controlled trial. BMC Anesthesiol. 2021 Apr 23;21(1):129. doi: 10.1186/s12871-021-01348-z.
PubMed 33892653Glumac S, Kardum G, Sodic L, Supe-Domic D, Karanovic N. Effects of dexamethasone on early cognitive decline after cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Nov;34(11):776-784. doi: 10.1097/EJA.0000000000000647.
PubMed 28985195
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammatory and Stress Response in the Pathogenesis of Cognitive Dysfunction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02767713
- Acronym / sponsor ID
- CDCS / SPLIT1984
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Cognition Disorders, Cardiac Surgical Procedures, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Clinical Hospital Center, SplitUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 May 2016 (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.
Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). The investigators focused on the role of inflammatory and stress response to surgical procedure as potential factors involved in the pathogenesis of cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated following cortisol levels and its daily variations. The degree of cognitive dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on the development of POCD was compared with control group that received normal saline.
Detailed description
This is a prospective, randomized, double blind, controlled trial. Following detailed past medical history assessment, two days before the surgical procedure neurocognitive function tests, depression and anxiety tests were carried out to assess the participants. Neurocognitive and anxiety tests were repeated on the 6th day after surgical procedure. A battery of tests lasting approximately 40 minutes were administered by a trained neuropsychologist from the Clinical Hospital Center, Split in a standardized fashion, at the same time of the day (10:00 AM) and in the same room at the Cardiac surgery ward. The investigators used a validated battery of tests which enabled the assessment of psychomotor speed, visual-motor coordination, concentration, attention, short-term memory and aspects of executive functioning. The evaluation was based on the following tests: Mini Mental State Examination (MMSE), Wechsler Memory Scale (WMS I \& II), Trail Making Test (TMT A \& B), Symbol Digit Modalities Test (SDMT), Controlled Oral Word Association Test (COWAT) and PsychE computer test. All of the tests except TMT A \& B have alternate forms. Croatian versions of Beck Depression Inventory-Second Edition (BDI II) and State-Trait Anxiety Inventory (STAI-M) were used for preoperative depression and trait and state anxiety assessment, respectively.
One day before the surgery (08:00 AM) blood samples were collected for determination of levels of S100β protein, cortisol and other routine laboratory parameters (white blood cell count (WBC), hematocrit, creatinine, glucose, albumin, sodium, potassium, C reactive protein (CRP), Troponin I hs).
Participants were randomized into two groups to receive either intravenous dexamethasone 0.1 mg/kg or the same volume of normal saline i.v. 10 hours before the surgery. Random sequence generator was used to determine participant allocation.
Anesthesia in all patients was based on fentanyl, midazolam, vecuronium and sevoflurane. The depth of anesthesia was monitored using bispectral index (BIS). During cardiopulmonary bypass alpha-stat technique was used with the maintenance of normothermia (35.5-36.5°C) or spontaneous hypothermia (up to 32°C). With the off-pump technique, the core temperature was maintained between 36 and 37°C. Surgical technique was standardized. Routine hemodynamic monitoring was performed throughout the surgery and continued on the first postoperative day. Plasma levels of S100β protein were determined 6 h and 30 h following the end of on-pump surgery, and 3 h following the end of off-pump surgery. C reactive protein levels and other routine laboratory parameters were measured from blood samples collected 1 h, 4 h and 12 h postoperatively. On the first postoperative day blood samples were collected at 08:00 AM to determine cortisol levels, C reactive protein and other routine laboratory parameters, and cortisol was also measured on the same day at 04:00 PM, and 12:00 AM. C reactive protein and other routine laboratory parameters were repeatedly measured at 08:00 AM on the following postoperative days, except for cortisol levels which were measured on postoperative days 3 and 5. Registered nurse carried out the standardized test (Delirium Observation Screening Scale (DOS) scale) to assess the patients for the development of postoperative delirium from second to fifth postoperative day (at 07:00 AM, 02:00 PM and 10:00 PM).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone dose of 0.1 mg/kg was administered intravenously 10h before surgery |
| Control | Placebo comparator | Other: PlaceboEqual volume of normal saline (placebo) was administered intravenously 10h before surgery |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants undergoing cardiac surgery: coronary artery bypass grafting, heart valve surgery or a combined procedure,
- Procedure must be elective
Key exclusion criteria (25 listed)
- Symptomatic cerebrovascular disease,
- Cerebrovascular incident in last 3 years,
- Neurodegenerative disease,
- Psychiatric disease,
- Visual, hearing or motor impairment interfering with cognitive testing,
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 |
|---|---|---|
| DexamethasoneAlso: DexasoneIntravenous dexamethasone (0.1 mg/kg) was administered 10 hours before surgery. | Drug | Dexamethasone |
| PlaceboAlso: Inactive substanceNormal saline (placebo) in the equal volume as active treatment was administered 10 hours before surgery. | Other | Control |
Primary outcome
Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests
Time frame: 9 days
Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at sixth postoperative day as determined by using a validated battery of cognitive tests that assess global cognitive function, psychomotor speed, visual-motor coordination, concentration, attention, short-term memory, learning curve and aspects of executive functioning. Time points of assessment are two days before surgery and six days after surgery in both study arms.
8 secondary outcomes
Change in serum levels of S100β protein from baseline to first postoperative day
Time frame: 3 days
Difference in S100β serum protein levels between control and intervention group on the day of surgery and first postoperative day
Time frame: 7 days
Change in serum cortisol levels from baseline to fifth postoperative day
Time frame: 7 days
Difference in serum cortisol levels between control and intervention group on the first, third and fifth postoperative days
Time frame: 7 days
Change in serum C reactive protein levels from baseline to fifth postoperative day
Time frame: 7 days
Difference in serum C reactive protein levels between control and intervention group on the day of surgery until the fifth postoperative day
Time frame: 7 days
Difference in occurrence of systemic inflammatory response syndrome between control and intervention group within 48 h after surgery as determined by measuring body temperature, heart rate, respiratory rate, and white blood cell count.
Time frame: 48 hours
Difference in occurrence of postoperative delirium between control and intervention group as determined from second until sixth postoperative day by using Delirium Observation Screening Scale
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Background: PubMed 25225745Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.
- Background: PubMed 11172175Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
- 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 21061037Hudetz JA, Gandhi SD, Iqbal Z, Patterson KM, Pagel PS. Elevated postoperative inflammatory biomarkers are associated with short- and medium-term cognitive dysfunction after coronary artery surgery. J Anesth. 2011 Feb;25(1):1-9. doi: 10.1007/s00540-010-1042-y.
- Background: PubMed 16146456Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.
- Background: PubMed 24143249Mu DL, Li LH, Wang DX, Li N, Shan GJ, Li J, Yu QJ, Shi CX. High postoperative serum cortisol level is associated with increased risk of cognitive dysfunction early after coronary artery bypass graft surgery: a prospective cohort study. PLoS One. 2013 Oct 15;8(10):e77637. doi: 10.1371/journal.pone.0077637. eCollection 2013.
- Background: PubMed 16738066Phillips-Bute B, Mathew JP, Blumenthal JA, Grocott HP, Laskowitz DT, Jones RH, Mark DB, Newman MF. Association of neurocognitive function and quality of life 1 year after coronary artery bypass graft (CABG) surgery. Psychosom Med. 2006 May-Jun;68(3):369-75. doi: 10.1097/01.psy.0000221272.77984.e2.
- Background: PubMed 16769915Jensen BO, Hughes P, Rasmussen LS, Pedersen PU, Steinbruchel DA. Cognitive outcomes in elderly high-risk patients after off-pump versus conventional coronary artery bypass grafting: a randomized trial. Circulation. 2006 Jun 20;113(24):2790-5. doi: 10.1161/CIRCULATIONAHA.105.587931. Epub 2006 Jun 12.
- Background: PubMed 17720383Parolari A, Camera M, Alamanni F, Naliato M, Polvani GL, Agrifoglio M, Brambilla M, Biancardi C, Mussoni L, Biglioli P, Tremoli E. Systemic inflammation after on-pump and off-pump coronary bypass surgery: a one-month follow-up. Ann Thorac Surg. 2007 Sep;84(3):823-8. doi: 10.1016/j.athoracsur.2007.04.048.
- Background: PubMed 14616316Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.
- Background: PubMed 16731138Ernest CS, Worcester MU, Tatoulis J, Elliott PC, Murphy BM, Higgins RO, Le Grande MR, Goble AJ. Neurocognitive outcomes in off-pump versus on-pump bypass surgery: a randomized controlled trial. Ann Thorac Surg. 2006 Jun;81(6):2105-14. doi: 10.1016/j.athoracsur.2006.01.008.
- Derived from this study: PubMed 33892653Glumac S, Kardum G, Sodic L, Bulat C, Covic I, Carev M, Karanovic N. Longitudinal assessment of preoperative dexamethasone administration on cognitive function after cardiac surgery: a 4-year follow-up of a randomized controlled trial. BMC Anesthesiol. 2021 Apr 23;21(1):129. doi: 10.1186/s12871-021-01348-z.
- Individual participant dataSharing planned: No
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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.
Nenad Karanovic, MD, PhD study director
Clinical Hospital Center, Split
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Postoperative Cognitive Dysfunction, run by Clinical Hospital Center, Split.
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 2 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
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?
Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (time frame: 9 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 NCT02767713, which also lists 13 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 10 May 2016; AzTrials last refreshed its copy on 26 Oct 2026.