Cardiac SurgeryNCT03624595
Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery
A study testing Dexmedetomidine in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Dong-Xin Wang at 2 sites in China.
Trial summary
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 2 sitesChina
- Study dates
- 16 Apr 2019to 18 May 2025
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years but <90 years;
- Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia;
- Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.
Who cannot join
- Patients who meet any of the following criteria will be excluded.
- Refuse to participate in the study;
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender [STOP-Bang] questionnaires ≥3);
- Inability to communicate during the preoperative period because of coma, profound dementia or language barrier;
- Preoperative sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker;
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- Severe hepatic dysfunction (Child-Pugh class C);
- Severe renal dysfunction (requirement of renal replacement therapy) before surgery;
- Presence of delirium (diagnosed by the Confusion Assessment Method [CAM]/CAM for the Intensive Care Unit [CAM-ICU]);
- Current treatment with dexmedetomidine or clonidine.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing University First Hospital
Beijing, Beijing Municipality, 100034
Fuwai Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
About this study
Official title: Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.
Read the detailed description
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes.
The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival.
The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine, Delirium, Survival
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine, Delirium, Survival
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Low-dose dexmedetomidine infusion
Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.
PlaceboDrug
Also called Normal saline infusion
Placebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1. Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | Placebo (normal saline) infusion is administered from 16:00 to 08:00 in the same speed for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium within the first 5 days after surgery
Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method (CAM, for patients without mechanical ventilation) or CAM for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5.
Measured: During the first 5 days after surgery
Secondary outcomes (7)
Duration of mechanical ventilation after surgery
Duration of mechanical ventilation after surgery
Measured: Up to 30 days after surgery
Length of stay in ICU after surgery
Length of stay in ICU after surgery
Measured: Up to 30 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery
Postoperative Major Adverse Cardiac Events (MACEs) include in-hospital death, myocardial infarction, second surgery, non-fetal cardiac arrest/ventricular fibrillation, and stroke. The occurrence of major postoperative events is followed up twice daily during postoperative days 1-5, then once a week until 30 days after surgery.
Measured: Up to 30 days after surgery
Incidence of other complications
Incidence of other complications (including hospital re-admission) within 30 days after surgery.
Measured: Up to 30 days after surgery
All-cause 30-day mortality
All-cause mortality within 30 days after surgery
Measured: At 30 days after surgery
Subjective sleep quality at 30 days after surgery
Subjective sleep quality at 30 days after surgery is assessed with Pittsburgh sleep quality index (PSQI)
Measured: At 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start16 Apr 2019
- Primary completion3 Jul 2021
- Study completion18 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-Xin Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Responsible party
- Sponsor-investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624595
- Sponsor's protocol ID
- 2018-181
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crocker E, Beggs T, Hassan A, Denault A, Lamarche Y, Bagshaw S, Elmi-Sarabi M, Hiebert B, Macdonald K, Giles-Smith L, Tangri N, Arora RC. Long-Term Effects of Postoperative Delirium in Patients Undergoing Cardiac Operation: A Systematic Review. Ann Thorac Surg. 2016 Oct;102(4):1391-9. doi: 10.1016/j.athoracsur.2016.04.071. Epub 2016 Jun 22.
PubMed 27344279Gosselt AN, Slooter AJ, Boere PR, Zaal IJ. Risk factors for delirium after on-pump cardiac surgery: a systematic review. Crit Care. 2015 Sep 23;19(1):346. doi: 10.1186/s13054-015-1060-0.
PubMed 26395253Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Mu 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 24143249Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
PubMed 25230376Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
PubMed 24476433Delaney LJ, Van Haren F, Lopez V. Sleeping on a problem: the impact of sleep disturbance on intensive care patients - a clinical review. Ann Intensive Care. 2015 Feb 26;5:3. doi: 10.1186/s13613-015-0043-2. eCollection 2015.
PubMed 25852963Korompeli A, Muurlink O, Kavrochorianou N, Katsoulas T, Fildissis G, Baltopoulos G. Circadian disruption of ICU patients: A review of pathways, expression, and interventions. J Crit Care. 2017 Apr;38:269-277. doi: 10.1016/j.jcrc.2016.12.006. Epub 2016 Dec 13.
PubMed 28012425Fanfulla F, Ceriana P, D'Artavilla Lupo N, Trentin R, Frigerio F, Nava S. Sleep disturbances in patients admitted to a step-down unit after ICU discharge: the role of mechanical ventilation. Sleep. 2011 Mar 1;34(3):355-62. doi: 10.1093/sleep/34.3.355.
PubMed 21358853Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
PubMed 23506782McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
PubMed 23263581Leung JM, Sands LP, Newman S, Meckler G, Xie Y, Gay C, Lee K. Preoperative Sleep Disruption and Postoperative Delirium. J Clin Sleep Med. 2015 Aug 15;11(8):907-13. doi: 10.5664/jcsm.4944.
PubMed 25979094Roggenbach J, Klamann M, von Haken R, Bruckner T, Karck M, Hofer S. Sleep-disordered breathing is a risk factor for delirium after cardiac surgery: a prospective cohort study. Crit Care. 2014 Sep 5;18(5):477. doi: 10.1186/s13054-014-0477-1.
PubMed 25189637Papaioannou V, Mebazaa A, Plaud B, Legrand M. 'Chronomics' in ICU: circadian aspects of immune response and therapeutic perspectives in the critically ill. Intensive Care Med Exp. 2014 Dec;2(1):18. doi: 10.1186/2197-425X-2-18. Epub 2014 May 14.
PubMed 26266918Alamili M, Bendtzen K, Lykkesfeldt J, Rosenberg J, Gogenur I. Melatonin suppresses markers of inflammation and oxidative damage in a human daytime endotoxemia model. J Crit Care. 2014 Feb;29(1):184.e9-184.e13. doi: 10.1016/j.jcrc.2013.09.006. Epub 2013 Oct 17.
PubMed 24140166
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03624595
- Acronym / sponsor ID
- 2018-181
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine, Delirium, Survival
- Keywords
- Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine, Delirium, Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Dong-Xin WangUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 18 May 2025 (actual)
- First posted
- 10 Aug 2018 (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.
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.
Detailed description
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes.
The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival.
The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineDexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo (normal saline) infusion is administered from 16:00 to 08:00 in the same speed for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥60 years but <90 years;
- Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia;
- Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.
Key exclusion criteria (10 listed)
- Patients who meet any of the following criteria will be excluded.
- Refuse to participate in the study;
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender [STOP-Bang] questionnaires ≥3);
- Inability to communicate during the preoperative period because of coma, profound dementia or language barrier;
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 |
|---|---|---|
| DexmedetomidineAlso: Low-dose dexmedetomidine infusionDexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1. | Drug | Dexmedetomidine group |
| PlaceboAlso: Normal saline infusionPlacebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1. | Drug | Placebo group |
Primary outcome
Incidence of delirium within the first 5 days after surgery
Time frame: During the first 5 days after surgery
Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method (CAM, for patients without mechanical ventilation) or CAM for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5.
7 secondary outcomes
Duration of mechanical ventilation after surgery
Time frame: Up to 30 days after surgery
Length of stay in ICU after surgery
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery
Time frame: Up to 30 days after surgery
Incidence of other complications
Time frame: Up to 30 days after surgery
All-cause 30-day mortality
Time frame: At 30 days after surgery
Subjective sleep quality at 30 days after surgery
Time frame: At 30 days 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 27 Apr 2026.
- Background: PubMed 27344279Crocker E, Beggs T, Hassan A, Denault A, Lamarche Y, Bagshaw S, Elmi-Sarabi M, Hiebert B, Macdonald K, Giles-Smith L, Tangri N, Arora RC. Long-Term Effects of Postoperative Delirium in Patients Undergoing Cardiac Operation: A Systematic Review. Ann Thorac Surg. 2016 Oct;102(4):1391-9. doi: 10.1016/j.athoracsur.2016.04.071. Epub 2016 Jun 22.
- Background: PubMed 26395253Gosselt AN, Slooter AJ, Boere PR, Zaal IJ. Risk factors for delirium after on-pump cardiac surgery: a systematic review. Crit Care. 2015 Sep 23;19(1):346. doi: 10.1186/s13054-015-1060-0.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- 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 25230376Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
- Background: PubMed 24476433Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
- Background: PubMed 25852963Delaney LJ, Van Haren F, Lopez V. Sleeping on a problem: the impact of sleep disturbance on intensive care patients - a clinical review. Ann Intensive Care. 2015 Feb 26;5:3. doi: 10.1186/s13613-015-0043-2. eCollection 2015.
- Background: PubMed 28012425Korompeli A, Muurlink O, Kavrochorianou N, Katsoulas T, Fildissis G, Baltopoulos G. Circadian disruption of ICU patients: A review of pathways, expression, and interventions. J Crit Care. 2017 Apr;38:269-277. doi: 10.1016/j.jcrc.2016.12.006. Epub 2016 Dec 13.
- Background: PubMed 21358853Fanfulla F, Ceriana P, D'Artavilla Lupo N, Trentin R, Frigerio F, Nava S. Sleep disturbances in patients admitted to a step-down unit after ICU discharge: the role of mechanical ventilation. Sleep. 2011 Mar 1;34(3):355-62. doi: 10.1093/sleep/34.3.355.
- Background: PubMed 23506782Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
- Background: PubMed 23263581McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b.
- Background: PubMed 25979094Leung JM, Sands LP, Newman S, Meckler G, Xie Y, Gay C, Lee K. Preoperative Sleep Disruption and Postoperative Delirium. J Clin Sleep Med. 2015 Aug 15;11(8):907-13. doi: 10.5664/jcsm.4944.
- 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.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Dong-Xin Wang at 2 sites in China.
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 10 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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.
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?
Incidence of delirium within the first 5 days after surgery (time frame: During the first 5 days after surgery). 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 NCT03624595, which also lists 35 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 27 Apr 2026.