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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively. |
|
| Placebo | Placebo Comparator | normal saline administration matching dexmedetomidine rate of infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Atrial Arrhythmia | The occurrence of postoperative atrial arrhythmias | From the end of surgery to postoperative day 5 |
| Number of Patients With Delirium | The occurrence of postoperative delirium | From the end of surgery to postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Acute Kidney Injury | Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function. | From the end of surgery to postoperative day 5 |
| Number of Patients With Incisional Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, MD | Staff member | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32682483 | Derived | Turan A, Duncan A, Leung S, Karimi N, Fang J, Mao G, Hargrave J, Gillinov M, Trombetta C, Ayad S, Hassan M, Feider A, Howard-Quijano K, Ruetzler K, Sessler DI; DECADE Study Group. Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial. Lancet. 2020 Jul 18;396(10245):177-185. doi: 10.1016/S0140-6736(20)30631-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively. Dexmedetomidine: Dexmedetomidine |
| FG001 | Placebo | normal saline administration matching dexmedetomidine rate of infusion. Placebo: Normal saline administration matching dexmedetomidine rate of infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively. Dexmedetomidine: Dexmedetomidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only reported the mean and standard deviation for each group. Age is not available for 4 patients. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Atrial Arrhythmia | The occurrence of postoperative atrial arrhythmias | 2 patients had no Atrial Arrhythmia data. | Posted | Count of Participants | Participants | From the end of surgery to postoperative day 5 |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively. Dexmedetomidine: Dexmedetomidine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically important bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alparslan Turan | Cleveland Clinic Foundation | 216-445-9857 | turana@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2016 | Sep 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Normal saline administration matching dexmedetomidine rate of infusion |
|
|
Patients were evaluated at 90 days by modified Brief Pain Inventory. |
| 90 days after surgery |
| BG001 | Placebo | normal saline administration matching dexmedetomidine rate of infusion. Placebo: Normal saline administration matching dexmedetomidine rate of infusion |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 4 patients sex data were not availiable. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 5 patients didn't had availiable race data. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Modified Brief Pain Inventory | 44 patients' baseline MBPI information was not available. Any overall severity means any pain in the last 24 hours. Any pain inference means any pain that interfering with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life in the last 24 hours. | Count of Participants | Participants |
|
| Placebo |
normal saline administration matching dexmedetomidine rate of infusion. Placebo: Normal saline administration matching dexmedetomidine rate of infusion |
|
|
|
| Primary | Number of Patients With Delirium | The occurrence of postoperative delirium | Delirium data is not available in 18 patients. | Posted | Count of Participants | Participants | From the end of surgery to postoperative day 5 |
|
|
|
|
| Secondary | Number of Patients With Acute Kidney Injury | Acute kidney injury is defined according to Acute Kidney Injury Network (AKIN) classifications. No risk means no risk of acute kidney injury, while a higher stage means worse kidney function. | Acute kidney injury data is not available in 16 patients. | Posted | Count of Participants | Participants | From the end of surgery to postoperative day 5 |
|
|
|
|
| Secondary | Number of Patients With Incisional Pain | Patients were evaluated at 90 days by modified Brief Pain Inventory. | Incisional pain at 90 days is not available in 205 patients. | Posted | Count of Participants | Participants | 90 days after surgery |
|
|
|
|
| 1 |
| 394 |
| 21 |
| 394 |
| 234 |
| 394 |
| EG001 | Placebo | normal saline administration matching dexmedetomidine rate of infusion. Placebo: Normal saline administration matching dexmedetomidine rate of infusion | 1 | 390 | 8 | 390 | 154 | 390 |
| asystol | Cardiac disorders | Non-systematic Assessment |
|
| heart failure | Cardiac disorders | Non-systematic Assessment |
|
| re-intervention | Cardiac disorders | Non-systematic Assessment | The patient went back to the operation room for redo complex mitral valve repair with plication |
|
| infection | Infections and infestations | Non-systematic Assessment |
|
| seizure | Nervous system disorders | Non-systematic Assessment |
|
| stroke | Nervous system disorders | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypotension | Vascular disorders | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Elevated troponin postoperatively |
|
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
|
| Transient Ischemic attack | Nervous system disorders | Non-systematic Assessment |
|
| Clinically important hypotension | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Stage2 |
|
| Stage3 |
|