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Low Dose Dexmedetomidine and Delirium After Cardiac Surgery (LOWDEXDEL)

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ClinicalTrials.gov Identifier: NCT03388541
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:

Delirium after cardiac surgery can occur in up to 50% of the patients and has been shown to be significantly associated with increased morbidity and mortality. Advanced age is a significant risk factor of delirium.

Numerous studies have shown that sedation with high doses of Dexmedetomidine in the ICU reduces the incidence of postoperative delirium. On the other hand animal studies have shown neuroprotective effects of Dexmedetomidine by means of stimulating alpha2A-adrenoceptors.

It is not clear whether the administration of a low dose Dexmedetomidine in cardiac surgery would have any neuroprotective effects by stimulating the alpha 2A-receptors and as such would decrease the incidence of postoperative delirium.


Condition or disease Intervention/treatment Phase
Cardiac Surgical Procedures Drug: Dexmedetomidine Drug: Placebo Phase 4

Detailed Description:

Postoperative delirium (PD) is a common problem in cardiac surgical patients. Its incidence varies among studies and can reach up to 50% of the patients. PD is associated with increased morbidity and mortality. Its occurrence is the resultant between the predisposing factors and the precipitating factors. Age seems to be a significant predisposing factor. In this regard the pathophysiology of PD is not yet fully understood. There are several hypothetical mechanisms for the development of PD. The first hypothesis is cerebral ischemia and BBB breakdown. The second hypothesis is neuro-inflammation. Peripheral pro-inflammatory mediators especially released during surgery would interact with the brain. Otherwise there is the problem of sleep deprivation/fragmentation in patients admitted to the hospital.

Dexmedetomidine is a potent and more selective alpha2-adrenergic receptor than clonidine. Studies have demonstrated that it has neuroprotective and anti-inflammatory actions.

Numerous studies including trials in cardiac surgery have shown a decreased incidence of delirium when Dexmedetomidine was used as sedative in the ICU compared with other sedatives acting on the GABA receptors. However, in these studies high doses of Dexmedetomidine were used for periods up to 24h. Dexmedetomidine was started in the ICU and was not compared in a double-blind fashion with placebo. In a recent randomized double-blind placebo-controlled trial a very low dose of Dexmedetomidine decreased the occurrence of PD when compared to placebo. However this study was performed in non-cardiac patients. Moreover the patients were included after their arrival in the ICU, which means that those patients who were intubated at their arrival in the ICU were not included. And again the study medication was only started after arrival in the ICU.

The aim of this study is to elucidate whether the administration of Dexmedetomidine at a low dose would decrease the incidence of PD in elderly patients undergoing cardiac surgery. The hypothesis is that Dexmedetomidine at low doses, by only stimulating the alpha2A adrenoceptors,would have neuroprotective affects ans as such decrease the incidence of PD. Dexmedetomidine would also have anti-inflammatory effects and effects on the quality of sleep. Both mechanisms would play a role in the pathophysiology of PD.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does LOW Dose DEXmedetomidine After Cardiopulmonary Bypass Separation Decrease the Incidence of DELirium: A Double-blind Randomized Placebo-controlled Study (LOWDEXDEL Study)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dexmedetomidine
Dexmedetomidine will be administered at 0.4ug/kg/h (5mL/h) starting at the closure of the chest and continued during 10h.
Drug: Dexmedetomidine
Dexmedetomidine will be started at 5mL/h while the patient is still in the operating room.
Placebo Comparator: Placebo
NaCl 0.9% will be administered at 5mL/h starting at the closure of the chest and continued during 10h.
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. The incidence of delirium [ Time Frame: Through study completion, an average of 30 days ]
    The incidence of delirium detected by means of CAM-ICU and CAM


Secondary Outcome Measures :
  1. Number of days spent in delirium [ Time Frame: Through study completion, an average of 30 days ]
    Total number of days in a delirious state

  2. ICU stay [ Time Frame: Through study completion, an average of 30 days ]
    The duration of days admitted in the ICU and in the hospital

  3. Total dose of analgesics [ Time Frame: Through study completion, an average of 30 days ]
    Total dose of analgesics used in the ICU

  4. Total dose of vasopressors [ Time Frame: Through study completion, an average of 30 days ]
    Total dose of vasopressors used in the ICU

  5. Pace maker necessitation [ Time Frame: Through study completion, an average of 30 days ]
    Number of patients needing external pacing

  6. costs [ Time Frame: Through study completion, an average of 30 days ]
    Estimated total cost of hospital stay per day

  7. Hospital stay [ Time Frame: Through study completion, an average of 30 days ]
    The duration of days admitted in the hospital

  8. Total dose sedatives [ Time Frame: Through study completion, an average of 30 days ]
    Total dose of sedatives used in the ICU

  9. Total dose of inotropic agents [ Time Frame: Through study completion, an average of 30 days ]
    Total dose of inotropic agents used in the ICU



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Hepatic dysfunction (hepatic function tests 3 times the normal value)
  • Preoperative renal replacement therapy
  • Preoperative delirium
  • Emergency surgery not allowing neurologic evaluation by MMSE
  • Mini invasive cardiac surgery
  • Patients not speaking French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388541


Contacts
Contact: Mona MOMENI, MD,PhD 00322747029 mona.momeni@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium, 1200
Principal Investigator: MONA MOMENI, M.D.; PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Mona Momeni, MD,PhD Cliniques universitaires Saint-Luc

Publications:

Responsible Party: Mona Momeni, MD, PhD, Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03388541     History of Changes
Other Study ID Numbers: 2017/24JUL/374
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action