Delirium Clinical Trial
— ICARUSOfficial title:
Peri-operative Monitoring of Regional Cerebral Oxygen Saturation and Onset of Delirium in Cardiac Surgery Patients
Verified date | March 2018 |
Source | Hasselt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Delirium is an acute brain syndrome characterized by a disturbance in consciousness
accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant
speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have
been associated with a prolonged hospital stay, functional and cognitive dysfunction and even
an increased mortality. Delirium is a common complication in the postoperative setting where
the incidence increases with the risk of surgery. The estimated incidence of postoperative
delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse
preoperative risk factors have been documented for patients undergoing cardiac surgery: age,
pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at
admission.
An early diagnosis of postoperative delirium is of great importance to prevent long-term
cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should
be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS)
provides information on brain oxygenation by quantifying the regional cerebral oxygen
saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative
cerebral tissue oxygenation was lower in the cohort of patients that developed delirium
postoperatively. Nevertheless, these studies did not investigate whether the onset of
postoperative delirium coincided with a change of postoperative SctO2. A relationship between
delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence
of a postoperative decrease of SctO2 might have been overlooked thus far. Hence,
Investigators want to conduct a prospective, interventional study to determine the
relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.
Status | Completed |
Enrollment | 103 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (age = 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without Coronary artery bypass graft surgery (CABG)) - Surgery has to be performed under normothermic conditions - Ability to perform the confusion assessment method for the intensive care unit (CAM-ICU) - Patients willing to provide written informed consent Exclusion Criteria: - Age < 70 years - Off-pump cardiac surgery - Surgery performed under hypothermic conditions - Duration before extubation > 36 hours - Patients with insufficient knowledge of the Dutch language - Patients using antipsychotics - Patients with a known history of alcohol abuse (consuming two or more units a day) |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk |
Lead Sponsor | Collaborator |
---|---|
Hasselt University | Ziekenhuis Oost-Limburg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative) | The primary objective is to investigate if the development of delirium after cardiac surgery coincides with changes of the cerebral oxygen saturation. | pre, intra and postoperative measurement of cerebral oxygen saturation (three days) | |
Secondary | Cerebral autoregulation performance using a COX index | Comparison of the cerebral autoregulation using a COX index (correlation between Mean arterial pressure and SctO2) in patients with and without a stage of delirium. | Intraoperative measurement |
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