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Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery (ICARUS)

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Near-Infrared Spectroscopy (NIRS)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Delirium focused on measuring Aortic valve replacement with or without CABG

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study group

Arm Description

Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without 'Coronary Artery Bypass Graft' (CABG) surgery)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2015
Last Updated
March 24, 2018
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT02532530
Brief Title
Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery
Acronym
ICARUS
Official Title
Peri-operative Monitoring of Regional Cerebral Oxygen Saturation and Onset of Delirium in Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Aortic valve replacement with or without CABG

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Other
Arm Description
Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without 'Coronary Artery Bypass Graft' (CABG) surgery)
Intervention Type
Device
Intervention Name(s)
Near-Infrared Spectroscopy (NIRS)
Intervention Description
Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation.
Primary Outcome Measure Information:
Title
Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)
Description
The primary objective is to investigate if the development of delirium after cardiac surgery coincides with changes of the cerebral oxygen saturation.
Time Frame
pre, intra and postoperative measurement of cerebral oxygen saturation (three days)
Secondary Outcome Measure Information:
Title
Cerebral autoregulation performance using a COX index
Description
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.
Time Frame
Intraoperative measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Jans, prof. dr.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
31862160
Citation
Eertmans W, De Deyne C, Genbrugge C, Marcus B, Bouneb S, Beran M, Fret T, Gutermann H, Boer W, Vander Laenen M, Heylen R, Mesotten D, Vanelderen P, Jans F. Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery. Br J Anaesth. 2020 Feb;124(2):146-153. doi: 10.1016/j.bja.2019.09.042. Epub 2019 Dec 18.
Results Reference
derived

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Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery

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