Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery

Cognitive Dysfunction Clinical Trial

— DNR  

Official title:

Effects of Hypothermia on Delayed Neurocognitive Recovery: an Observational Trial Among Patients Undergoing Cardiac-Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636074
• Other study ID #: Zivago
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: June 12, 2023

Study information

• Verified date: November 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 12, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria:

• Neurological disease before surgery
• Sedation in Cardiac-Surgery Intensive Unit > 6 hours
• Cerebral regional Oxygen saturation <20% baseline during surgery

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Emergence Delirium
• Hypothermia

Intervention

Procedure:
• Hypothermia during Extracorporeal Circulation
Normothermia during Extracorporeal Circulation

Locations

Country	Name	City	State
Italy	Università degli Studi di Padova	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	Discover changes between pre-operative general cognition tests (Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire) test score and post-operative Montreal Cognitive Assessment test score.	Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery
Primary	Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score.	Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery
Primary	Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score.	Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery
Primary	Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and	Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery
Secondary	Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery	Discover statistical significance difference in incidence of Post-Operative Cognitive Decline between patients undergoing normothermia and patients undergoing hypothermia during Extracorporeal Circulation in Cardiac Surgery	One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline