Effects of Hypothermia on Post-Operative Cognitive Dysfunction: an Observational Trial Among Patients Undergoing Cardiac-Surgery

• Sponsor: University of Padova (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03636074
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 33.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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 Post-operative cognitive dysfunction. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Dysfunction; Emergence Delirium; Hypothermia	Procedure: Hypothermia during Extracorporeal Circulation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effects of Hypothermia on Post-Operative Cognitive Dysfunction: an Observational Trial Among Patients Undergoing Cardiac-Surgery
• Actual Study Start Date: Jan 7, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Hearth-valve surgery	Procedure: Hypothermia during Extracorporeal Circulation; Normothermia during Extracorporeal Circulation
Hearth bypass surgery	Procedure: Hypothermia during Extracorporeal Circulation; Normothermia during Extracorporeal Circulation

Outcome Measures

Primary Outcome Measures

1. Incidence of Post-Operative Cognitive dysfunction in Cardiac-Surgery [Patients will be subjected to Montreal Cognitive Assessment test one day before surgery and 4-6 days after surgery]

   Discover changes between pre-operative Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score.

2. Incidence of Post-Operative Cognitive dysfunction in Cardiac-Surgery [Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery]

   Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score.

3. Incidence of Post-Operative Cognitive dysfunction in Cardiac-Surgery [Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery]

   Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score.

4. Incidence of Post-Operative Cognitive dysfunction in Cardiac-Surgery [Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery]

   Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and

Secondary Outcome Measures

1. Effects of 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]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Università degli Studi di Padova	Padova	PD	Italy	35128

Sponsors and Collaborators

• University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Federico Linassi, MD, Principal Investigator, University of Padova
• ClinicalTrials.gov Identifier: NCT03636074
• Other Study ID Numbers: Zivago
• First Posted: Aug 17, 2018
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium; Emergence Delirium; Hypothermia; Postoperative Cognitive Complications; Cognitive Dysfunction

Study Results

No Results Posted as of Mar 11, 2022