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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Emergence Delirium; Hypothermia
• Intervention / Treatment: Procedure: Hypothermia during Extracorporeal Circulation

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

• Study Contact: Name: Federico Linassi, MD; Phone Number: 049 8213090; Email: federico.linassi@studenti.unipd.it

Study Locations

• Italy
  • PD
    • Padova, PD, Italy, 35128
      • Universita degli Studi di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Prospective Observational Case-Control

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Body Temperature Changes; Delirium; Cognitive Dysfunction; Emergence Delirium; Hypothermia
• Other Study ID Numbers: Zivago

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No