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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03636074

Acronym

DNR

Enrollment

168

Registered

2018-08-17

Start date

2020-01-07

Completion date

2023-06-12

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Emergence Delirium, Hypothermia

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

Interventions

PROCEDUREHypothermia during Extracorporeal Circulation

Normothermia during Extracorporeal Circulation

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	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	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.

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026