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NCT Number: NCT03636074

Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): 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.

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Key information

Conditions

Cognitive Dysfunction Body Temperature Changes Cognition Disorders Confusion Delirium Emergence Delirium Hypothermia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli Studi di Padova

Padova, PD, 35128, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermia during Extracorporeal Circulation

Procedure

Normothermia during Extracorporeal Circulation

Primary outcomes

  1. Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

    Time frame: 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.

  2. Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

    Time frame: 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 Delayed Neurocognitive Recovery in Cardiac-Surgery

    Time frame: 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 Delayed Neurocognitive Recovery in Cardiac-Surgery

    Time frame: 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 outcomes

  1. Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: DNR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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