NCT03636074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

August 7, 2018

Last Update Submit

November 6, 2023

Conditions

Cognitive DysfunctionEmergence DeliriumHypothermia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (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

Study Arms (2)

Hearth-valve surgery

Procedure: Hypothermia during Extracorporeal Circulation

Hearth bypass surgery

Procedure: Hypothermia during Extracorporeal Circulation

Interventions

Hypothermia during Extracorporeal CirculationPROCEDURE

Normothermia during Extracorporeal Circulation

Hearth bypass surgeryHearth-valve surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective Observational Case-Control

You may qualify if:

  • Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Padova

Padua, PD, 35128, Italy

Location

MeSH Terms

Conditions

Cognitive DysfunctionEmergence DeliriumHypothermia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBody Temperature Changes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 17, 2018

Study Start

January 7, 2020

Primary Completion

May 30, 2023

Study Completion

June 12, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

IT(1)