Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery

Cognitive Impairment Clinical Trial

Official title:

The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088100
• Other study ID #: MVH-01
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: January 7, 2011
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5 genotype carries a higher risk of post-operative cognitive dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia

Exclusion Criteria:

• daily use of major tranquilizers or antipsychotic medication

• known disease of the CNS

• score less than 24/30 points in MMSE

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Genotype

Intervention

Genetic:
• Genotyping
Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples

Locations

Country	Name	City	State
Denmark	Herlev Hospital - Gastro unit	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Abildstrom H, Christiansen M, Siersma VD, Rasmussen LS; ISPOCD2 Investigators. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology. 2004 Oct;101(4):855-61. — View Citation

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. Erratum in: Lancet 1998 Jun 6;351(9117):1742. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPER3 genotype		3 months	No
Secondary	Post-operative morbidity		½ year	No