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Cognitive Dysfunction Following Cardiac Surgery

NCT02767713 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2016-05-10

No results posted yet for this study

Summary

Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). The investigators focused on the role of inflammatory and stress response to surgical procedure as potential factors involved in the pathogenesis of cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated following cortisol levels and its daily variations. The degree of cognitive dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on the development of POCD was compared with control group that received normal saline.

Conditions

  • Postoperative Cognitive Dysfunction

Interventions

DRUG

Dexamethasone

Intravenous dexamethasone (0.1 mg/kg) was administered 10 hours before surgery.

OTHER

Placebo

Normal saline (placebo) in the equal volume as active treatment was administered 10 hours before surgery.

Sponsors & Collaborators

  • Clinical Hospital Center, Split

    lead OTHER

Principal Investigators

  • Nenad Karanovic, MD, PhD · Clinical Hospital Center, Split

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-01-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02767713 on ClinicalTrials.gov