Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries (CSINVOS)

This study has been completed.
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01412619
First received: August 2, 2011
Last updated: December 24, 2011
Last verified: December 2011
  Purpose

Patients after cardiac surgical operations often exhibit neuropsychological complications. In particular, the post-operative delirium is associated with a significantly increased morbidity and mortality.

Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery was verified as the main cause of this.

The aim of the study is to demonstrate a correlation between intraoperative low measured cerebral oxygen levels and a loss neurological outcome, especially the development of postoperative delirium, using non-invasive cerebral oximetry (RSO2).


Condition
Neurological Outcome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CSINVOS: Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire [ Time Frame: Changes between 6 - 48 hours before surgery and 12 hours after surgery ] [ Designated as safety issue: No ]
    CAM-ICU Quesionnaire is used to assess the patient´s ability of postoperative orientation, to detect and treat changes between preoperative and postoperative questionnaires and therefore a potential postoperative delirium earliest possible.


Secondary Outcome Measures:
  • MIF (Macrophage Migration Inhibitory Factor) [ Time Frame: Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests. ] [ Designated as safety issue: No ]
    MIF is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.

  • Cytokine IL-6 [ Time Frame: Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests. ] [ Designated as safety issue: No ]
    Cytokine IL-6 is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.

  • Cytokine IL-10 [ Time Frame: Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests. ] [ Designated as safety issue: No ]
    Cytokine IL-10 is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.

  • Procalcitonin (PCT) [ Time Frame: Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests. ] [ Designated as safety issue: No ]
    PCT is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.

  • S-100 Protein [ Time Frame: Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests. ] [ Designated as safety issue: No ]
    S-100 Protein is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.

  • SOFA-Score (Sequential Organ Failure Assessment score) [ Time Frame: 12 hours after surgery ] [ Designated as safety issue: No ]
    The SOFA score is used to track a patient's status during the stay in the ICU


Biospecimen Retention:   Samples Without DNA

Cytokine IL-6 Cytokine IL-10 Procalcitonin (PCT) S-100-Protein


Estimated Enrollment: 50
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Before the operation, the parameters required for the collection of the EURO-scores are recorded, allowing an assessment of perioperative risk (age, gender, type of planned surgery, concomitant diseases).

After the patient arrives in the operating room the required electrodes to measure the intracerebral oxygenation are stuck bitemporal on the patient´s head. The measurement of oxygenation begins before induction of anaesthesia (while the patient is still awake) and will continue until 24 h postoperatively.

The measurement of cerebral oxygenation is not intended to serve as a replacement for the collection of routine peripheral oxygen saturation, but will be performed additionally.Therefore the anaesthesiological management depends primarily on the peripheral oxygen saturation and arterial blood gases according to our clinical routine.

If, however, intracerebral oxygenation shows an ominous decline, this change can be corrected by targeted measures very early (such as increasing the inspiratory oxygen concentration). At the specified test points following additional parameters are determined: Mean arterial blood pressure, central venous blood pressure, cardiac output, serum lactate, venous oxygen saturation, arterial blood gas analysis, fluid balance. These parameters are collected as part of a routine cardiac surgery. To measure these parameters no additional punctuation or blood draws are therefore necessary. To determine the cytokines IL-6 and IL-10, procalcitonin (PCT) and the S-100 protein, however, it is necessary to take 5ml blood to the respective measuring points from an already existing venous access.

In the ICU the collection of the above mentioned parameters occurs at admission, after 6h and 12h, and on the morning of the first postoperative day (and possibly on further ICU-treatment-days). Additionally, each 12 h after surgery, the SOFA and the CAM-ICU-Score are recorded.

An already before surgery performed CAM-ICU questionnaire serves as a direct comparison with the post-operative acquired CAM-ICU score. In case the patient is still be ventilated, the test cannot be performed and will be documented correspondingly.

The treatment, monitoring of vital signs including intermittent blood gas analysis and other diagnostic measures (clinical chemistry, radiology, etc.) corresponds to the standard surgical procedure for heart surgery of the University Hospital Aachen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 100 adult patients (male and female), capable of consenting, undergoing elective cardiac surgery at heart-lung-machine

Criteria

Inclusion Criteria:

  • Age of 18 years or older
  • Elective cardiac surgery at heart-lung-machine

Exclusion Criteria:

  • Pregnancy or lactation period
  • Patients not capable of consenting
  • Emergency surgery
  • Patients under 18 years
  • Known depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412619

Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PI: PD Dr. med. Steffen Rex, Clinic for Anaesthesiology, Clinical Trial Center Aachen
ClinicalTrials.gov Identifier: NCT01412619     History of Changes
Other Study ID Numbers: CTC-A 11-131 CSINVOS
Study First Received: August 2, 2011
Last Updated: December 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Neurological Outcome
Intraoperative intracerebral Oxygen level
Mean arterial blood pressure
Central venous blood pressure
Cardiac output
Serum Lactate
Venous oxygen saturation
Fluid balance

ClinicalTrials.gov processed this record on August 28, 2014