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Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries (CSINVOS)
This study has been completed.
Study NCT01412619   Information provided by RWTH Aachen University

First Received on August 2, 2011.   Last Updated on December 24, 2011   History of Changes

August 2, 2011
December 24, 2011
December 2008
December 2011   (final data collection date for primary outcome measure)
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.
CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire [ Time Frame: Between 6 hours and 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 a potential postoperative delirium earliest possible
Complete list of historical versions of study NCT01412619 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries
CSINVOS: Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries

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).

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.

Observational
Time Perspective: Prospective
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

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

Neurological Outcome
 
 
Stoppe C, Fries M, Rossaint R, Grieb G, Coburn M, Simons D, Brücken D, Bernhagen J, Pallua N, Rex S. Blood levels of macrophage migration inhibitory factor after successful resuscitation from cardiac arrest. PLoS One. 2012;7(4):e33512. Epub 2012 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01412619
CTC-A 11-131 CSINVOS
No
PI: PD Dr. med. Steffen Rex, Clinic for Anaesthesiology, Clinical Trial Center Aachen
RWTH Aachen University
 
 
RWTH Aachen University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP