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Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT02979275
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Romuald Lango, Medical University of Gdansk

Brief Summary:
Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood samples during the first post-op day.

Condition or disease Intervention/treatment
Acute Kidney Injury Heart Valve Diseases Procedure: Open heart surgery on cardiopulmonary bypass.

Detailed Description:

The day before operation, after verification of inclusion and exclusion criteria, the visiting anesthesiologist will explain to the patient the aim of the study. By signing an informed consent the patient will be recruited into the study. On the evening before operation the patient will receive the statin in a dose taken along.

In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured the day before operation - if not, a blood sample for the test will be obtained and sent to perform the tests.

Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic Oximeter, Somanetics, Medtronic) will be placed.

Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will be recorded before and during operation on nine timepoints.

As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative monitoring, patient had to sign an informed consent to participate into the study, and ethic committee approval for the study protocol was appealed and granted.

General anesthesia will be induced by: fentanyl 0.2 mg, propofol 0.5-1.5 mg/kg in bolus 200ml/godz.; and rocuronium - 0.5 mg/kg. After induction dexamethasone will be given in a dose of 0,7-1 mg/kg. For conduction of anesthesia before cardiopulmonary bypass (CPB) sevoflurane will be added to the inhaled mixture of air and oxygen. On CPB propofol will be given iv. In case of hemodynamic instability after commencing CPB, which will require catecholamines in a cumulative dose of > 1.5 standard, or in case of trouble to commence CPB, propofol will be replaced by midazolam in a dose 0.2-0.3 mg/kg/hour.

During anesthesia, first post-operative day and hospital stay a total of 278 variables will be recorded: hemodynamic parameters, iv fluid doses, inotropes, vasopressors, diuretics, urine output, transfusions, etc.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury in Adult Cardiac Surgical Patients Operated on Cardiopulmonary Bypass
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
BRAIN+THENAR MUSCLE INVOS
Patients undergoing open heart surgery on cardiopulmonary bypass.
Procedure: Open heart surgery on cardiopulmonary bypass.
Brain oximetry and tissue saturation will be measured during operation. NGAL, cystatin-C, and Acute Kidney Injury Network (AKIN) criteria of AKI will be assessed durin first post-op day.




Primary Outcome Measures :
  1. NGAL [ Time Frame: 3 hours after operation ]
    neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples


Secondary Outcome Measures :
  1. NGAL on second day [ Time Frame: second post-op day morning ]
    neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples

  2. Cystatin C [ Time Frame: second post-op day morning ]
    Cystatin-C measured in blood samples

  3. Serum creatinine [ Time Frame: second post-op day morning ]
    Serum creatinine in serum

  4. Acute renal failure [ Time Frame: 30 day / any time after operation before discharge from hospital ]
    Acute renal failure requiring renal replacement therapy or AKIN stage 3

  5. In hospital mortality [ Time Frame: 30 day / any time after operation before discharge from hospital ]
    Death from any reason.


Biospecimen Retention:   Samples Without DNA
Serum from blood samples obtained at 10 timepoints before, during, and after the cardiac surgical operation.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patient scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).
Criteria

Inclusion Criteria:

  • adult patients
  • signed informed consent
  • scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).

Exclusion Criteria:

  • chronic kidney insufficiency (serum creatinine >2 mg/dL)
  • active infection (i.e.: endocarditis)
  • shock or tissue hypoperfusion before operation (blood lactate >3 mmol/L)
  • left ventricle ejection fraction <25%
  • vancomycin used for infection prophylaxis (i.e.: in immunosuppressed patients)
  • history of ischaemic shock

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979275


Contacts
Contact: Romuald Lango, M.D., Ph.D. +48583492483 rlango@gumed.edu.pl
Contact: Maciej Kowalik, M.D., Ph.D. +48583492483 mkowalik@gumed.edu.pl

Locations
Poland
Medical University of Gdańsk, Department of Cardiac Anesthesiology Recruiting
Gdansk, Pomorskie, Poland, 80-211
Contact: Romuald Lango, M.D., Ph.D.    +48583492483    rlango@gumed.edu.pl   
Contact: Maciej Kowalik, M.D., Ph.D.    +48583492483    mkowalik@gumed.edu.pl   
Sub-Investigator: Wiktor Szymanowicz, M.D.         
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Study Director: Romuald Lango, M.D., Ph.D. Medical University of Gdańsk, Department of Cardiac Anesthesiology

Responsible Party: Romuald Lango, Dr hab. med. Romuald Lango, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT02979275     History of Changes
Other Study ID Numbers: NKEBN/122/2014
grant ST-44 ( Other Grant/Funding Number: Medical University of Gdansk )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.

Keywords provided by Romuald Lango, Medical University of Gdansk:
acute kidney injury
cardiopulmonary bypass
neutrophil gelatinase-associated lipocalin
tissue hypoxia

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Heart Valve Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heart Diseases
Cardiovascular Diseases