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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

Tracking Information
First Submitted Date November 21, 2016
First Posted Date December 1, 2016
Last Update Posted Date April 12, 2018
Actual Study Start Date October 2015
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2016)
NGAL [ Time Frame: 3 hours after operation ]
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02979275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 28, 2016)
  • NGAL on second day [ Time Frame: second post-op day morning ]
    neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
  • Cystatin C [ Time Frame: second post-op day morning ]
    Cystatin-C measured in blood samples
  • Serum creatinine [ Time Frame: second post-op day morning ]
    Serum creatinine in serum
  • 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
  • In hospital mortality [ Time Frame: 30 day / any time after operation before discharge from hospital ]
    Death from any reason.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury
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
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum from blood samples obtained at 10 timepoints before, during, and after the cardiac surgical operation.
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).
Condition
  • Acute Kidney Injury
  • Heart Valve Diseases
Intervention 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.
Study Groups/Cohorts BRAIN+THENAR MUSCLE INVOS
Patients undergoing open heart surgery on cardiopulmonary bypass.
Intervention: Procedure: Open heart surgery on cardiopulmonary bypass.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02979275
Other Study ID Numbers NKEBN/122/2014
grant ST-44 ( Other Grant/Funding Number: Medical University of Gdansk )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Romuald Lango, Medical University of Gdansk
Study Sponsor Medical University of Gdansk
Collaborators Not Provided
Investigators
Study Director: Romuald Lango, M.D., Ph.D. Medical University of Gdańsk, Department of Cardiac Anesthesiology
PRS Account Medical University of Gdansk
Verification Date April 2018