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
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury Heart Valve Diseases||Procedure: Open heart surgery on cardiopulmonary bypass.|
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|
|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|
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.
- NGAL [ Time Frame: 3 hours after operation ]neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979275
|Contact: Romuald Lango, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Maciej Kowalik, M.D., Ph.D.||+email@example.com|
|Medical University of Gdańsk, Department of Cardiac Anesthesiology||Recruiting|
|Gdansk, Pomorskie, Poland, 80-211|
|Contact: Romuald Lango, M.D., Ph.D. +48583492483 firstname.lastname@example.org|
|Contact: Maciej Kowalik, M.D., Ph.D. +48583492483 email@example.com|
|Sub-Investigator: Wiktor Szymanowicz, M.D.|
|Study Director:||Romuald Lango, M.D., Ph.D.||Medical University of Gdańsk, Department of Cardiac Anesthesiology|