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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979275
• Other study ID #: NKEBN/122/2014
• Secondary ID: grant ST-44
• Status: Recruiting
• First received: November 21, 2016
• Last updated: April 11, 2018
• Start date: October 2015
• Est. completion date: November 2018

Study information

• Verified date: April 2018
• Source: Medical University of Gdansk
• Contact: Romuald Lango, M.D., Ph.D.
• Phone: +48583492483
• Email: rlango[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Valve Diseases
• Wounds and Injuries

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.

Locations

Country	Name	City	State
Poland	Medical University of Gdansk, Department of Cardiac Anesthesiology	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NGAL	neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples	3 hours after operation
Secondary	NGAL on second day	neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples	second post-op day morning
Secondary	Cystatin C	Cystatin-C measured in blood samples	second post-op day morning
Secondary	Serum creatinine	Serum creatinine in serum	second post-op day morning
Secondary	Acute renal failure	Acute renal failure requiring renal replacement therapy or AKIN stage 3	30 day / any time after operation before discharge from hospital
Secondary	In hospital mortality	Death from any reason.	30 day / any time after operation before discharge from hospital