Acute Kidney InjuryNCT02979275
Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury
An observational study of Acute Kidney Injury and Heart Valve Diseases, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Heart Valve Diseases
- What is being tested?
- Open heart surgery on cardiopulmonary bypass.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Gdansk, Pomeranian Voivodeship, 80-211
Romuald Lango, M.D., Ph.D., +48583492483, rlango@gumed.edu.pl
Maciej Kowalik, M.D., Ph.D., +48583492483, mkowalik@gumed.edu.pl
About this study
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
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Heart Valve Diseases
- Being tested
- Open heart surgery on cardiopulmonary bypass.
- Keywords
- acute kidney injury, cardiopulmonary bypass, neutrophil gelatinase-associated lipocalin, tissue hypoxia
- Medical subject headings
- Acute Kidney Injury, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open heart surgery on cardiopulmonary bypass.Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| BRAIN+THENAR MUSCLE INVOS | Patients undergoing open heart surgery on cardiopulmonary bypass. Receives: Procedure: Open heart surgery on cardiopulmonary bypass. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGAL
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
Measured: 3 hours after operation
Secondary outcomes (5)
NGAL on second day
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
Measured: second post-op day morning
Cystatin C
Cystatin-C measured in blood samples
Measured: second post-op day morning
Serum creatinine
Serum creatinine in serum
Measured: second post-op day morning
Acute renal failure
Acute renal failure requiring renal replacement therapy or AKIN stage 3
Measured: 30 day / any time after operation before discharge from hospital
In hospital mortality
Death from any reason.
Measured: 30 day / any time after operation before discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romuald Lango, Medical University of Gdansk
- Investigators
- Romuald Lango, M.D., Ph.D., Study director, Medical University of Gdańsk, Department of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979275
- Sponsor's protocol ID
- NKEBN/122/2014
- Other IDs
- grant ST-44
- Status last verified
- Apr 2018
- First submitted
- 21 Nov 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02979275
- Acronym / sponsor ID
- NKEBN/122/2014
- Conditions
- Acute Kidney Injury, Heart Valve Diseases
- Keywords
- acute kidney injury, cardiopulmonary bypass, neutrophil gelatinase-associated lipocalin, tissue hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRAIN+THENAR MUSCLE INVOS | – | Procedure: Open heart surgery on cardiopulmonary bypass.Patients undergoing open heart surgery on cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | BRAIN+THENAR MUSCLE INVOS |
Primary outcome
NGAL
Time frame: 3 hours after operation
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
5 secondary outcomes
NGAL on second day
Time frame: second post-op day morning
Cystatin C
Time frame: second post-op day morning
Serum creatinine
Time frame: second post-op day morning
Acute renal failure
Time frame: 30 day / any time after operation before discharge from hospital
In hospital mortality
Time frame: 30 day / any time after operation before discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romuald Lango, M.D., Ph.D. study director
Medical University of Gdańsk, Department of Cardiac Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Heart Valve Diseases, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romuald Lango, M.D., Ph.D. (+48583492483, rlango@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGAL (time frame: 3 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.