Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury
2 other identifiers
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedApril 12, 2018
April 1, 2018
3 years
November 21, 2016
April 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NGAL
neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
3 hours after operation
Secondary Outcomes (5)
NGAL on second day
second post-op day morning
Cystatin C
second post-op day morning
Serum creatinine
second post-op day morning
Acute renal failure
30 day / any time after operation before discharge from hospital
In hospital mortality
30 day / any time after operation before discharge from hospital
Study Arms (1)
BRAIN+THENAR MUSCLE INVOS
Patients undergoing open heart surgery on cardiopulmonary bypass.
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Gdansk, Pomeranian Voivodeship, 80-211, Poland
Biospecimen
Serum from blood samples obtained at 10 timepoints before, during, and after the cardiac surgical operation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Romuald Lango, M.D., Ph.D.
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr hab. med. Romuald Lango
Study Record Dates
First Submitted
November 21, 2016
First Posted
December 1, 2016
Study Start
October 1, 2015
Primary Completion
October 1, 2018
Study Completion
November 1, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04