ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02979275
Date of registration:	21/11/2016
Prospective Registration:	No
Primary sponsor:	Medical University of Gdansk
Public title:	Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury
Scientific 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
Date of first enrolment:	October 2015
Target sample size:	100
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT02979275
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Poland

Contacts

Name:	Romuald Lango, M.D., Ph.D.
Address:
Telephone:
Email:
Affiliation:	Medical University of Gdansk, Department of Cardiac Anesthesiology

Name:	Romuald Lango, M.D., Ph.D.
Address:
Telephone:	+48583492483
Email:	rlango@gumed.edu.pl
Affiliation:

Name:	Romuald Lango, M.D., Ph.D.
Address:
Telephone:	+48583492483
Email:	rlango@gumed.edu.pl
Affiliation:

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Valve Diseases

Acute Kidney Injury

Intervention(s)

Procedure: Open heart surgery on cardiopulmonary bypass.

Primary Outcome(s)

NGAL [Time Frame: 3 hours after operation]

Secondary Outcome(s)

NGAL on second day [Time Frame: second post-op day morning]

Serum creatinine [Time Frame: second post-op day morning]

Cystatin C [Time Frame: second post-op day morning]

In hospital mortality [Time Frame: 30 day / any time after operation before discharge from hospital]

Acute renal failure [Time Frame: 30 day / any time after operation before discharge from hospital]

Secondary ID(s)

NKEBN/122/2014

grant ST-44

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.