Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001176257
Ethics application status
Approved
Date submitted
8/06/2018
Date registered
16/07/2018
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Value of circulating molecular biomarkers (microRNAs) in perioperative period of abdominal sepsis
Scientific title
Evaluation of systemic inflammatory response and ischemic heart disease effects on the cardiovascular system and perioperative anesthetic management
Secondary ID [1] 295008 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal sepsis 308137 0
peritonitis 308138 0
ishemic heart disease 308139 0
Systemic inflammatory response syndrome 308140 0
acute coronary syndrome 308141 0
Condition category
Condition code
Infection 307172 307172 0 0
Other infectious diseases
Cardiovascular 307175 307175 0 0
Coronary heart disease
Anaesthesiology 307176 307176 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will involve patients with abdominal sepsis, who are going surgery intervention, patients with acute coronary syndrome and patients without inflammation,non infection SIRS, ischemic heart disease, who are going minor elective surgery. We will collect data describing demographics, severity of illness (SOFA; APACHE II scores). Blood samples will be collected at the time of other standard-care assessments to minimize/eliminate the need for additional punctures in the first 24 hours of hospitalization. Blood samples from patients, who are going minor elective surgery, will be taken during venous puncture before the surgery intervention. Up to 30 ml of blood will be collected for measuring the levels of biomarkers expression. Follow up will occur within first 48 hours, death or hospitalization period up to 60 days.
Intervention code [1] 301411 0
Not applicable
Comparator / control treatment
We will not provide control treatment for patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306146 0
Composite expression levels of miR-146a, miR-30d, miR-23a in patients with different severity of abdominal sepsis. RNA extraction kits will be using for extracting microRNA from blood serum. Levels of microRNA's expression will be assessed with PCR.
Timepoint [1] 306146 0
Blood samples will be taken within the first 24 hours after hospitalization
Primary outcome [2] 306191 0
Composite expression levels of miR-146a, miR-30d, miR-23a in patients with acute cardiovascular syndrome. RNA extraction kits will be using for extracting microRNA from blood serum. Levels of microRNA's expression will be assessed with PCR.
Timepoint [2] 306191 0
Blood samples will be taken within the first 24 hours after hospitalization
Primary outcome [3] 306192 0
Composite expression levels of miR-146a, miR-30d, miR-23a in patients without cardiovascular dysfunction or inflammation . RNA extraction kits will be using for extracting microRNA from blood serum. Levels of microRNA's expression will be assessed with PCR.
Timepoint [3] 306192 0
Blood samples will be taken within the first 24 hours after hospitalization
Secondary outcome [1] 347812 0
Differential value of miR-146a, miR-30d, miR-23a in patients with different severity of abdominal sepsis and acute cardiovascular syndrome with high inflammatory biomarkers. Levels of microRNA's expression will be assessed with PCR. The expression will be compared using the statistical package.
Timepoint [1] 347812 0
Duration of hospital stay

Eligibility
Key inclusion criteria
Patients with abdominal sepsis (peritonitis) who undergo abdominal surgery, Patients with acute cardiovascular syndrome and high inflammatory biomarkers. Patients without inflammation,non infection SIRS, ischemic heart disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Oncological disease, pegnancy, refusal for participation, prisoners

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10535 0
Lithuania
State/province [1] 10535 0
Kaunas

Funding & Sponsors
Funding source category [1] 299592 0
University
Name [1] 299592 0
Lithuanian University of Health Sciences
Country [1] 299592 0
Lithuania
Funding source category [2] 299712 0
Hospital
Name [2] 299712 0
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Country [2] 299712 0
Lithuania
Primary sponsor type
Individual
Name
Andrius Macas
Address
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eiveniu g. 2, Kaunas 50009
Country
Lithuania
Secondary sponsor category [1] 299044 0
Individual
Name [1] 299044 0
Tomas Bukauskas
Address [1] 299044 0
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eiveniu g. 2, Kaunas 50009
Country [1] 299044 0
Lithuania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300492 0
Kaunas Regional Biomedical Research Ethics Committee
Ethics committee address [1] 300492 0
A. Mickeviciaus g. 9, LT-44307 Kaunas Lithuania
Ethics committee country [1] 300492 0
Lithuania
Date submitted for ethics approval [1] 300492 0
01/02/2016
Approval date [1] 300492 0
09/05/2016
Ethics approval number [1] 300492 0
BE-2-19

Summary
Brief summary
There is not enough data in the medical literature to distinguish whether a systemic inflammatory response is caused by an infectious agent or aseptic inflammation due to acute coronary syndrome, especially during the perioperative period. Attention is drawn to microRNAs whose expression changes in patients with the infectious disease.
The study will include 100 patients older than 18 years, who have the abdominal sepsis (peritonitis) and are going abdominal surgery intervention, patients with acute cardiovascular syndrome and high inflammatory biomarkers, patients without inflammation, ischemic heart disease who are who are going for minor elective surgery. All patients will be provided with complete study information before being asked to provide consent.
We will collect data describing demographics, severity of illness (SOFA; APACHEII scores). Blood samples will be collected at the time of other standard-care assessments to minimize/eliminate the need for additional punctures in the first 24 hours of hospitalization. Up to 30 ml of blood will be collected for measuring the levels of biomarkers expression. Follow up will occur until the end of active surveillance, death or hospitalization period. Blood samples will be taken within the first 24 hours after hospitalization.
The expression of microRNAs will be assessed in patients with different severity of abdominal sepsis, acute cardiovascular syndrome with high inflammatory biomarkers and control patients without cardiovascular dysfunction or inflammation. RNA extraction kits will be using for extracting microRNA from blood serum. Levels of microRNA's expression will be assessed with PCR. We will assess differential value of microRNAs in patients with different severity of abdominal sepsis and acute cardiovascular syndrome with high inflammatory biomarkers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83834 0
Prof Andrius Macas
Address 83834 0
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eiveniu g. 2, Kaunas 50009, Kaunas
Country 83834 0
Lithuania
Phone 83834 0
+37068639123
Fax 83834 0
Email 83834 0
[email protected]
Contact person for public queries
Name 83835 0
Tomas Bukauskas
Address 83835 0
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eiveniu g. 2, Kaunas 50009, Kaunas
Country 83835 0
Lithuania
Phone 83835 0
+37061473836
Fax 83835 0
Email 83835 0
[email protected]
Contact person for scientific queries
Name 83836 0
Tomas Bukauskas
Address 83836 0
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eiveniu g. 2, Kaunas 50009, Kaunas
Country 83836 0
Lithuania
Phone 83836 0
+37061473836
Fax 83836 0
Email 83836 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.