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:	NCT02666703
Date of registration:	17/01/2016
Prospective Registration:	Yes
Primary sponsor:	University Medical Centre Ljubljana
Public title:	Extracorporeal Cytokine Adsorption in Cardiac Surgery IMEECCACS
Scientific title:	Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery
Date of first enrolment:	February 1, 2016
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02666703
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	Phase 3

Countries of recruitment
Slovenia

Contacts

Name:	Maja Sostaric, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University Medical Centre Ljubljana

Name:	Tomislav Klokocovnik, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University Medical Centre Ljubljana

Name:	Gordana Taleska, MD, MSc
Address:
Telephone:
Email:
Affiliation:	University Medical Centre Ljubljana

Name:	Matej Podbregar, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University Medical Centre Ljubljana

Key inclusion & exclusion criteria

Inclusion Criteria:

- Elective complex cardiac surgery (combined valve and coronary bypass grafting surgery,
concomitant valve surgery, surgery of the ascending aorta and aortic arch, as well as
re-operations of the same type)

- Age > 18 years

Exclusion Criteria:

- Disagreement to participate in the study

- Age < 18 years

- Pregnancy

- Emergency procedure

- Heart transplantation

- Implantation of LVAD (left ventricular assist device), RVAD (right ventricular assist
device) or TAH (total artificial heart)

- Treatment with chemotherapy, immunosuppressive therapy

- Treatment with anti-leukocyte drugs or TNF-alfa blockers

- Immunocompromised patients (AIDS), leucopenia (< 4,0x109 / L)

- Clinical and/or laboratory signs of infection (CRP >2 mg/dl)

- Serum creatinine >2 mg/dl

- Bilirubin >2 mg/dl

- History of stroke

- Malnourished patients, BMI < 18

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiopulmonary Bypass

Intervention(s)

Device: CytoSorb

Drug: Methylprednisolone

Primary Outcome(s)

Evolution of miRNA [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Evolution of PON1, HDL and LDL [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Evolution of complement C5a [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Evolution of CD 64 and CD 163 markers [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Evolution of pro-inflammatory and anti-inflammatory cytokines [TNF-alfa, IL-1, IL-6, IL-8 and IL-10 [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Secondary Outcome(s)

Changes in serum albumin and fibrinogen [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Changes in white blood count [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Changes in serum hs-CRP [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Changes in serum PCT [Time Frame: 1) before induction of anesthesia; 2)at the end of CPB; 3) at the end of surgical procedure; 4) 24 h; 5) 48 h; 6) 5th postoperative day); only for Study group-1 h after start of CPB: 7)from blood entering CytoSorb and 8)from blood leaving CytoSorb]

Secondary ID(s)

ARRS-RPROJ-2014-191

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Slovenian Research Agency

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.