Clinical trial NCT03784521: Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery
Official title: Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SIRS
Keywords: SIRS
In-line filtration
Cardiac surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to demonstrated efficacy of in-line filtration to reduce systemic inflammatory response syndrome (SIRS) ,specific organ dysfunction and complications in adult cardiac surgery. 486 patients undergoing cardiac surgery for acquired heart disease are 1:1 randomized into in-line filtration (study group) and non-filtration (control group). The incidence of SIRS, complications, daily SOFA (sequential organ failure assessment) score are compared between groups.

Detailed description: This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 11-60-64) with informed consent required for all patients.

The incidences of SIRS between the control and the filter group in pediatrics population from previous study were 35% and 25.2% respectively (risk difference -11.3%, 95% CI -21.8 to -0.5%). The author estimated the sample size of 486 randomized patients to give 80% power at the 10% significant level (alpha 0.1, beta 0.8).

Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting (CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into in-line filtration (study group) and non-filtration (control group).

For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used for all intravenous access during operation and postoperative period in intensive care unit (ICU).

For patients randomized to control group, All intravenous access is managed routinely according to local standard care without filtration during operation and postoperative period in ICU.

Primary endpoint of this study is the incidence of SIRS after cardiac surgery. SIRS is diagnosed when patients have two or more of these criteria: 1.Heart rate \>90/min, 2.Temperature \>38 °C or \<36 °C, 3.Respiratory rate \>20/min or Paco2 \<32 mm Hg (4.3 kPa), and 4.White blood cell count \>12000/mm3 or \<4000/mm3 or \>10% immature band.

Secondary endpoints are complications as defined by Society of Thoracic Surgeons (STS) Adult Cardiac Surgical Database, daily SOFA score and organ dysfunction as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Continuous data were reported as mean (standard deviation, SD) or median (interquartile range, IQR) and compared by independent sample t-test or the Mann-Whitney U test. Categorical variables were presented as frequency (%) and analyzed by chi-squared or Fisher's exact test. Statistical significance was defined as a P-value \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 years or older undergoing elective adult cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Patient who does not want to participate in the study

Primary outcomes:
measure: Incidence of SIRS after cardiac surgery
timeFrame: SIRS is evaluated every 24 hours from immediate post-op to 96 hours postoperatively
Secondary outcomes:
measure: Daily SOFA score
timeFrame: SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively
measure: Incidence of Operative mortality
timeFrame: up to 1 month postoperatively
measure: Incidence of Permanent Stroke
timeFrame: up to 1 month postoperatively
measure: Incidence of Renal Failure
timeFrame: up to 1 month postoperatively
measure: Incidence of Prolonged Ventilation > 24 hours
timeFrame: up to 1 month postoperatively
measure: Incidence of Deep sternal wound infection
timeFrame: up to 1 month postoperatively
measure: Incidence of Reoperation for any reason
timeFrame: up to 1 month postoperatively
measure: Incidence of Major Morbidity or Operative Mortality
timeFrame: up to 1 month postoperatively
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi hospital, Mahidol University
name: Narongrit Kantathut, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sasse M, Dziuba F, Jack T, Koditz H, Kaussen T, Bertram H, Beerbaum P, Boehne M. In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol. 2015 Aug;36(6):1270-8. doi: 10.1007/s00246-015-1157-x. Epub 2015 Apr 7.