Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery

Conditions
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SIRS

Intervention / Treatment
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* Device: In-line filtration
* Device: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-line filtration<br>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). | Device: In-line filtration<br>* In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.<br>|
| Active Comparator: Control<br>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. | Device: Standard care<br>* Patients are treated with standard intravenous solutions and vascular access management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | SIRS is evaluated every 24 hours from immediate post-op to 96 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily SOFA score | Daily SOFA score and organ dysfunction are as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ has a possible dysfunction score of 0 to 4. | SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively | 
| Incidence of Operative mortality | Operative mortality includes both (1) all deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and (2) those deaths occurring after discharge from the hospital, but within 30 days of the procedure. | up to 1 month postoperatively | 
| Incidence of Permanent Stroke | Postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours. | up to 1 month postoperatively | 
| Incidence of Renal Failure | Acute or worsening renal failure resulting in one or more of the following: Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level. A new requirement for dialysis postoperatively. | up to 1 month postoperatively | 
| Incidence of Prolonged Ventilation > 24 hours | Prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation. | up to 1 month postoperatively | 
| Incidence of Deep sternal wound infection | Deep sternal wound infection or mediastinitis (according to CDC definition) diagnosed within 30 days of the operation or any time during the hospitalization for the surgery. | up to 1 month postoperatively | 
| Incidence of Reoperation for any reason | Reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason | up to 1 month postoperatively | 
| Incidence of Major Morbidity or Operative Mortality | A composite endpoint defined as any of the outcomes listed above, including; Operative mortality, Permanent Stroke, Renal Failure, Prolonged Ventilation > 24 hours, Deep sternal wound infection, Reoperation for any reason. | up to 1 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIRS, In-line filtration, Cardiac surgery