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

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.

Study Overview

• Status: Completed
• Conditions: SIRS
• Intervention / Treatment: Device: In-line filtration; Device: Standard care

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.

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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 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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Narongrit Kantathut, MD, Ramathibodi Hospital, Mahidol University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SIRS; Cardiac surgery; In-line filtration
• Other Study ID Numbers: 116064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No