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

NCT ID: NCT03784521

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2023-06-30

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.

Conditions

SIRS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

In-line filtration

Intervention Type: DEVICE

In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: DEVICE

Patients are treated with standard intravenous solutions and vascular access management

Interventions

In-line filtration

In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.

Intervention Type: DEVICE

Standard care

Patients are treated with standard intravenous solutions and vascular access management

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Narongrit Kantathut, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi hospital, Mahidol University

Locations

Ramathibodi Hospital

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 25845941 (View on PubMed)

Other Identifiers

116064

Identifier Type: -

Identifier Source: org_study_id