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

NCT03784521 | Completed

• 1 other identifier: 116064
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

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.

Conditions

SIRS

Keywords

SIRS; In-line filtration; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Daily SOFA score

  SOFA score is evaluated every 24 hours from immediate post-op to 96 hours postoperatively

• Incidence of Operative mortality

  up to 1 month postoperatively

• Incidence of Permanent Stroke

  up to 1 month postoperatively

• Incidence of Renal Failure

  up to 1 month postoperatively

• Incidence of Prolonged Ventilation > 24 hours

  up to 1 month postoperatively

Study Arms (2)

In-line filtration

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

In-line filtration DEVICE

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

In-line filtration

Standard care DEVICE

Patients are treated with standard intravenous solutions and vascular access management

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 25845941 BACKGROUND

Study Officials

• Narongrit Kantathut, MD

  Ramathibodi hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 24, 2018
• Study Start: January 3, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)