SIRS Clinical Trial
Official title:
Efficacy of Intravenous In-line Filter in Patient Undergoing Cardiac Surgery
NCT number | NCT03784521 |
Other study ID # | 116064 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 3, 2019 |
Est. completion date | June 30, 2023 |
Verified date | March 2024 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 486 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Ramathibodi Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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