CONTINUOUS POSTOPERATIVE PERICARDIAL FLUSHING AFTER GENERAL CARDIAC SURGERY PROCEDURES WITH THE HAERMONICS INVESTIGATIONAL DEVICE : STUDY PROTOCOL OF THE FLUID (FLUsh with Investigational Device) TRIAL

CONTINUOUS POSTOPERATIVE PERICARDIAL FLUSHING AFTER GENERAL CARDIAC SURGERY PROCEDURES WITH THE HAERMONICS INVESTIGATIONAL DEVICE : STUDY PROTOCOL OF THE FLUID (FLUsh with Investigational Device) TRIAL - The FLUID trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54160

Enrollment

992

Registered

2021-05-25

Start date

2021-11-02

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative hemorage

Interventions

One group receives CPPF therapy (inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 8 postoperative hours) executed with the Haermonics Flush investigational devi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults undergoing a general cardiothoracic surgery procedure with the use of cardiopulmonary bypass are eligible for participation

Exclusion criteria

Exclusion criteria: Euroscore II > 20% , Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity, Age

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the incidence of re-exploration for cardiac tamponade and/or excessive bleeding due to non-surgical bleeding	—

Secondary

Measure	Time frame
Blood loss data: Hourly blood loss, Postoperative blood loss after 10-hour stay in the ICU, Postoperative blood loss at chest tube removal Hemoglobin * between randomization and 12-hour stay in the ICU (g/dL), Hemoglobin * between randomization and hospital discharge (g/dL) Number of units transfused after randomization: Red cells, Fresh-frozen plasma, Platelet concentrate Intrapericardial pressure data: CVP during pressure controlled ventilation (5 timepoints within 30 minutes), CVP during pressure support ventilation (5 timepoints within 30 minutes),CVP after extubation (5 timepoints within 30 minutes) Duration of ventilation, hours Fluid accumulation at discharge: postoperative pericardial effusion or pleural effusion LOS ICU and hospital, days Cost (measured in consumed care and products) Time until chest tube removal, hours Intraluminal chest tube clogging Adverse events data: Late cardiac tamponade, reoperation (for: surgical bleeding, other reasons), Minimal invasive intervention for fluid accumulation (pericardial intervention, pleural intervention) Infections (sepsis, pneumonia, deep sternal wound infection, surgical wound infection, sternal dehiscence, acute renal insufficiency, postoperative atrial fibrillation, myocardial infarction, mortality)	—

Measure

Time frame

Blood loss data: Hourly blood loss, Postoperative blood loss after 10-hour stay in the ICU, Postoperative blood loss at chest tube removal Hemoglobin * between randomization and 12-hour stay in the ICU (g/dL), Hemoglobin * between randomization and hospital discharge (g/dL) Number of units transfused after randomization: Red cells, Fresh-frozen plasma, Platelet concentrate Intrapericardial pressure data: CVP during pressure controlled ventilation (5 timepoints within 30 minutes), CVP during pressure support ventilation (5 timepoints within 30 minutes),CVP after extubation (5 timepoints within 30 minutes) Duration of ventilation, hours Fluid accumulation at discharge: postoperative pericardial effusion or pleural effusion LOS ICU and hospital, days Cost (measured in consumed care and products) Time until chest tube removal, hours Intraluminal chest tube clogging Adverse events data: Late cardiac tamponade, reoperation (for: surgical bleeding, other reasons), Minimal invasive intervention for fluid accumulation (pericardial intervention, pleural intervention) Infections (sepsis, pneumonia, deep sternal wound infection, surgical wound infection, sternal dehiscence, acute renal insufficiency, postoperative atrial fibrillation, myocardial infarction, mortality)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)