A Cross-over Randomized Controlled Trial; Pulmonary edema detection after fluid loading with blood versus saline in patients after CABG

A Cross-over Randomized Controlled Trial; Pulmonary edema detection after fluid loading with blood versus saline in patients after CABG - TACO crossover TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47009

Enrollment

Registered

2018-12-20

Start date

2017-08-16

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Transfusion Associated Cardiac Overload Volume-overload

Interventions

Patients will be allocated to either infusion of 300mL saline with a subsequent autologous RBC (cell saver) transfusion of 300 mL at a rate of 10mL/min, or the same in the reversed order. Prior to s

Cardiac Overload

Fluid loading

Pulmonary Edema

Transfusion

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Elective (non-redo) coronary arterial bypass grafting surgery 3. Reduced left ventricular ejection fraction (

Exclusion criteria

Exclusion criteria: 1. Patients with no indication for autologous RBC transfusion 2. Patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease. 3. Contraindications for PAC placement; coagulopathy, bundle branch block, defibrillator or pacemaker (risk of displacement). External pacemaker placed during surgery is no exclusion criterium. 4. Patients for acute, non-elective surgery 5. Chronic kidney disease stage 4 or higher (eGFR 2 hours 10. Infusion of high dose corticosteroids 11. Hemodynamic instability with a mean arterial pressure (MAP) 20 mmHg or dependence on high dosages of inotropic drugs after admittance to the ICU 12. Severe arrhythmias 13. Development of severe pulmonary edema during infusion of autologous blood or saline. 14. Elevated liver enzymes 15. Iodine allergy

Design outcomes

Primary

Measure	Time frame
Hydrostatic pressure overload defined as * PCWP	—

Secondary

Measure	Time frame
Capillary leakage defined as * EVLWI Volume overload measured by Pulmonary artery catheter CO Arterial line / PICCO MAP, PPV, SVV, CO, CI, EVLWI, SVR Colloid osmotic pressure COP by membrane colloid osmometer Estimated circulating volume * PV, * BV Microcirculation measured by CytoCam microscope system TVD, PVD, PPV, MFI, Øbv Fluid responsiveness defined by PLR * CO > 10% TACO criteria 6 hours after infusion of autologous blood transfusion	—

Measure

Time frame

Capillary leakage defined as * EVLWI Volume overload measured by Pulmonary artery catheter CO Arterial line / PICCO MAP, PPV, SVV, CO, CI, EVLWI, SVR Colloid osmotic pressure COP by membrane colloid osmometer Estimated circulating volume * PV, * BV Microcirculation measured by CytoCam microscope system TVD, PVD, PPV, MFI, Øbv Fluid responsiveness defined by PLR * CO > 10% TACO criteria 6 hours after infusion of autologous blood transfusion

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)