Blood Transfusion Reaction, Transfusion-associated Circulatory Overload
Conditions
Brief summary
This is an open-label, prospective crossover randomized controlled trial to investigate wether TACO is solely hydrostatic pressure overload or arises from a combination of hydrostatic pressure overload and capillary leakage, by investigating the difference in change in static pressure parameters (PCWP), dynamic volume parameters (PICCO) as indirect measurements of volume status and capillary leakage after autologous transfusion or saline infusion. The investigators will estimate effective circulating volume following autologous transfusion or saline infusion. Furthermore, the investigators will investigate the effect of fluid loading on the microcirculation.
Detailed description
Coronary arterial bypass grafting surgery patients with reduced left ventricular function 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 start of the intervention, 15 minutes following start of infusion and a the end of infusion, the investigators will measure right-ventricular pressure and wedge pressure (PCWP), as well as extravascular lung water index (EVLWI) and CO estimation through PICCO® and Pulmonary Artery Catheter. The investigators will identify fluid responsiveness by performing a passive leg raise test (PLR). The investigators aim to measure total vessel density (TVD), perfused vessel density (PVD), proportion of perfused vessels (PPV), microvascular flow index (MFI), and blood vessel diameters (Øbv) from the oral microcirculation by CytoCam microscope system. The investigators will estimate the effective circulating blood and plasma volume through dilutional infusion of indocyanine green prior to initial infusion, between and at the end of subsequent infusion.
Interventions
PROCEDUREAutologous RBC transfusion
Autologous RBC transfusion 300ml 10 ml/min
PROCEDURESaline transfusion
Saline transfusion 300ml 10ml/min
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Masking of investigator is not possible due to nature of intervention.
Intervention model description
Open-label, prospective cross-over randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years 2. Elective (non-redo) coronary arterial bypass grafting surgery 3. Reduced left ventricular ejection fraction (\<55%) 4. Transfusion of autologous blood (cell saver blood, 300ml, HCT60%, 30min) 5. Informed consent
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 \< 30) 6. Massive transfusion 7. Previous randomization in the current trial 8. Postoperative ongoing bleeding 9. Bypass duration \> 2 hours 10. Infusion of high dose corticosteroids 11. Hemodynamic instability with a mean arterial pressure (MAP) \< 60 mmHg, central venous pressure \> 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 | Description |
|---|---|---|
| Hydrostatic pressure overload | 1 hour | Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output | 1 hour | Volume overload measured by cardiac output |
| Mean arterial pressure | 1 hour | Volume overload measured by mean arterial pressure |
| Pulse pressure variation | 1 hour | Volume overload measured by pulse pressure variation |
| Stroke volume variation | 1 hour | Volume overload measured by stroke volume variation |
| Extra vascular lung water index | 1 hour | Volume overload measured by extra vascular lung water index |
| Capillary leakage | 1 hour | Capillary leakage defined as delta extra vascular lung water index |
| Colloid osmotic pressure | 1 hour | Colloid osmotic pressure measured by membrane colloid osmometer |
| Estimated circulating volume | 1 hour | Estimated circulating blood volume measured by indocyanine green |
| Microcirculation | 1 hour | Total vessel density in the sublingual microcirculation measured by Cytocam |
| Fluid responsiveness | 1 hour | Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output \> 10%) |
| TACO | 6 hours | Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion |
| Systemic vascular resistance | 1 hour | Volume overload measured by systemic vascular resistance |
Countries
Netherlands
Outcome results
None listed