TACO Crossover TRIAL

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hydrostatic pressure overload

Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

Time frame: 1 hour

Secondary Outcomes

Capillary leakage

Capillary leakage defined as delta extra vascular lung water index

Time frame: 1 hour

Cardiac output

Volume overload measured by cardiac output

Time frame: 1 hour

Mean arterial pressure

Volume overload measured by mean arterial pressure

Time frame: 1 hour

Pulse pressure variation

Volume overload measured by pulse pressure variation

Time frame: 1 hour

Stroke volume variation

Volume overload measured by stroke volume variation

Time frame: 1 hour

Extra vascular lung water index

Volume overload measured by extra vascular lung water index

Time frame: 1 hour

Systemic vascular resistance

Volume overload measured by systemic vascular resistance

Time frame: 1 hour

Colloid osmotic pressure

Colloid osmotic pressure measured by membrane colloid osmometer

Time frame: 1 hour

Estimated circulating volume

Estimated circulating blood volume measured by indocyanine green

Time frame: 1 hour

Estimated circulating volume

Estimated circulating plasma volume measured by indocyanine green

Time frame: 1 hour

Microcirculation

Total vessel density in the sublingual microcirculation measured by Cytocam

Time frame: 1 hour

Microcirculation

Perfused vessel density in the sublingual microcirculation measured by Cytocam

Time frame: 1 hour

Microcirculation

Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam

Time frame: 1 hour

Microcirculation

Microvascular flow index in the sublingual microcirculation measured by Cytocam

Time frame: 1 hour

Microcirculation

Blood vessel diameters in the sublingual microcirculation measured by Cytocam

Time frame: 1 hour

Fluid responsiveness

Fluid responsiveness defined by Passive Leg Raise test (increase in cardiac output \> 10%)

Time frame: 1 hour

TACO

Transfusion associated circulatory overload criteria 6 hours after infusion of autologous blood transfusion

Time frame: 6 hours

TACO Crossover TRIAL

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes