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Completed

NCT Number: NCT03135457

TACO Crossover TRIAL

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.

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Key information

Conditions

Transfusion-associated Circulatory Overload Blood Transfusion Reaction Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Transfusion Reaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academisch Medisch Centrum - Universiteit van Amsterdam

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Elective (non-redo) coronary arterial bypass grafting surgery
  • Reduced left ventricular ejection fraction (<55%)
  • Transfusion of autologous blood (cell saver blood, 300ml, HCT60%, 30min)
  • Informed consent

Exclusion criteria

  • Patients with no indication for autologous RBC transfusion
  • Patients with pulmonary hypertension, congenital heart disease, mitral or tricuspid valve disease.
  • Contraindications for PAC placement; coagulopathy, bundle branch block, defibrillator or pacemaker (risk of displacement). External pacemaker placed during surgery is no exclusion criterium.
  • Patients for acute, non-elective surgery
  • Chronic kidney disease stage 4 or higher (eGFR < 30)
  • Massive transfusion
  • Previous randomization in the current trial
  • Postoperative ongoing bleeding
  • Bypass duration > 2 hours
  • Infusion of high dose corticosteroids
  • 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
  • Severe arrhythmias
  • Development of severe pulmonary edema during infusion of autologous blood or saline.
  • Elevated liver enzymes
  • Iodine allergy

Treatment and study plan

Autologous RBC transfusion

Procedure

Autologous RBC transfusion 300ml 10 ml/min

Saline transfusion

Procedure

Saline transfusion 300ml 10ml/min

Primary outcomes

  1. Hydrostatic pressure overload

    Time frame: 1 hour

    Hydrostatic pressure overload defined as delta pulmonary capillary wedge pressure

Secondary outcomes

  1. Capillary leakage

    Time frame: 1 hour

    Capillary leakage defined as delta extra vascular lung water index

  2. Cardiac output

    Time frame: 1 hour

    Volume overload measured by cardiac output

  3. Mean arterial pressure

    Time frame: 1 hour

    Volume overload measured by mean arterial pressure

  4. Pulse pressure variation

    Time frame: 1 hour

    Volume overload measured by pulse pressure variation

  5. Stroke volume variation

    Time frame: 1 hour

    Volume overload measured by stroke volume variation

  6. Extra vascular lung water index

    Time frame: 1 hour

    Volume overload measured by extra vascular lung water index

  7. Systemic vascular resistance

    Time frame: 1 hour

    Volume overload measured by systemic vascular resistance

  8. Colloid osmotic pressure

    Time frame: 1 hour

    Colloid osmotic pressure measured by membrane colloid osmometer

  9. Estimated circulating volume

    Time frame: 1 hour

    Estimated circulating blood volume measured by indocyanine green

  10. Estimated circulating volume

    Time frame: 1 hour

    Estimated circulating plasma volume measured by indocyanine green

  11. Microcirculation

    Time frame: 1 hour

    Total vessel density in the sublingual microcirculation measured by Cytocam

  12. Microcirculation

    Time frame: 1 hour

    Perfused vessel density in the sublingual microcirculation measured by Cytocam

  13. Microcirculation

    Time frame: 1 hour

    Proportion of perfused vessels in the sublingual microcirculation measured by Cytocam

  14. Microcirculation

    Time frame: 1 hour

    Microvascular flow index in the sublingual microcirculation measured by Cytocam

  15. Microcirculation

    Time frame: 1 hour

    Blood vessel diameters in the sublingual microcirculation measured by Cytocam

  16. Fluid responsiveness

    Time frame: 1 hour

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

  17. TACO

    Time frame: 6 hours

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

A Cross-over Randomized Controlled Trial; Pulmonary Edema Detection After Fluid Loading With Blood Versus Saline in Patients After CABG

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 1, 2017
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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