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

Completed

Conditions: Transfusion Associated Cardiac Overload
Volume-overload
10019280
10037454

Registration Number: NL-OMON47009

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hydrostatic pressure overload defined as * PCWP</p><br>

Secondary Outcome Measures

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