Cytokine adsorption for vasoplegic syndrome after cardiothoracic surgery

Completed

Conditions: paralysis of the blood vessels
Vasoplegia
10011954

Registration Number: NL-OMON55605

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. >= 18 year
2. Post elective cardiac surgery
3. Vasoplegic syndrome occurring within 12 hours after surgery, defined as:
a. High vasopressor dose (norepinephrin > 0.25 mcg/kg/min) needed for adequate
MAP (> 65 mmHg) despite adequate crystalloid fluid resuscitation (> 30 ml/kg
IBW), persisting more than one hour.
b. Echocardiographic evidence of adequate cardiac output, defined as cardiac
index > 2,5L/min/m2. Stroke volume is calculated as the product of Aortic
velocity time integral and left ventricular outflow tract diameter. Cardiac
output is calculated by multiplying stroke volume with heart rate. This is then
divided by body surface area to obtain cardiac index. , c. IF; a pulmonary
artery catheter was already inserted perioperatively:
- Cardiac index > 2,5l/min/m2 AND low systemic vascular resistance (SVRI < 1600
dynes/sec/cm5/m2 , SVR < 800 dynes/sec/cm5)
- OR; normalized vascular resistance at due to high-dose vasopressor use
(norepinephrin > 0.25 mcg/kg/min).

Exclusion Criteria

- Severe coagulopathy resulting in hemodynamic instability
- Significant bleeding defined as 400 ml/1st hour, 200 ml/ 2nd hour, 100 ml/h;
necessitating rethoractomy or transfusion
- Severe thrombocytopenia (< 80)
- Cardiac tamponade
- Active infectious disease (non-profylactic antibiotics)
- Active inflammatory disorders or chronic use of immunosuppressive medication
- Need for extracorporeal life support system
- Severe renal dysfunction pre-operation (GFR <30) or prior kidney transplant
- Contra-indications for PiCCO: Atrial or ventricular arrhythmia at time of
inclusion, Intra-Aortic Balloon pump, Aortic aneurysm, Pneumonectomy, Pulmonary
embolism, Intracardiac shunt
- Allergy for: polystyrene/divinylbenzene, polycarbonate, polypropylene,
silicone and polyester
- Acute liver failure with blood transaminases values >1000 IU/L
- Pregnancy