We aim to investigate the clinical benefit of cytokine adsorption on post-cardiothoracic surgery vasoplegic syndrome.
ID
Source
Brief title
Condition
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cumulative vasopressor need and total amount of fluid administration.
Secondary outcome
Time to hemodynamic stabilization, ICU length of stay, hospital length of stay,
mortality, incidence of acute kidney injury and need for renal replacement
treatment.
Background summary
Vasoplegic syndrome is a frequently occurring complication after cardiac
surgery and is associated with increased mortality and morbidity. It is
attributed to excessive inflammation occurring as a consequence of the
sternotomy wound itself and of the cardiopulmonary bypass. Clinical
observations and case series have shown a beneficial effect of cytokine
adsorption on mortality, vasopressor need and hemodynamic stabilization in both
septic patients and after cardiac surgery, however prospective data is lacking.
Study objective
We aim to investigate the clinical benefit of cytokine adsorption on
post-cardiothoracic surgery vasoplegic syndrome.
Study design
Randomised controlled trial.
Intervention
Treatment with cytokine adsorption in addition to standard treatment.
Study burden and risks
Vasoplegic syndrome is a known and severe complication of cardiothoracic
surgery. Patients are given supportive treatment; adjunctive treatment with
cytokine adsorption may help decrease vasopressor need and increase hemodynamic
stabilization. Patients in the interventional arm will receive hemoadsorption
via a central catheter placed in the femoral vein. The most common complication
of placing a catheter in the femoral vein is hematoma formation. This
complication is rare and usually self-limiting. More severe catheter related
problems such as infection and thrombosis are not to be expected since the
catheter will be removed (after 24h) before these complications typically
occur. A dialysis filter will be placed downstream of the cytokine filter,
monitoring of calcium chelation will be performed according to the local
standard citrate anticoagulation protocol. Patient survival is registered for
30 days after ICU discharge. After ICU discharge there are no additional
burdens associated with participation.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL65440.068.18 |
| Other | nog niet toegekend |