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Cytokine adsorption for vasoplegic syndrome after cardiothoracic surgery

Cytokine adsorption for vasoplegic syndrome after cardiothoracic surgery - CYTATION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55605
Enrollment
40
Registered
2018-11-28
Start date
2019-07-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paralysis of the blood vessels Vasoplegia

Interventions

Treatment with cytokine adsorption in addition to standard treatment.

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 0.25 mcg/kg/min).

Exclusion criteria

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 (1000 IU/L - Pregnancy

Design outcomes

Primary

MeasureTime frame
Cumulative vasopressor need and total amount of fluid administration.

Secondary

MeasureTime frame
Time to hemodynamic stabilization, ICU length of stay, hospital length of stay, mortality, incidence of acute kidney injury and need for renal replacement treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)