Status:

RECRUITING

Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb.

Lead Sponsor:

Leiden University Medical Center

Conditions:

Heart Failure

Vasoplegia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Vasoplegia is a common complication after heart surgery for heart failure. With vasoplegia, the blood vessels can no longer squeeze properly, causing low blood pressure that is sometimes difficult to ...

Detailed Description

The incidence and prevalence of chronic heart failure is increasing. Despite the expansion of therapeutic options, overall survival and quality-of-life remain poor. When optimal medical therapy and ca...

Eligibility Criteria

Inclusion

  • Diagnosed with HF in line with the European Society of Cardiology (ESC) guidelines34;
  • Left ventricular EF ≤35%;
  • Undergoing cardiac surgery on CPB with an anticipated duration of \>120 minutes;
  • Age ≥18 years.

Exclusion

  • Incapacitated;
  • Emergency operation;
  • Need for moderate or high dosages of intravenous inotropic support (\>4 gamma dobutamine or dopamine) and/or vasopression;
  • Severe tricuspid regurgitation;
  • Daily use of nitroglycerine or isosorbide dinitrate;
  • Use of alpha blockers;
  • Being heparin-induced thrombocytopenia (HIT) positive and citrate regional anticoagulation is unavailable as an alternative anticoagulation method;
  • Platelet count \<20,000/μL.

Key Trial Info

Start Date :

October 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT04812717

Start Date

October 27 2021

End Date

January 31 2026

Last Update

December 13 2023

Active Locations (1)

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Leiden University Medical Center

Leiden, Netherlands