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

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ClinicalTrials.gov Identifier: NCT04812717
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : November 5, 2021
Information provided by (Responsible Party):
Meindert Palmen, Leiden University Medical Center

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 treat with medication. One of the causes of this complication is likely to be the use of the heart-lung machine, a device that takes over the function of the heart and lungs during surgery. The blood then comes into contact with a foreign environment and this can cause a reaction of the immune system. Patients with heart failure are extra sensitive to this reaction.

CytoSorb device is a filter that can be built into the heart-lung machine and can reduce the response of the immune system. Therefore, this study aims to investigate whether the use of this filter during heart surgery in patients with heart failure results in a less frequent occurrence of vasoplegia after surgery.

Condition or disease Intervention/treatment Phase
Heart Failure Vasoplegia Device: CytoSorb device Not Applicable

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 cardiological interventions have failed to improve a patient's condition, surgical intervention may be a valid option in order to improve cardiac function. Different surgical treatments have improved clinical outcome. Unfortunately, heart failure surgery is associated with an increased risk of vasoplegia. This syndrome is characterized by hypotension and the continuous need of vasopressors, despite a normal or high cardiac index. The incidence of vasoplegia ranges from 11-31% in patients undergoing heart failure surgery. The prognosis of vasoplegia is poor. Prolonged hypotension and the accompanying hypoperfusion lead to end-organ dysfunction and is associated with an increased morbidity and mortality. The investigators hypothesise that the balance of the vascular system of patients with heart failure is fragile and therefore could easily be disturbed by a systemic inflammatory response syndrome (SIRS) caused by the cardiopulmonary bypass (CPB) and surgical trauma, making these patients more prone to develop vasoplegia. Minimising this SIRS reaction could be a strategy to prevent vasoplegia. Therefore, the objective of this single-center, investigator-initiated study is to analyse the efficacy and cost-effectiveness of using CytoSorb in preventing vasoplegia in patients with heart failure undergoing cardiac surgery on CPB.

CytoSorb treatment will be conducted intraoperatively and the device will be applied in a parallel circuit in the CPB. The total study intervention protocol takes 5 days and starts on the day of the surgery (day 0) and ends at day 4 postoperatively. Patient clinical data will be collected until day 30.

The vascular reactivity in response to a vasoconstrictor will be assessed in all patients at 3 different time points (after induction, after CPB, on day 1 postoperatively). During the vasoconstriction test, a bolus of 2 μg/kg phenylephrine is administered intravenously, after which the effect on the systemic vascular resistance is registered. At the same time points and in addition, before induction (baseline) and on day 4 the sublingual microcirculation will be monitored and blood samples will be collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Perfusionists will not be blinded.
Primary Purpose: Prevention
Official Title: Prevention of Vasoplegia With the Use of CytoSorb.
Actual Study Start Date : October 27, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: CytoSorb-Yes
Heart failure patients that will receive intraoperative treatment with CytoSorb.
Device: CytoSorb device
The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.

No Intervention: CytoSorb-No
Heart failure patients that will not receive intraoperative treatment with CytoSorb.

Primary Outcome Measures :
  1. Delta systemic vascular resistance index (SVRi) after CPB. [ Time Frame: during surgery (2-10 hours) ]
    The change in SVRi after the administration of phenylephrine after cessation of CPB.

  2. Incidence of vasoplegia. [ Time Frame: 72 hours ]
    Vasoplegic syndrome defined as the continuous need of vasopressors (norepinephrine ≥0.2 μg/kg/min for at least 12 consecutive hours, terlipressin, or methylene blue) in combination with a cardiac index (CI) ≥2.2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively.

Secondary Outcome Measures :
  1. Delta SVRi in ICU. [ Time Frame: postoperative day 1 ]
    The change in SVR after the administration of phenylephrine during the postoperative day one in the Intensive Care Unit (ICU).

  2. Total administered dosage of vasopressors. [ Time Frame: 30 days ]
  3. Change in IL-6, IL-8, IL-10 levels. [ Time Frame: until postoperative day 4 (96 hours) ]
  4. Change in microvascular flow index [MFI],heterogeneity index [HI]. [ Time Frame: until postoperative day 4 (96 hours) ]
    Heterogeneity index [HI] will be calculated as the difference between the highest MFI minus the lowest MFI and divided by the mean MFI.

  5. Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD]. [ Time Frame: until postoperative day 4 (96 hours) ]
  6. Change in proportion of perfused vessels [PPV]. [ Time Frame: until postoperative day 4 (96 hours) ]
  7. Change in rolling leucocytes [RL] levels. [ Time Frame: until postoperative day 4 (96 hours) ]
  8. Change in mean cell velocity [MCV], red blood cell velocity [RBCv]. [ Time Frame: until postoperative day 4 (96 hours) ]
  9. Change in capillary hematocrit. [ Time Frame: until postoperative day 4 (96 hours) ]
  10. Change in mean arterial pressure (MAP) after phenylephrine administration. [ Time Frame: until postoperative day 1 (24 hours) ]
  11. Hours on mechanical ventilation. [ Time Frame: 30 days ]
  12. Hours on mechanical circulatory support. [ Time Frame: 30 days ]
  13. Hours on postoperative renal replacement therapy. [ Time Frame: 30 days ]
  14. End organ damage (kidney dysfunction). [ Time Frame: 30 days ]
  15. Change in total Sequential Organ Failure Assessment Score (SOFA). [ Time Frame: 30 days ]
  16. Amount of used resuscitation fluids. [ Time Frame: 30 days ]
  17. Amount of used blood transfusion products. [ Time Frame: 30 days ]
  18. Length of ICU stay. [ Time Frame: 30 days ]
  19. Length of hospital stay. [ Time Frame: 30 days ]
  20. 30-Day hospital readmissions. [ Time Frame: 30 days ]
  21. All-cause mortality. [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Costs. [ Time Frame: 30 days ]
    Market prices will be used for the CytoSorb intervention, vasopressor and inotropic medication, amount of blood transfusion products and resuscitation fluids, and reference prices from the Dutch guidelines for economic evaluations in healthcare for duration of surgery, ICU stay, and non-ICU hospital stay, hospital readmissions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812717

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Contact: Olga Papazisi, MD +31715264022 o.papazisi@lumc.nl
Contact: Eline F Bruggemans, MSc +31715264022 e.f.bruggemans@lumc.nl

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Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Olga Papazisi, MD    +31 71 5264022    o.papazisi@lumc.nl   
Principal Investigator: Meindert Palmen, MD PhD         
Sponsors and Collaborators
Leiden University Medical Center
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Principal Investigator: Meindert Palmen, MD, PhD Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meindert Palmen, MD PhD, Cardiothoracic Surgeon, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04812717    
Other Study ID Numbers: P20.039
NL71623.058.20 ( Other Identifier: Central Committee on Research Involving Human Subjects(CCMO) )
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meindert Palmen, Leiden University Medical Center:
Heat Failure
Cardiopulmonary Bypass
Systemic Inflammatory Response Syndrome
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes