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

NCT04812717 | Unknown DMC

• 2 other identifiers: P20.039NL71623.058.20
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Vasoplegia

Keywords

Heat Failure; Vasoplegia; Cardiopulmonary Bypass; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (2)

• Delta systemic vascular resistance index (SVRi) after CPB.

  The change in SVRi after the administration of phenylephrine after cessation of CPB.

  during surgery (2-10 hours)

• Incidence of vasoplegia.

  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.

  72 hours

Secondary Outcomes (21)

• Delta SVRi in ICU.

  postoperative day 1

• Total administered dosage of vasopressors.

  30 days

• Change in IL-6, IL-8, IL-10 levels.

  until postoperative day 4 (96 hours)

• Change in microvascular flow index [MFI],heterogeneity index [HI].

  until postoperative day 4 (96 hours)

• Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD].

  until postoperative day 4 (96 hours)

Other Outcomes (1)

• Costs.

  30 days

Study Arms (2)

CytoSorb-Yes

ACTIVE COMPARATOR

Heart failure patients that will receive intraoperative treatment with CytoSorb.

Device: CytoSorb device

CytoSorb-No

NO INTERVENTION

Heart failure patients that will not receive intraoperative treatment with CytoSorb.

Interventions

CytoSorb device DEVICE

The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.

CytoSorb-Yes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Related Publications (1)

• Papazisi O, Bruggemans EF, Berendsen RR, Hugo JDV, Lindeman JHN, Beeres SLMA, Arbous MS, van den Hout WB, Mertens BJA, Ince C, Klautz RJM, Palmen M. Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 19;12(9):e061337. doi: 10.1136/bmjopen-2022-061337.

  PMID: 36123067 DERIVED

MeSH Terms

Conditions

Heart Failure; Vasoplegia; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Shock

Study Officials

• Meindert Palmen, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Papazisi, MD

CONTACT

+31715264022; o.papazisi@lumc.nl

Eline F Bruggemans, MSc

CONTACT

+31715264022; e.f.bruggemans@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Perfusionists will not be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Cardiothoracic Surgeon

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 24, 2021
• Study Start: October 27, 2021
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

NL (1)