Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

NCT03145441 | Completed FDA Device

• 1 other identifier: SU-AITK/VM-2017/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc. On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group. There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (\>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation. The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.

Conditions

Cardiac Transplantation; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (3)

• Early postoperative hemodynamic instability

  Hemodynamic instability described by Vasoactive Inotropic Score and calculated for the first two postoperative days. Vasoactive Inotropic Score is considered as 'high' if values ≥ 30 points, representing higher risk for worse outcomes.

  24-48 hours

• Postoperative vasoplegia syndrome

  Severity of postoperative vasoplegia based on criteria of vasoplegia syndrome: Norepinephrine reqirements ≥ 0.3 μg/kg/min AND arginine vasopressin requirements at any dose

  24-48 hours

• Cytokine and complement levels

  Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements immediately after induction of anesthesia, before initiation of cardiopulmonary bypass (CPB), 2 hours after initiation of CPB, at termination of CPB, 6-12-24 hours after initiation of CPB

  24-48 hours

Secondary Outcomes (7)

• Inflammatory reaction

  24-48 hours

• Mechanical ventilation

  up to 6 months

• Hospital stay

  up to 6 months

• Length of survival

  1 year

• Medical circulatory support

  72 hours

Study Arms (2)

CytoSorb®

EXPERIMENTAL

The CytoSorb® filter will be installed into the cardiopulmonary bypass circle during cardiac transplantation in this study group (30 patients)

Device: CytoSorb®

Control

NO INTERVENTION

No filter will be installed into the cardiopulmonary bypass circle in this group (30 patients).

Interventions

CytoSorb® DEVICE

CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.

CytoSorb®

Eligibility Criteria

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

You may qualify if:

• patients undergoing heart transplantation
• no medical or mechanical circulatory support straight before transplantation
• age \> 18 years

You may not qualify if:

• age \< 18 years
• septic condition (controlled infection) before transplantation
• prolonged hospital stay straight before transplantation
• use of positive inotropes or vasopressors straight before transplantation
• use of mechanical circulatory support straight before transplantation
• acute liver or kidney failure straight before transplantation
• high urgency transplantation
• retransplantation
• the patient declines participating in the study

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Hungary

Location

Related Publications (3)

• Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.

  PMID: 27059056 BACKGROUND

• Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. doi: 10.1097/01.CCM.0000291646.34815.BB.

  PMID: 18090355 BACKGROUND

• Liang TB, Yu ZY, Zheng SS. [Expression of non-T cell derived cytokines in acute rejection after heart transplantation: experiment with mouse model]. Zhonghua Yi Xue Za Zhi. 2006 Jan 3;86(1):26-30. Chinese.

  PMID: 16606531 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: May 9, 2017
• Study Start: April 9, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)