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Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

This study has been terminated.
(For financial and logistical reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159926
First Posted: September 12, 2005
Last Update Posted: January 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Danish Heart Foundation
Copenhagen Hospital Corporation
Information provided by:
Rigshospitalet, Denmark
  Purpose
Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body. This leads in few percent of cases to heart, lung, and kidney disturbances that potentially causes death. White blood cells in contact with the heart and lung machine and external surfaces release mediators partly responsible for this. Blood collected by the suction and the blood remaining in the heart and lung machine after its use, can be cleaned by a cell saver before reinfusion, and this might reduce the inflammatory response.

Condition Intervention Phase
Systemic Inflammatory Response Syndrome Coronary Arteriosclerosis Procedure: Cell saver Procedure: No cell saver Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood. [ Time Frame: 6, 24 and 72 hours after termination of CPB. ]

Secondary Outcome Measures:
  • Bleeding [ Time Frame: Intra- and postoperatively ]
  • Need for allogenic blood transfusions and blood products [ Time Frame: Within submission ]
  • Clinical effect focusing on known complications to cardiac surgery and CPB [ Time Frame: Within submission ]

Enrollment: 30
Study Start Date: January 2003
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: 1
With cell saver
Procedure: Cell saver
Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
Active Comparator: 2
Without cell saver
Procedure: No cell saver
Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass

  Hide Detailed Description

Detailed Description:

Introduction

Cardiopulmonary bypass (CPB) during cardiac surgery induces in all patients a systemic inflammatory response syndrome (SIRS) that is more pronounced than for other surgical procedures. Depending on the severity of this, myocardial dysfunction, respiratory failure, renal and neurological dysfunction, coagulation disturbances and impaired liver function might follow. In worst cases this leads to acute respiratory distress syndrome, disseminated intravascular coagulation, multi organ failure, shock and death. The cause is besides the surgical trauma, the passage of the blood through the extra corporal circulation (ECC) and its pumps and oxygenator, hemodilution, hypothermia, heparin and protamine administration, ischemia and reperfusion, and endotoxemia (LPS) as a cause of intestinal ischemia. The ECC is the main cause of immunological activation and leads in severe cases to the so-called post-perfusion syndrome. This is characterised by increased capillary permeability and intercellular fluid, peripheral vasoconstriction, fever, myocardial edema, diffuse cerebral edema and diffuse hemorrhagic diathesis. This syndrome is considered to be a more severe form of SIRS. Even though most patients have no sequelae after CPB, all patients must be considered to be influenced, in varying degree, by SIRS. High levels of pro-inflammatory cytokines (interleukin (IL)-6, IL-8, IL-1a, IL-1b, tumor necrosis factor (TNF) alfa), have generally been associated with adverse events after CPB. Of importance is also LPS from gram-negative intestinal bacteria, translocating to the systemic circulation during ischemia.

Hypothesis

Cleansing of suction blood and the remaining blood in the ECC after termination of CPB, reduces the load of inflammatory cells and mediators in the patients' circulation. This potentially diminishes SIRS with a reduction in postoperative organ dysfunction and morbidity.

Aim

To cleanse suction blood and the remaining blood in the ECC after termination of CPB by means of a cell saver and monitor the influence on inflammatory mediators and the potential clinical benefits.

Outcome measures

Primary: Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood: 6, 24 and 72 hours after termination of CPB.

Secondary: Bleeding, need for allogenic blood transfusions and blood products and clinical effect focusing on known complications to cardiac surgery and CPB.

Design

Prospective randomised clinical trial including 40 patients planned for on-pump coronary artery bypass grafting (CABG). n=20 in the trial group (use of cell saver) and n=20 in the control group (no cell saver). No patients receive postoperative autotransfusion of drain blood.

Sample size

Estimation based on comparable studies.

Anaesthesia and surgery

In accordance with current guidelines of the clinic, this includes prophylactic antibiotics (cefuroxime and gentamycin). Cell saver: Medtronic Autolog.

Patient exclusion during the trial

Patients are excluded in cases of autotransfusion of blood not cleansed by the cell saver, for instance in cases of major blood loss.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Oral and written informed consent.
  • No limits regarding age or ejection fraction.

Exclusion Criteria:

  • Off-pump coronary artery bypass grafting
  • Redo CABG
  • Current infection
  • Antibiotic treatment
  • S-creatinin > 200 micromol/L
  • Antiinflammatory / immuno-modulating treatment: Steroids, immunosuppressive or -stimulating agents (NSAIDs and ASA allowed)
  • Liver disease
  • Immune disease
  Contacts and Locations
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): NCT00159926


Locations
Denmark
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Heart Foundation
Copenhagen Hospital Corporation
Investigators
Principal Investigator: Sune Damgaard, MD Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Director: Daniel A Steinbrüchel, Professor Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
  More Information

ClinicalTrials.gov Identifier: NCT00159926     History of Changes
Other Study ID Numbers: 959583153
961501172
DHF: 03-2-3-35-22109
CHC: 20/fo03
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: January 14, 2008
Last Verified: November 2007

Keywords provided by Rigshospitalet, Denmark:
systemic inflammatory response syndrome
coronary artery bypass grafting
cell saver
interleukins
tumor necrosis factor alfa

Additional relevant MeSH terms:
Arteriosclerosis
Systemic Inflammatory Response Syndrome
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Inflammation
Pathologic Processes
Shock
Coronary Disease
Heart Diseases