Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

This study has been terminated.
(For financial and logistical reasons)
Sponsor:
Collaborators:
Danish Heart Foundation
Copenhagen Hospital Corporation
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00159926
First received: September 8, 2005
Last updated: January 4, 2008
Last verified: November 2007

September 8, 2005
January 4, 2008
January 2003
Not Provided
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. ] [ Designated as safety issue: No ]
Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2 and LPS in patient blood: Preoperatively, during CPB before and after aortic crossclamping, after CPB, at the ICU and postoperative day 1 and 3.
Complete list of historical versions of study NCT00159926 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Bleeding
  • Need for allogenic blood transfusions and blood products
  • Clinical effect focusing on known complications to cardiac surgery and CPB
Not Provided
Not Provided
 
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Inflammatory Response Syndrome
  • Coronary Arteriosclerosis
  • Procedure: Cell saver
    Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
  • Procedure: No cell saver
    Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass
  • Experimental: 1
    With cell saver
    Intervention: Procedure: Cell saver
  • Active Comparator: 2
    Without cell saver
    Intervention: Procedure: No cell saver
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
February 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00159926
959583153, 961501172, DHF: 03-2-3-35-22109, CHC: 20/fo03
No
Not Provided
Rigshospitalet, Denmark
  • Danish Heart Foundation
  • Copenhagen Hospital Corporation
Principal Investigator: Sune Damgaard, MD Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Director: Daniel A Steinbrüchel, Professor Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Rigshospitalet, Denmark
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP