Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
Primary Purpose
Systemic Inflammatory Response Syndrome, Coronary Arteriosclerosis
Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Cell saver
No cell saver
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring systemic inflammatory response syndrome, coronary artery bypass grafting, cell saver, interleukins, tumor necrosis factor alfa
Eligibility 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
Sites / Locations
- Department of Cardiothoracic Surgery, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
With cell saver
Without cell saver
Outcomes
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.
Secondary Outcome Measures
Bleeding
Need for allogenic blood transfusions and blood products
Clinical effect focusing on known complications to cardiac surgery and CPB
Full Information
NCT ID
NCT00159926
First Posted
September 8, 2005
Last Updated
January 4, 2008
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Heart Foundation, Copenhagen Hospital Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00159926
Brief Title
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
Official Title
Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
For financial and logistical reasons
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Heart Foundation, Copenhagen Hospital Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Coronary Arteriosclerosis
Keywords
systemic inflammatory response syndrome, coronary artery bypass grafting, cell saver, interleukins, tumor necrosis factor alfa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
With cell saver
Arm Title
2
Arm Type
Active Comparator
Arm Description
Without cell saver
Intervention Type
Procedure
Intervention Name(s)
Cell saver
Intervention Description
Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
Intervention Type
Procedure
Intervention Name(s)
No cell saver
Intervention Description
Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Bleeding
Time Frame
Intra- and postoperatively
Title
Need for allogenic blood transfusions and blood products
Time Frame
Within submission
Title
Clinical effect focusing on known complications to cardiac surgery and CPB
Time Frame
Within submission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sune Damgaard, MD
Organizational Affiliation
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel A Steinbrüchel, Professor
Organizational Affiliation
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
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