Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
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|ClinicalTrials.gov Identifier: NCT00159926|
Recruitment Status : Terminated (For financial and logistical reasons)
First Posted : September 12, 2005
Last Update Posted : January 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammatory Response Syndrome Coronary Arteriosclerosis||Procedure: Cell saver Procedure: No cell saver||Phase 3|
Hide Detailed Description
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.
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.
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||February 2004|
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
- 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. ]
- 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 ]
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
|Department of Cardiothoracic Surgery, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Sune Damgaard, MD||Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen|
|Study Director:||Daniel A Steinbrüchel, Professor||Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen|