Trial Information

Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative 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.