Heart and Blood Diseases

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Coronary Artery Disease

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Systemic Inflammatory Response Syndrome

Coronary Disease

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Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass

Cell saver

Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass

No cell saver

Sune Damgaard, MD

Daniel A Steinbrüchel, Professor

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.

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 ?

Danish Heart Foundation

Copenhagen Hospital Corporation

Rigshospitalet, Denmark

Nutritional and Metabolic Diseases

Obesity

Obesity, Abdominal

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Retinol

The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity.

Endurance training

Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate.

Endurance-strength training

Pawel Bogdanski, Prof.

The aim of this study was to compare the effects of three months' endurance training and three months' endurance-strength training on inflammatory markers in women with abdominal obesity.

Study patients. Written informed consent was obtained from all subjects. The study meets the standards of the Declaration of Helsinki in its revised version of 1975 and its amendments of 1983, 1989, and 1996.

Study design. The study was designed as a prospective randomized trial. Subjects were randomly divided into two groups, A and B, using a randomization list. Both groups performed three month of physical training. Group A underwent endurance training, while group B performed endurance-strength training. Aside from the training, all subjects were instructed to maintain the physical activity and diet that they had been practicing so far. At baseline and after three months of physical training, blood samples for laboratory analyses were taken, anthropometric measurements were performed for both groups.

Intervention. The exercise program lasted three months, with three sessions per week. Women in both groups participated in a total of 36 training sessions. The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity. Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate. Both the endurance and endurance-strength training were comparable in exercise volume; the only difference was the nature of the effort.

The study was designed as a prospective randomized trial.

Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity

Serum concentration of C-reactive protein at baseline

Serum concentration of C-reactive protein after three months of physical training

Serum concentration of tumor necrosis factor alpha at baseline

Serum concentration of tumor necrosis factor alpha after three months of physical training

Serum concentration of soluble receptor 2 of TNF alpha at baseline

Serum concentration of soluble receptor 2 of TNF alpha after three months of physical training

Serum concentration of interleukin 6 at baseline

Serum concentration of interleukin 6 after three months of physical training

Serum concentration of interleukin 1 at baseline

Serum concentration of interleukin 1 after three months of physical training

Serum concentration of visfatin at baseline

Serum concentration of visfatin after three months of physical training

Body mass after three months of physical training

Body height after three months of physical training

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark
Effect of Endurance and Endurance-Strength Training on Inflammatory Markers in Women With Abdominal Obesity	NCT03444207	Obesity	Endurance train... Endurance-stren...	18 Years - 65 Years	Poznan University of Medical Sciences
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for tumor necrosis factor alfa