Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159926
Status:
TERMINATED
Last Update Posted:
2008-01-14
First Post:
2005-09-08
Brief Title:
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For financial and logistical reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n20 in the trial group use of cell saver and n20 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
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 n20 in the trial group use of cell saver and n20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHC 20fo03 | None | None | None |
| 961501172 | None | None | None |
| DHF 03-2-3-35-22109 | None | None | None |