View clinical trials related to Cardiac Surgery Requiring Cardiopulmonary Bypass.
Filter by:This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery. The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery. Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU. The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
The Primary objective is to reduce the incidence of postoperative renal dysfunction in a high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min, Fenoldopam at 0.1 mcg/kg/min or placebo Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for diuretics, requirements for ECF at discharge, and overall perioperative cost reduction through decreased ICU and hospital length of stay.
Many patients develop kidney failure after cardiac surgery. Although this kidney failure can usually be treated effectively, a longer stay in intensive care is often required. While many patients suffer no long term ill effects after developing post-operative kidney failure, some require long term kidney dialysis. We also know that patients who develop post-operative kidney failure are much more likely to die before they leave hospital. Why some people develop kidney failure after cardiac surgery is not known. However, doctors suspect that the process of cardiopulmonary bypass (where the functions of the heart and lungs are taken over by a machine during the operation, to allow the surgeon to operate) overactivates some of the same mechanisms the body uses to defend itself against severe infection. Many of the cell changes by which severe infection causes kidney failure also occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'. The investigators believe that sodium bicarbonate might reduce the oxidative stress, which occurs during cardiac surgery, and so prevent or decrease the kidney failure, which occurs in many patients. The investigators hope to give sodium bicarbonate (in similar doses to those used safely for treatment of acidosis) to patients during, and for 24 hours after cardiac surgery, and to compare the effects with patients who have not had sodium bicarbonate. The drug, or a placebo, will be given through the drip, which is present in all cardiac surgery patients. Whether a particular patient receives the drug or placebo will be decided at random, and neither the patient nor the investigators will know which has been given. We will measure kidney function before and after the operation using the standard blood tests. The investigators will also take four 20ml samples of blood, spaced before, during, and after the operation, from the arterial catheter routinely inserted in every patient. This blood would be used to measure oxidative stress, and also some of the proteins inside the blood cells, which are responsible for creating the toxic oxygen compounds. In this way we will discover not only the effect of sodium bicarbonate, but also the mechanism of that effect. Sodium bicarbonate is commonly used to treat metabolic acidosis in severe renal disease, circulatory insufficiency due to shock or severe dehydration and has been shown to be an effective drug in preventing contrast-induced nephropathy. Sodium bicarbonate is considered to be safe in the setting of intensive care treatment and is often used in the treatment of patients with metabolic acidosis without any discernible adverse clinical effects. This is a pilot study. If the drug proves effective in this context, further studies on a larger scale would be required to justify its general use. There will be no extra risk to a patient who participates in the study, and no discomfort other than that normally associated with cardiac surgery. Informed consent will be obtained from the patient prior to the operation by one of the investigators or the ICU research nurse. The clinical care of a patient who does not consent for any reason will not be affected.
At least 14% of patients develop kidney failure after cardiac surgery. Although this kidney failure can usually be treated effectively, a longer stay in intensive care is often required. While many patients suffer no long term ill effects after developing post-operative kidney failure, some require long term kidney dialysis. The investigators also know that patients who develop post-operative kidney failure are much more likely to die before they leave hospital. Why some people develop kidney failure after cardiac surgery is not known. However, doctors suspect that the process of cardiopulmonary bypass (where the functions of the heart and lungs are taken over by a machine during the operation, to allow the surgeon to operate) overactivates some of the same mechanisms the body uses to defend itself against severe infection. Many of the cell changes by which severe infection causes kidney failure also occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'. Another well-known cause of oxidative stress is paracetamol (Panadol) overdose. In large doses the oxidative stress caused by paracetamol damages cells in the liver, where it is digested, and the kidney. N-acetylcysteine is a drug in common use for the treatment of paracetamol overdose. Patients who would otherwise die of liver failure are routinely saved by N-acetylcysteine, which acts as a strong anti-oxidant. The investigators believe that N-acetylcysteine might similarly reduce the oxidative stress which occurs during cardiac surgery, and so prevent or decrease the kidney failure which occurs in many patients. The investigators hope to give N-acetylcysteine (in similar doses to those used safely for paracetamol poisoning) to patients during, and for a day after cardiac surgery, and compare the effects with patients who have not had N-acetylcysteine. The drug, or a 5% glucose placebo, will be given through the drip which is present in all cardiac surgery patients. Whether a particular patient receives the drug or placebo will be decided at random, and neither the patient nor the investigators will know which has been given. The investigators will measure kidney function before and after the operation using the standard tests which are performed for the purposes of clinical care of every patient. Also, the investigators will do an extra test involving the collection of urine (from the urinary catheter every patient has after cardiac surgery), which provides an even better measure of kidney function. This is a potential benefit to the patient, as while this test is not routinely performed, the results will be available to the doctors in the intensive care unit. The investigators will also take four 20ml samples of blood, spaced before, during, and after the operation, from the arterial catheter routinely inserted in every patient. This is an insignificant amount of blood compared to that taken for other tests, and would have no adverse effects. This blood would be used to measure oxidative stress, and also some of the proteins inside the blood cells which are responsible for creating the toxic oxygen compounds. In this way the investigators will discover not only the effect of N-acetylcysteine, but the mechanism of that effect. N-acetylcysteine is routinely used to treat paracetamol overdose with few side effects. An itchy skin rash is the only common side effect. Sometimes patients develop nausea and vomiting, but the treatment for this is usually very effective, and the drug will be stopped if it occurs. Rarely, as with all drugs, allergic reactions have been reported, but there are no other reported adverse effects. There will be no extra risk to a patient who participates in the study, and no discomfort other than that normally associated with cardiac surgery. The itchy rash which occasionally develops with N-acetylcysteine would occur under anaesthetic, and would almost certainly be gone by the time the patient wakes up. Informed consent will be obtained from the patient prior to the operation by one of the investigators or the ICU research nurse.
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.