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Cardiac Surgery clinical trials

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NCT ID: NCT00395369 Not yet recruiting - Cardiac Surgery Clinical Trials

Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.

Start date: December 2007
Phase: N/A
Study type: Interventional

Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common and multi-factorial in origin. Several previous studies have shown that intraoperative aprotinin administration may be neuroprotective.in the current prospective randomized study, the effect of intraoperative aprotinin administration on the integrity of the optic nerve and retinal nerve fiber layer will be examined. Optical coherance tomography will be used to examin the optic nerve and retinal nerve fiber layer.

NCT ID: NCT00338234 Completed - Anemia Clinical Trials

Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients

FAIRe
Start date: June 2006
Phase: N/A
Study type: Observational

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

NCT ID: NCT00337805 Completed - Cardiac Surgery Clinical Trials

Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery

Start date: September 2004
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.

NCT ID: NCT00336466 Completed - Cardiac Surgery Clinical Trials

The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

Start date: September 2004
Phase: Phase 2
Study type: Interventional

Context: Neurocognitive dysfunction complicates coronary artery bypass graft surgery. Neurocognitive dysfunction is a measurable problem with thinking. Erythropoietin may be a neuroprotectant. Objective: To investigate the feasibility and safety of three doses of human recombinant erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients.

NCT ID: NCT00334009 Completed - Cardiac Surgery Clinical Trials

Catecholamine-O-Methyl-Transferase(COMT)-Polymorphism in Cardiac Surgery

Start date: June 2006
Phase: N/A
Study type: Observational

Although clinical risk factors for postoperative development of vasodilatory shock and acute renal failure have been identified; there is a considerable proportion of patients undergoing cardiac surgery where this syndrome cannot be predicted. We sought to investigate the impact of Catecholamine-O-Methyltransferase (COMT) polymorphism on the duration of vasodilatory shock and other important clinical outcomes in cardiac surgery patients. COMT is a key enzyme in the degradation of catechols eg. catecholamines. 25% of the population have a low activity (L/L) of this enzyme. Sustained low COMT activity is associated with an altered metabolic profile of catecholamines and their degradation products. The process of cardiopulmonary bypass (CPB)over-activates some of the same mechanisms the body uses to defend itself against severe infection. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative-stress'. Increased reactive oxygen species (ROS) generation can lead to inactivation of biologic mediators, including catecholamines. It is well established that some radicals autoxidizes catecholamines, including DA, NE, and epinephrine and contribute significantly to vasoplegia. As part of this study, we will take six 2.7mL samples of blood, collected before, and after the operation, from the arterial catheter routinely inserted in every patient. This blood will be used to measure COMT genotype, the concentration of plasma-catecholamines as well as marker of oxidative stress. Our plan is to enrol patients undergoing cardiac surgery if the use of the CPB is planned.

NCT ID: NCT00247793 Completed - Cardiac Surgery Clinical Trials

Immunonutrition in Cardiac Surgery

Start date: July 1996
Phase: N/A
Study type: Interventional

Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high risk of infection after cardiac surgery: a randomized placebo-controlled study. Introduction: In our first study we showed that the use of a preoperative oral immune-enhancing nutritional supplement (OIENS) resulted in an improved patients’ host-defence with a reduction in postoperative infectious morbidity in ‘high-risk’ cardiac surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction. Experimental studies have shown that additional glycine results in less ischemia-reperfusion damage and that glycine has anti-inflammatory properties. Objective: The use of an OIENS in the preoperative period in patients at high risk of infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results in a reduction in infections as in our first study. The addition of 9.6 gram glycine per sachet OIENS results in a further reduction in postoperative dysfunction. Design: A prospective randomized placebo controlled study with two oral immune enhancing nutritional formula’s and an isocaloric control formula. Patients: Seventy-four consecutive patients undergoing cardiac surgery with the use of an CPB who met one or more of the following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy, use of corticosteroids, severe renal and liver failure. Definition of a protocol violation was the intake of less then 5 L or more then 10 L of the nutritional supplement in the preoperative period. Intervention: Patients were split up in three groups by concealed randomisation. One group received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group received the OIENS further enriched with glycine (OIENS+glyc). The control group received an isocaloric nutritional supplement without the enrichments.

NCT ID: NCT00229892 Terminated - Cardiac Surgery Clinical Trials

Incisions for Cardiac Surgery

Start date: February 2005
Phase: N/A
Study type: Observational

The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.

NCT ID: NCT00208728 Completed - Cardiac Surgery Clinical Trials

Cardiopulmonary Circuits in the Pediatric Population

Start date: May 2003
Phase: N/A
Study type: Interventional

During open-heart surgery, blood flow is supported by a heart-lung machine that both pumps the blood and gives it oxygen. A problem associated with a heart-lung machine is the damage to some of the blood caused by protein in the blood cell sticking to the sides of the heart-lung machine tubing. This breakdown of the blood cell affects the platelets, which help the blood to clot. Use of the un-treated circuit will be phased out within the next few years, as newer technology is available. The use of coated tubing has been shown to decrease problems with post-operative bleeding in the adult population. No studies have been done on the pediatric population. We plan to perform a prospective, randomized study using the un-treated circuits used now, the " Smart" circuit tubing manufactured by Cobe Cardiovascular Inc., Arvada, CO and the PMEA circuit manufactured by Terumo Corporation, Tokyo, Japan. Randomization will be performed by the perfusionist (the person that runs the heart-lung machine) in charge of the case. No one else will be aware of which circuit is being used. There will be no changes in the operation of the heart-lung machine, anesthesia or the surgery because of this study. Blood testing that is standard of care and some additional tests will be performed on a small amount of blood drawn from. the patient via arterial lines. Additional blood sticks will not be required to obtain this sample.

NCT ID: NCT00182377 Recruiting - Cardiac Surgery Clinical Trials

Pentastarch Use in Cardiac Surgery

Start date: n/a
Phase: N/A
Study type: Interventional

Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?

NCT ID: NCT00073593 Completed - Cardiac Surgery Clinical Trials

Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

OPCAB
Start date: August 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.