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Cardiac Surgery clinical trials

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NCT ID: NCT01470976 Completed - Cardiac Surgery Clinical Trials

Goal-directed Resuscitation in High-risk Patients Undergoing Cardiac Surgery

GRICS
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The primary aim of the study is to investigate whether a goal-directed resuscitation therapy in high-risk patients through cardiac index optimization using the LiDCO Rapid device reduces complications after cardiac surgery. The hypothesis is that there are better outcomes when achieving a cardiac index higher than 3L/min/m2 in those patients with an arterial lactate higher than 1.5 mmol/L.

NCT ID: NCT01398436 Completed - Cardiac Surgery Clinical Trials

Hemoglobin Saturation in Superior Vena Cava and Right Atrium

Start date: March 2011
Phase: N/A
Study type: Interventional

The aim of the study is to compare oxygen saturation of blood samples collected from the superior vena cava, the right atrium, and the pulmonary artery. A secondary target was to assess whether positioning the tip of central venous catheters in the right atrium causes more arrhythmias than positioning it in the superior vena cava. The study is carried out in patients that undergo central venous and pulmonary artery catheterization for surgical coronary revascularization. In the interventional group (atrium, A), the tip of the central venous catheter (CVC) is placed in the right atrium; in the control group (control, C), the tip is placed in the superior vena cava. In both groups, CVC position is confirmed with transesophageal echocardiography (TEE). At fixed times during surgery and in the following 72 hours, heparinized blood samples are collected from the proximal and distal CVC lumens and from the distal lumen of the pulmonary catheter (PC) and oxygen saturation is measured by an oximeter. Besides, mechanical and electrical complications potentially influenced by CVC position are registered. 1. The primary aim of the study will be achieved by performing the following analysis on values from CVC proximal and distal lumens: 1. a Bland Altman analysis between proximal and distal oxygen saturation in group A, in order to evaluate if the two measures are equivalent 2. a comparison of the difference between proximal and distal oxygen saturation in groups A and C in order to rule out random errors 2. In addition: 1. differences in oxygen saturation between proximal or distal CVC and distal PC will be compared in order to evaluate whether distal saturation is more indicative of mixed venous saturation 2. differences between proximal and distal oxygen saturation will be correlated with cardiac index and PCWP to investigate if low cardiac output and hypovolemia increase differences 3. The secondary aim of the study will be achieved by comparing the incidence of cardiac arrhythmias in groups A and C

NCT ID: NCT01356082 Completed - Cardiac Surgery Clinical Trials

CNAP™ Monitor Study

Start date: May 2011
Phase: N/A
Study type: Observational

A newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) provides beat-to-beat BP readings and is non-invasive. To make sure that anaesthesiologist can rely on and make clinical decisions based on values provided by the CNAP™ monitor, to demonstrate its reliability we will test it during the perioperative care of children.

NCT ID: NCT01274390 Completed - Cardiac Surgery Clinical Trials

Impact of Blood Storage Duration on Physiologic Measures

RECAP
Start date: January 2011
Phase: N/A
Study type: Observational

This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units stored for at least 21 days, if they need any red blood cell transfusions during their hospital stay for the surgery. This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there will be differences between the two randomized treatment groups in how much the following measurements change, from shortly before a red blood cell transfusion to shortly after a red blood cell transfusion, and from before surgery to 24 hours after surgery: - Oxygen saturation in the hand - Oxygen saturation in the brain - Blood flow in the small blood vessels under the tongue. The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including - The Multi-Organ Dysfunction Score - Death from any cause - Major cardiac events - Major pulmonary events

NCT ID: NCT01267487 Completed - Cardiac Surgery Clinical Trials

Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass

Start date: July 2009
Phase: Phase 4
Study type: Interventional

There are currently several schemes described for anticoagulation with heparin and its reversal with protamine during cardiac surgery with CPB. The oldest, and most used in our routine environment, is the scheme of fixed doses, in which a bolus dose of heparin at the start of CPB is established in IU/kg of body weight and the dose of protamine at the end of CPB is calculated based on the initial dose of heparin administered. These schemes do not take into account the variability inter-patients and can result in overdose or sub-doses of one or both drugs. The titration schedule of doses of heparin and protamine through the principle of dose-response curve of Bull promotes individualization of dosage according to the response of each patient. This scheme has been associated with an effective reversal of the effect of heparin after CPB and with reduction of post-operatory bleeding and transfusion. The restoration of a state of anticoagulation by heparin after its reversal by protamine is called "rebound effect". It is a phenomenon explained by the recirculation of heparin stored in the reticulum-endothelial system and connective tissue, or by free residual concentration of heparin after clearance of protamine. This effect may be present for more than 6 hours of post-operatory and may contribute to increase post-operatory bleeding.

NCT ID: NCT01256372 Completed - Cardiac Surgery Clinical Trials

An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery

Start date: October 2010
Phase: Phase 2
Study type: Interventional

This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.

NCT ID: NCT01247051 Completed - Cardiac Surgery Clinical Trials

Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids

Start date: January 2011
Phase: N/A
Study type: Interventional

The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms. Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.

NCT ID: NCT01246947 Completed - Cardiac Surgery Clinical Trials

Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

Start date: September 2010
Phase: N/A
Study type: Interventional

The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.

NCT ID: NCT01228825 Completed - Cardiac Surgery Clinical Trials

Pharmacokinetics of Cefuroxime in Cardiac Surgery With Cardiopulmonary Bypass

Start date: May 2007
Phase: N/A
Study type: Observational

Infection, especially mediastinitis, is major complication in cardiac surgery. Considering that cardiopulmonary bypass (CPB) can alter kinetics of drugs, including antibiotics, the aim of this study was to evaluate the influence of cardiopulmonary bypass ( CPB) on plasma concentrations and pharmacokinetics of cefuroxime, administered prophylactically, in a 1.5g dose, followed by three bolus of 750mg every 6 hours, for 24 hours, in 19 patients undergoing coronary artery bypass graft (CABG) with CPB (CPB Group, n = 10), or without CPB (Off-Pump Group, n = 9); and assess whether the proposed dosing regimen is adequate to maintain plasma concentrations above 16 g/L (4 times the MIC) for the first 24 hours after the beginning of surgery.

NCT ID: NCT01198938 Completed - Cardiac Surgery Clinical Trials

Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery

Start date: August 2010
Phase: N/A
Study type: Interventional

The investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302 patients older than 60, undergoing elective vascular surgery will be randomly divided into 2 groups: treatment and control. During the first 5 postoperative days patients will receive sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for the signs of delirium, quality of sleep and severity of pain daily for the first postoperative week. Screening of delirium will be performed by the specially trained research assistant and based on the Confusion Assessment Method and the validated chart review. Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be compared between the groups.