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Cardiac Surgery Requiring Cardiopulmonary Bypass clinical trials

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NCT ID: NCT02518087 Completed - Acute Kidney Injury Clinical Trials

Increased Adsorption Membranes During Cardiopulmonary Bypass

Start date: September 2016
Phase: N/A
Study type: Interventional

Our project intends to reduce cardiac surgery associated - acute kidney injury (CSA-AKI) in non emergent patients with the use of an increased adsorption membrane (oXiris®) connected to the cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a randomized and controlled multicentre trial that includes recruiting centres with a long experience in cardiac surgery with CPB. The primary endpoint of the project is to evaluate the ability of oXiris® to reduce the incidence of CSA-AKI in patients undergoing non emergent cardiac surgery with an expected CPB time of more than 90 minutes (doble valve replacement or valve replacement plus coronary artery bypass graft). With the goal of reducing by 10% (from 25 to 15%) the risk of CSA-AKI during the first postoperative week a sample size of 340 patients has been calculated. Secondary endpoints are two; first, to evaluate the effect of using oXiris® on survival, clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and after CPB; and second, to assess the predictive value for CSA-AKI of some new biomarkers, such as uNAD (urinary nicotinamide adenine dinucleotide).

NCT ID: NCT02239146 Completed - Clinical trials for Acquired Bleeding Disorder

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Start date: October 2005
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

NCT ID: NCT02132871 Completed - Clinical trials for Cardiac Surgery With Extracorporeal Circulation

Preload Dependency by Impedance Cardiography After Cardiac Surgery

Start date: May 2014
Phase: N/A
Study type: Observational

The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.

NCT ID: NCT01704482 Completed - Renal Dysfunction Clinical Trials

N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement

Start date: February 2011
Phase: Phase 2
Study type: Interventional

We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.

NCT ID: NCT01562574 Completed - Clinical trials for Acquired Bleeding Disorder

Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

Start date: January 2002
Phase: Phase 3
Study type: Interventional

This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.

NCT ID: NCT01561651 Completed - Atrial Fibrillation Clinical Trials

Left Atrial Appendage Occlusion Study III

LAAOS III
Start date: July 2012
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works. The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.

NCT ID: NCT01153997 Completed - Healthy Clinical Trials

Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

Start date: June 2010
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00914589 Completed - Clinical trials for Acquired Bleeding Disorder

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

Start date: July 2009
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00645008 Completed - Clinical trials for Cardiac Surgery Intensive Care Treatment

Identification of Dominate Stressors in the Intensive Care Unit (ICU)

Start date: April 2008
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00467181 Completed - Clinical trials for Cardiac Surgery With Cardiopulmonary Bypass

A Pilot Study to Investigate Fenoldopam Usage in the Prevention of Postoperative Renal Dysfunction in Patients at a High Risk for Renal Impairment During Cariopulmonary Bypass for Cardiac Surgery

Start date: January 2005
Phase: Phase 2
Study type: Interventional

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.