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Cardiac Surgery clinical trials

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NCT ID: NCT03859102 Recruiting - Clinical trials for Coronary Artery Disease

Enhanced Recovery After Cardiac Surgery

ERAS
Start date: December 17, 2018
Phase: N/A
Study type: Interventional

Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

NCT ID: NCT03772990 Recruiting - Cardiac Surgery Clinical Trials

Calcium Administration in Cardiac Surgery

ICARUS
Start date: January 14, 2019
Phase: Phase 4
Study type: Interventional

Termination of cardiopulmonary bypass is a critical step in any cardiac surgical procedure and requires a thorough planning. Debate about rationale of calcium administration during weaning of cardiopulmonary bypass has been conducted for several decades; however, a consensus has not been yet reached. Perioperative hypocalcemia can develop because of haemodilution or calcium binding from heparin, albumin and citrate. Perioperative hypocalcemia is often complicated by development of arrhythmias, especially QT interval prolongation. Furthermore, low content of calcium can lead to vascular tone disorders, violation of neuromuscular transmission, altered hemostasis and heart failure, resistant to inotropic agents, especially in patients with concomitant cardiomyopathy. On the other hand, hypercalcaemia is a dangerous complication in cardiac surgery. Among the fatal, but rather rare complications, there are acute pancreatitis and the phenomenon of the "stone heart", which is essentially a reperfusion injury of the myocardium caused by rapid calcium overload. Hypercalcaemia can also trigger rhythm disturbances, hypertension, increase systemic vascular resistance, reduce diastolic compliance and impair relaxation of the myocardium due to excessive calcium intake into the cardiomyocytes, cause coronary vasospasm and aggravate ischaemic myocardial damage, impair arterial graft blood flow during aortocoronary and mammary coronary bypass surgery. To date, there is a lack of data indicating clinical efficacy of calcium administration before separation from CPB. Therefore, we designed this randomized controlled trial to test the hypothesis whether calcium administration at termination of CPB will reduce the need for inotropic support at the end of surgery.

NCT ID: NCT03722979 Recruiting - Cardiac Surgery Clinical Trials

Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

STRECH
Start date: August 9, 2018
Phase: N/A
Study type: Interventional

The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans . For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.

NCT ID: NCT03608956 Recruiting - Acute Kidney Injury Clinical Trials

Renal Oxygen Saturation and Its Association With Acute Renal Injury

Start date: May 1, 2018
Phase:
Study type: Observational

Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. Although several intra-operative strategies are proposed for better outcomes, no effective and fast resulting test is available to be done in operating rooms to assess renal functions. Urine and blood markers as serum creatinine, urine output, fractional excretion of sodium and urea are used for early diagnosis of acute renal injury. Near infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.

NCT ID: NCT03557047 Recruiting - Acute Kidney Injury Clinical Trials

Perioperative Mechanism of Acute Kidney Injury in Cardiovascular Surgery

Start date: March 8, 2018
Phase:
Study type: Observational [Patient Registry]

Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators,and to select the research route from the clinical actual test results .

NCT ID: NCT03551548 Recruiting - Atrial Fibrillation Clinical Trials

Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.

ALDOCURE
Start date: February 26, 2019
Phase: Phase 3
Study type: Interventional

Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral surgery. Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay). Primary objective: To establish whether pre-operative administration of spironolactone leads to a reduction in POAF incidence occurring from randomization and within 5 days after surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR without heart failure. Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective study.

NCT ID: NCT03517189 Recruiting - Cardiac Surgery Clinical Trials

Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the recommended technique for treatment of patients with high-risk of neurological damage or stroke. However, the displacement of the heart to achieve suitable exposure for graft construction elicits hemodynamic changes, potentially requiring conversion to on-pump. Objective: The aim of this study is to evaluate the sequential changes of hemodynamic parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences) system will be used to continuously record heart rate (HR), mean arterial pressure (DBP), central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be evaluated 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate will also be evaluated.

NCT ID: NCT03485833 Recruiting - Cardiac Surgery Clinical Trials

End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness

EEOFR
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

NCT ID: NCT03412448 Recruiting - Chronic Pain Clinical Trials

The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac Surgery

Doul-Card
Start date: June 1, 2017
Phase: N/A
Study type: Observational

The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.

NCT ID: NCT03397784 Recruiting - Cardiac Surgery Clinical Trials

IVC Variation After VT Challenge to Predict Fluid Responsiveness

Start date: February 3, 2018
Phase: N/A
Study type: Observational

The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.