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Cardiac Surgery clinical trials

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NCT ID: NCT03709264 Active, not recruiting - Cardiac Surgery Clinical Trials

Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery.

PROTection
Start date: October 7, 2019
Phase: Phase 3
Study type: Interventional

To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention. The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.

NCT ID: NCT03646565 Completed - Cardiac Surgery Clinical Trials

Psychosocial Development of Children Undergoing Open Cardiac Surgery

Start date: November 20, 2018
Phase:
Study type: Observational

In recent years, improvement of medical treatments leads to the effect, that 90% of children originally born with congenital heart disease (CHD) are reaching adulthood. Mortality rates have significantly decreased in the last decades. However several studies have shown that with multiple consequences have to face the survivors. Eg. neuronal and psychological injuries during the perioperative period. After all, the surgical interventions that save their lives might result in psychological and behavioral deviations and increased morbidity, which is strongly worsening the quality of life, learning abilities and behavioral development of these patients. Not yet available any clinical guidelines for managing or screening these patients for designing intervention, taking corrective actions. The investigators wish to identify those perioperative factors that might affect the well-being, coping, the behavior alteration and psychosocial status of children, who underwent open chest cardiac interventions in early ages. The investigators also wish to understand the long-term changes of the illness-representation of this population and to see its effect for the wellbeing and coping.

NCT ID: NCT03624595 Active, not recruiting - Delirium Clinical Trials

Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

Start date: April 16, 2019
Phase: N/A
Study type: Interventional

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.

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: NCT03601364 Completed - Oxidative Stress Clinical Trials

The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery

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

Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this condition have been described as being related to several events that occur during the cardiopulmonary bypass (CPBS), where blood is exposed to non-physiological surfaces, surgical trauma, ischemia-reperfusion, and changes in body temperature.In addition, CPB induces atelectasis and affects the structure of the bronchoalveolar tree.Prolongation of atelectasis may facilitate proinflammatory cytokine production by macrophages.One of the most damaging consequences of all these events is the formation of reactive oxygen species (ROS) and radicals originating from various cellular and enzymatic sources such as myocardial cells, activated neutrophils.ROS has toxic effects on cellular structures including lipids, proteins and nucleic acids.Oxidative reaction damages cellular function and may increase perioperative or postoperative complications after CPBS.Total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) reflect the redox balance between oxidation and antioxidation.TAS measurement is an indication of the activity of all antioxidants and TOS is an indicator of ROS.OSI is a measure of the ratio of TOS to TAS and the level of Oxidative Stress (OS).The contribution of various mechanisms to oxidant-antioxidant balance during on-pump coronary artery bypass grafting (ONCABG) has not yet been fully evaluated. The investigator's aim in this study is to investigate the effect of lung protective mechanism (Tidal Volum, PEEP) on oxidative stress parameters such as TAS, TOS, Thiol / Disulphide, Catalase, Glutathione Peroxidase, MDA (Melanil Dialdehyde) in cardio pulmonary bypass surgery

NCT ID: NCT03563196 Completed - Cardiac Surgery Clinical Trials

Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children

Start date: September 2016
Phase:
Study type: Observational

Pulmonary complications are frequent in cardiac surgery, representing an important cause of morbidity, prolongation of hospital stay and need for repeated examinations.Chest X-rays are done routinely and even multiple times to detect such complications.Lung ultrasonography is an alternative test to detect pulmonary complications that can be done easily on bedside. Regularly done Chest X-ray exposes patient to ionizing radiation which can be reduced with ultrasonography. Lung ultrasound is gaining popularity in recent years as a non-invasive,radiation-free tool for the diagnosis of various acute and chronic pulmonary diseases due to its bedside convenience, accuracy, and free of radiation.There is increasing evidence to support the use of Lung ultrasound in acute care setting and post-cardiac surgical patients are also considered critically ill. The purpose of this study is to compare diagnostic performance of lung ultrasound in comparison to chest X-ray to detect pulmonary complication after cardiac surgery in children.

NCT ID: NCT03558984 Terminated - Cardiac Surgery Clinical Trials

D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery

Start date: December 17, 2019
Phase: Phase 3
Study type: Interventional

Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.

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: NCT03552887 Completed - Cardiac Surgery Clinical Trials

Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery

Adephysio
Start date: June 1, 2016
Phase:
Study type: Observational

This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. This is a prospective cohort study, and the investigators observed all types of physiotherapy interventions in patients admitted at surgical ICU.

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.