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Cardiac Output, Low clinical trials

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NCT ID: NCT04643509 Recruiting - Surgery Clinical Trials

Validity of Cardiac Output Measurement Using Niccomo Device After Cardiac Surgery

Niccomo-Card
Start date: December 18, 2020
Phase:
Study type: Observational

Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications. Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.

NCT ID: NCT04405856 Recruiting - Clinical trials for Coronary Artery Disease

Outcome of Patients Treated With IABP

Start date: February 1, 2012
Phase:
Study type: Observational

Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.

NCT ID: NCT04191408 Recruiting - Surgery Clinical Trials

Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

NCT ID: NCT04179604 Recruiting - Cardiac Output, Low Clinical Trials

Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)

SPARTANS
Start date: June 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Low cardiac output Syndrome (LCOS) is a complication that appears in approximately 20% of cardiac surgeries with extracorporeal circulation. LCOS is associated with increased mortality, delayed recovery and prolonged hospital stay. The Spanish Randomized Clinical Trial on Levosimendan (brand name: Sindax) (SPARTANS) aims to demonstrate the effectiveness of the preoperative use of Levosimendan in reducing LCOS in patients with poor left ventricle ejection fraction (LVEF) undergoing elective cardiac surgery. SPARTANS study is a multicenter, randomized triple-blind, placebo-controlled trial. 300 patients with LVEF ≤ 35%, undergoing elective cardiac surgery will be recruited from 9 Spanish hospitals and randomized into two groups: Preoperative administration of levosimendan or placebo for 24 hours. The study drug will be started as a continuous infusion (0.1 µg/kg/min) at least 8 hours before surgery to complete 24h duration. The primary endpoint will be 30-day LCOS. It will be evaluated using any of the following criteria: 1) postoperated cardiac index ≤2.0 L / min / m2, 2) a need to implant a intra-aortic balloon pump/ left ventricular assist device, 3) a vasoactive inotropic scale (VIS) > 5.5. The secondary end-point will be composite event rate at one year including any of the following events: death from any cause, need for renal replacement therapy or dialysis and LCOS. The sample size is based on the assumption that levosimendan reduces LCOS by 50% being necessary a sample size of 300 patients to carry out the study. The Research Team of each hospital, will carry out the clinical follow-up by telephone or clinical interview of the patient according to the time intervals: 30 days and 1 year. We estimate that the total sample size of 300 patients will be reached in 2-2.5 years. In conclusion, the effectiveness of levosimendan has not yet been reported with a good evidence in cardiac surgery. The purpose of the "Spanish Randomized Clinical Trial on Sindax" (SPARTANS) trial is to evaluate the beneficial effect of preoperative use of levosimendan compared with placebo to reduce perioperative LCOS in patients undergoing cardiac surgery with poor LVEF ≤ 35%.

NCT ID: NCT04064177 Recruiting - Blood Pressure Clinical Trials

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

NICCOM
Start date: October 24, 2019
Phase:
Study type: Observational

This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.

NCT ID: NCT03823781 Recruiting - Clinical trials for Cardiac Surgical Procedures

Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Start date: February 2019
Phase: Phase 3
Study type: Interventional

This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.

NCT ID: NCT03558269 Recruiting - Clinical trials for Congenital Heart Disease

Autologous Umbilical Cord Blood Treatment of Neonate With CHD

Start date: February 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

NCT ID: NCT02728791 Recruiting - Shock Clinical Trials

Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution

CONDUCT
Start date: May 10, 2016
Phase: N/A
Study type: Observational

Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

NCT ID: NCT01157299 Recruiting - Sepsis Clinical Trials

Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO

PreloaDren
Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is - To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI, GEF) and lung water indices (ELWI), as predictors of fluid responsiveness in both spontaneously breathing and mechanically ventilated pediatric patients. - To assess the value of stroke volume and pulse pressure changes from femoral pulse contour analysis (PiCCO2) during passive leg raising as predictor of fluid responsiveness in pediatric patients. - To establish normal and cutoff values of transpulmonary thermodilution (PiCCO2) hemodynamic variables in hemodynamically stables and hemodynamically "normal" patients.

NCT ID: NCT00989508 Recruiting - Cardiac Output, Low Clinical Trials

Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

HYPER
Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.