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NCT ID: NCT05604846 Recruiting - Death Clinical Trials

Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

PEPS
Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28. P: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. I: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34. C: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily. O: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge. Patient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.

NCT ID: NCT05544799 Recruiting - Clinical trials for Near Death Experience

Case Studies of Patients Who Had Experienced Near Death Experience

Start date: January 3, 2021
Phase:
Study type: Observational [Patient Registry]

An prospective observational study to interview patients who had near death experiences among those who had received intensive care unit intervention during admission in hematology ward.

NCT ID: NCT05541523 Recruiting - Depression, Anxiety Clinical Trials

Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

CBT: cognitive behavioural therapy MBT: mindfulness-based therapy

NCT ID: NCT05539898 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification

PERFECT
Start date: January 13, 2017
Phase: N/A
Study type: Interventional

A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy. Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.

NCT ID: NCT05503771 Recruiting - Sudden Infant Death Clinical Trials

Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

NCT ID: NCT05462938 Recruiting - Clinical trials for Postoperative Delirium

Conscious Sedation for Transcatheter Aortic Valve Implantation

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

Aortic valve stenosis is the heart valve disease with the highest prevalence among the elderly, and may lead to heart failure. Until recently, the only definitive treatment was surgical replacement (SAVR). However, the increased risk associated with the surgical procedure excluded patients with multiple co-morbidities. As the population is aging and more and more patients may present with aortic stenosis, the need of a less invasive approach has emerged. Transcatheter Aortic Valve Replacement (TAVR) offered an alternative therapy for these high risk patients. This new method has seen worldwide acceptance, has been proven very beneficial for these patients, and therefore its indications have been expanded to intermediate risk patients, as well. Until recently, general anesthesia was the primary anesthetic technique for TAVR, but conscious sedation or monitored anesthesia care (MAC) is gaining more and more popularity lately. Our knowledge regarding the comparison between general anesthesia and MAC in TAVR procedures is derived mainly from observational studies and few randomized trials. MAC seems to be associated with less inotropic drug usage, shorter procedural times, shorter intensive care unit (ICU) and hospital length of stay. However, according to published data, there were no differences in 30-day mortality and complications between these two techniques. Even less are known about the most suitable anesthetic agent for MAC during TAVR. Many drugs have been used, with propofol and dexmedetomidine being the most popular. However, there are only few comparative studies and their results are not conclusive. This study compares MAC under propofol and MAC under dexmedetomidine for TAVR in order to examine which method of conscious sedation comes with more beneficial postoperative outcomes for the patients.

NCT ID: NCT05462041 Recruiting - Organ Transplant Clinical Trials

DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.

NCT ID: NCT05454202 Recruiting - Pain Clinical Trials

Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care

ANI-CARE
Start date: September 22, 2022
Phase:
Study type: Observational

Comfort evaluation is one of the major challenges in the palliative care setting, particularly when it comes to non-communicative patients. ANI monitoring is a non-invasive and painless technique which evaluates the parasympathetic tone activity through heart rate variability. It has proven reliable for pain assessment during general anesthesia (GA) or for sedated critically ill patients. The parasympathetic activity seems to be a good reflect of the patient's comfort, implicating stress and anxiety. So, the ANI could be an interesting tool to assess the comfort of non-communicating end-of-life patients. That is why the goal of our study is to assess the interest of ANI to assess the comfort of non-communicating patients hospitalized in palliative care during a painful care by comparing the ANI measure to the CPOT scale realised by the nurses in a blind manner.

NCT ID: NCT05446272 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

DIVA
Start date: August 3, 2022
Phase: N/A
Study type: Interventional

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 24-27 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.

NCT ID: NCT05444348 Recruiting - Multiple Myeloma Clinical Trials

Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)

ACT
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept "Advance Consultations Concerning participants Life and Treatment" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.