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Critical Illness clinical trials

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NCT ID: NCT05339737 Not yet recruiting - Critical Illness Clinical Trials

The Nociception Level (NOL) Index for Pain Assessment in the Adult Intensive Care Unit

NOL-ICU
Start date: May 1, 2022
Phase:
Study type: Observational

Assessing pain in the adult intensive care unit (ICU) is challenging because many patients are unable to communicate due to mechanical ventilation and sedation. Therefore, it is necessary to have alternative methods to assess pain in this vulnerable patient population. In this project, the use of a multi-parameter technology (i.e., the Nociception Level (NOL) index) will be tested for pain assessment in ICU adults. The NOL index is a value from 0 to 100 obtained by calculating different parameters (e.g., pulse, skin temperature) captured through a small probe placed on the patient's finger. The NOL was initially developed for assessing nociception, pain and analgesia in anesthetized patients undergoing surgery, and its use in the ICU is new. The NOL's use before, during and after standard care procedures known to be painful (e.g., tube or drain removal, suctioning of secretions through the endotracheal tube) and non-painful (e.g., cuff inflation to measure blood pressure, soft touch) in ICU adults. The NOL will be monitored in three groups: a) patients able to communicate so they can self-report their pain (gold standard criterion) and express behaviors, b) patients unable to communicate but express behaviors (reference criterion), and c) patients unable to communicate and to express behaviors. In the first group, patients will be asked to self-report their pain and procedural distress on a 0 to 10 scale. In the first and second group, patients will be assessed for pain using a standardized behavioral scale which will be completed by trained research staff. In the third group, only the NOL will be monitored. Analgesic and sedative medication administered to patients will also be documented from medical charts. The ability of the NOL to detect pain based on self-reports of pain and behavioral scores, and its ability to discriminate between painful and non-painful procedures will be examined. If found to be useful, the NOL could be used as an alternative measure of pain and improve its recognition and treatment in vulnerable ICU patients.

NCT ID: NCT05331742 Not yet recruiting - Critical Illness Clinical Trials

Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in Critical Care Unit.

Start date: April 15, 2022
Phase:
Study type: Observational

Corona virus disease has been a pandemic since its beginning. The problem has scaled to break health care system of multiple countries. One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing outcome among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital, Kathmandu , Nepal .

NCT ID: NCT05326633 Not yet recruiting - Critical Illness Clinical Trials

Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors

ProMoTE
Start date: October 1, 2024
Phase: Early Phase 1
Study type: Interventional

Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.

NCT ID: NCT05159154 Not yet recruiting - Critical Illness Clinical Trials

Myocardial Work in Septic Shock Patients

MYWORKSS
Start date: January 1, 2022
Phase:
Study type: Observational

Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics, adding information on cardiac performance when compared with traditional parameters of left ventricle (LV) systolic function, such as ejection fraction (EF). However, their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload. Myocardial work (MW) is emerging as an alternative tool for studying LV myocardial systolic function, because it incorporates both deformation and load into its analysis. The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints. Secondarily, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.

NCT ID: NCT05132751 Not yet recruiting - Clinical trials for Mechanical Ventilation

Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation

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

Ventilator-induced lung injury is associated with increased morbidity and mortality. Despite intense efforts in basic and clinical research, an individualized ventilation strategy for critically ill patients remains a major challenge. However, an individualized mechanical ventilation approach remains a challenging task: A multitude of factors, e.g., lab values, vitals, comorbidities, disease progression, and other clinical data must be taken into consideration when choosing a patient's specific optimal ventilation regime. The aim of this work was to evaluate the machine learning ventilator decision system, which is able to suggest a dynamically optimized mechanical ventilation regime for critically-ill patients. Compare with standard controlled ventilation, to test whether the clinical application of the machine learning ventilator decision system reduces mechanical ventilation time and mortality.

NCT ID: NCT05112406 Not yet recruiting - Sepsis Clinical Trials

Early Diagnostic Biomarkers of Sepsis

Start date: December 2021
Phase:
Study type: Observational

A Comparison between CRP, ferritin, and serum zinc as early diagnostic biomarkers of sepsis in critically ill patients

NCT ID: NCT05085223 Not yet recruiting - Critical Illness Clinical Trials

Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

HYPNIC II
Start date: October 2021
Phase:
Study type: Observational

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis. This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.

NCT ID: NCT05083520 Not yet recruiting - Sepsis Clinical Trials

Incidence of Cereblon in Intensive Care Patients

Start date: December 1, 2021
Phase:
Study type: Observational

Classical immunomodulatory drugs (IMiDs) like thalidomide and its second- and third-generation analogues lenalidomide, pomalidomide, avadomide (CC-122), and iberdomide (CC-220) have constantly emerged to new therapeutic areas. Originally developed as a sedative and banned in 1961 for its teratogenic effects when used during pregnancy, thalidomide and a number of newly developed analogues are approved for the treatment of multiple myeloma (MM),4 erythema nodosum5 and myelodysplastic syndrome (MDS) Thalidomide was used as a treatment for morning sickness from 1957 until 1961 but was withdrawn from the market after it was discovered that it caused birth defects. Because of their pleiotropic and especially anti-angiogenic properties, IMiDs have further been reported effective in many off-label indications as for Hodgkin's lymphoma, light chain-associated (AL) amyloidosis, and acute myeloid leukemia (AML). The drug thalidomide binds to cereblon and changes which substrates can be degraded by it, which leads to an antiproliferative effect on myeloma cells and possibly the teratogenic effect on fetal development. The idea that cereblon modulation is responsible for the teratogenic activity of thalidomide in the chick and zebrafish was cast into doubt due to a 2013 report that pomalidomide (a more potent thalidomide analog) does not cause teratogenic effects in these same model systems even though it binds with cereblon more strongly than thalidomide. Cereblon (CRBN) is a substrate receptor of the E3 ubiquitin ligase complex. Several key findings suggest diverse roles of CRBN, including its regulation of the large-conductance calcium- and voltage-activated potassium (BKCa) channels, regulation of thalidomide-binding proteins, and mediation of lenalidomide treatment in multiple myeloma. Recent studies also indicate that CRBN is involved in energy metabolism and negatively regulates AMP-activated protein kinase signaling. Recent studies also indicate that CRBN is involved in energy metabolism and negatively regulates AMP-activated protein kinase signaling. Mice with genetic depletion of CRBN are resistant to various stress conditions including a high-fat diet, endoplasmic reticulum stress, ischemia/reperfusion injury, and alcohol-related liver damage. There are different drugs that have an immunomodulating effect, such as thalidomide analogs, and are used in various situations. Some of the diseases in which the immune system plays a role in its etiology are Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury (ALI), septic shock, and sepsis. In cases of lung injury such as sepsis, septic shock, ARDS, ALI, the immune system is over-activated and as a result, the immune system cells damage the own tissue of the lung. To break this mechanism, immunomodulatory drugs are used in intensive care in the treatment of these diseases. There is no publication regarding the role of Cereblon in the mechanism of action of these immunomodulatory drugs used in intensive care. In these intensive care diagnoses (sepsis, ARDS, ALI), there is no publication showing the correlation between the severity of the disease and Cereblon protein. Other laboratory parameters are used to estimate the effects (mortality and morbidity) of these diseases on the patient. At the end of the investigators study, the investigators think that the Cereblon gene can be used in this estimation of mortality or morbidity.

NCT ID: NCT05078645 Not yet recruiting - Critical Illness Clinical Trials

Improving Sleep and Reducing External Stimuli With the Maya

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

Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs. Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU. The Maya is a special "cover" which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy. With this pilot-study we aim to determine: - The feasibility and experiences of patients and healthcare professionals with the Maya. - To determine the effect size of dependent variables which can be used in future studies.

NCT ID: NCT05074862 Not yet recruiting - Critical Illness Clinical Trials

Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness.

KETO-ICU
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

Background: Patients with critical illness in the intensive care unit (ICU) experience marked skeletal muscle weakness, muscle atrophy and disability in physical function, commonly termed ICU-acquired weakness (ICU-AW). The pathophysiology of ICU-AW is complex, but a key feature of skeletal muscle wasting is disturbed protein metabolism reflected in both increased rate of muscle protein degradation and reduced synthesis. Treatment with 3-OHB seems a promising new anticatabolic treatment in patients with critical illness, preventing ICU-AW. To date, no data exist on the clinical and functional effects of ketone body modulation in patients with critical illness. Objective: The aim to investigate the effect of exogenous 3-OHB administration on muscle protein kinetics and lipolysis in patients with critical illness, aiming towards preventing ICU-AW. Design: A randomized double-blind isocaloric placebo-controlled cross-over study in 10 mechanically ventilated patients with critical illness in the ICU. Methods: Evaluation of whole-body and focal leg protein kinetics using labeled phenylalanine and tyrosine tracers. Assessment of free fatty acid (FFA) turnover using a labeled palmitate tracer. Femoral arterial blood flow (assessed with pulsed-wave Doppler ultrasound) is evaluated once per study period. Blood- and urinary samples are collected routinely throughout the study day. Whenever feasible, muscle and fat biopsies will be taken for analysis of protein and adipocyte metabolic signaling and mitochondrial function. Perspectives: This investigation may grant essential knowledge on ketosis in critical illness. This may lead to larger clinical trials, and hopefully a new and better treatment strategy aimed at preserving muscle mass and function during and improving recovery after critical illness.