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Critical Illness clinical trials

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NCT ID: NCT05663905 Completed - Critical Illness Clinical Trials

Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients

Start date: January 7, 2023
Phase: Phase 4
Study type: Interventional

Ambroxol is a mucolytic containing an active N-desmethyl metabolite of bromhexine. It is approved by both the U.S. FDA and EMA to be marketed under several formulations including oral, nasal, oro-mucosal, rectal and intravenous formulations. One of ambroxol's authorized use is for the treatment of bronchopulmonary infections. In addition, it has been found over the decades to have other multi-pronged properties such as local anaesthesia, anti-inflammatory and anti-oxidant effects. It also stimulates surfactant production in Type II pneumocytes, thus preventing atelectasis in pneumonia. Ambroxol has demonstrated a wide safety profile and is an extensively studied drug in terms of safety with the commonest side effects being skin rashes, allergies, nausea, vomiting, abdominal pain and dyspepsia. Severe pneumonia is is defined by the American Thoracic Society (ATS) as pneumonia that requires ICU admission and specifically fulfils one of two major criteria, or three out of nine minor criteria as per recommended in the latest ATS guideline. This study aims to investigate the effects of using intravenous ambroxol as an adjunct therapy on the resolution of severe pneumonia. The improvements in modified Clinical Pulmonary Infection Score (CPIS) will be used as a surrogate for resolution of severe pneumonia. Modified CPIS is a clinical score of 0-12 based on 6 clinical features: volume and character of tracheal secretions, chest radiograph infiltrates, body temperature, leukocyte count, oxygenation index, and microbiology results. Traditionally, CPIS score has been used to facilitate the diagnosis of VAP where a cut-off point of >6 is used to denote possible pneumonia. Interestingly, Luna et al has found that serial improvements in CPIS score can be successfully used as a surrogate for pneumonia resolution with good correlation with eventual survivability. This study will also explore the effects of using ambroxol on other clinical outcomes of patients with severe pneumonia, including ICU mortality, duration of ICU stay, length of mechanical ventilation and incidence of reintubation within 48 hours. If this adjunct treatment is able to reduce duration of ICU stay and length of MV, it will not only directly impact the patients' short & long term outcomes but will also confer logistical benefits in terms of saving resources and reducing healthcare economic burden while optimizing ICU turnover rates.

NCT ID: NCT05657678 Recruiting - Clinical trials for Vitamin D3 Deficiency

Vitamin D3 Supplementation in Critically Ill Patients Undergoing CRRT

NephroD
Start date: December 20, 2022
Phase: Phase 4
Study type: Interventional

Patients hospitalized in intensive care units (ICU) are particularly susceptible to vitamin D3 deficiencies. This can be due to the severity of their underlying disease, the type of treatment they are on, malnutrition before and inadequate nutrition during the hospitalisation preceding ICU admission, as well as advanced age. It has also been established that plasma levels of 25(OH)D3 tend to systematically decrease during ICU treatment. Therapeutic interventions administered in ICU settings such as fluid resuscitation or extracorporeal therapies can cause additional vitamin D3 deficiencies. The incidence of deficiency in critically ill patients can reach up to 90%, and even 30% of ICU patients can have undetectable plasma levels. It is impossible to replenish vitamin D3 levels in critically ill patients with traditional enteral and parenteral nutrition treatment regimens, because nutritional products contain too little of the vitamin. Vitamin D3 deficiency in critically ill patients has been associated with acute kidney injury, acute respiratory failure, sepsis, septic shock and increased all-cause ICU mortality. Despite that, assessment of plasma 25(OH)D3 levels is not a routine practice in ICUs. In view of the prevalence of vitamin D3 deficiencies in ICU patients, rapid replenishment of this deficiency with an increased supplementation dose should be considered as a potential means to improve prognosis in this patient population. The current standard therapy is the administration of 500,000 IU of vitamin D3 via the enteral route in ICU patients with severe deficiency (recommended by ESPEN). The NephroD study is meant to help answer the question whether increasing the standard ICU supplementation dose of vitamin D3 by 50% will ensure a more effective replenishment of this vitamin in critically ill patients undergoing CRRT.

NCT ID: NCT05635903 Recruiting - Critical Illness Clinical Trials

Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

Start date: December 22, 2019
Phase: N/A
Study type: Interventional

Critically unwell patients in Intensive Care have a decreased ability to effectively clear secretions. High secretion load is a major risk factor in the failure of tracheal extubation failure and the requirement for reintubation. Extubation failure is a predictor of poor outcome independent of the severity of the underlying illness. Nebulisation of isotonic saline can be employed to manage secretions by reducing the secretion viscosity and facilitating clearance of respiratory sections during tracheal suction. Standard jet nebulisers have been the mainstay of respiratory section management therapy in critical care since the early 1990s. A more recent development has been the vibrating mesh nebuliser. There is evidence of improved humidification and reduced water particle size and theoretically better transfer to the distal airways.

NCT ID: NCT05634135 Recruiting - Clinical trials for Prolonged Mechanical Ventilation

Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation

Start date: July 31, 2022
Phase:
Study type: Observational

This project will conduct a series of analysis of physiological and clinical data on tracheostomy patients who receive prolonged mechanical ventilation, hoping to find out the different manifestations of patients through the investigation by a variety of physiologic measurements, so as to understand whether different types of patients phenotype to derive different clinical strategies for liberation of the mechanical ventilator.

NCT ID: NCT05628844 Not yet recruiting - Critical Illness Clinical Trials

Nutrient Uptake During Continuous Enteral Feeding

Start date: January 1, 2023
Phase:
Study type: Observational

Continuous enteral nutrition is used to feed patients in intensive care who are unable to eat normally. The goal of this observational study is to learn about the uptake of nutrients from feeding formula. The study method will first be applied in healthy persons to establish workability and normal values, then in patients in the intensive care unit to learn how nutrient uptake is affected by critical illness. The main questions this study aims to answer are: - what is the time course of uptake of phenylalanine (an amino acid) and glucose (a sugar) from enteral feeding formula given continuously over several hours - what is the time course of the filling volume of the stomach during continuous enteral feeding Participants receive feeding formula through a nasogastric feeding tube and blood samples are taken at short intervals to analyse uptake of nutrients into blood. Simultaneously, the filling volume of the stomach is measured by gastric ultrasound.

NCT ID: NCT05616130 Recruiting - Sepsis Clinical Trials

Pathological Myeloid Activation After Sepsis and Trauma

Start date: September 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to better understand what happens to circulating blood after a patient experiences severe trauma injury. The main questions it aims to answer are: Is severe human trauma associated with specific patterns of development in the hematopoietic stem cells of these patients? and Does the initial severe trauma injury create immunosuppression and increase risk of in-hospital sepsis? Participants in study will give blood samples and a waste sample of bone marrow at time of operative repair of traumatic orthopedic injuries, supply medical information and participate in surveys and assessments during recovery from their injury(ies). Researchers will compare severe trauma injury patients to elective hip repair patients to see if immunosuppression and specific development patterns occur in the trauma patient versus the otherwise healthy hip surgery patient.

NCT ID: NCT05608096 Recruiting - Sepsis Clinical Trials

European Registry for Hemadsorption in Sepsis With the Seraph Filter

Start date: October 25, 2022
Phase:
Study type: Observational [Patient Registry]

Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates. Sepsis can be induced by either viremia, bacteriemia or in some cases both. Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions. Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders. The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.

NCT ID: NCT05591950 Recruiting - Critical Illness Clinical Trials

Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)

TAVIMS
Start date: January 24, 2023
Phase:
Study type: Observational

Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS). The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.

NCT ID: NCT05591924 Not yet recruiting - Sepsis Clinical Trials

Early Severe Illness TrAnslational BioLogy InformaticS in Humans

ESTABLISH
Start date: January 11, 2024
Phase:
Study type: Observational [Patient Registry]

Advanced stages of the response to life-threatening infection, severe trauma, or other physiological insults often lead to exhaustion of the homeostatic mechanisms that sustain normal blood pressure and oxygenation. These syndromic presentations often meet the diagnostic criteria of sepsis and/or the acute respiratory distress syndrome (ARDS), the two most common syndromes encountered in the intensive care unit (ICU). Although critical illness syndromes, such as sepsis and ARDS, have separate clinical definitions, they often overlap clinically and share several common injury mechanisms. Moreover, there are no specific therapies for critically ill patients, and as a consequence, approximately 1 in 4 patients admitted to the ICU will not survive. The purpose of this observational study is to identify early patient biologic factors that are present at the time of ICU admission that will help diagnose critical illness syndromes earlier, identify who could benefit most from specific therapies, and enable the discovery of new treatments for syndromes such as sepsis and ARDS.

NCT ID: NCT05591625 Recruiting - Critical Illness Clinical Trials

Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission

EMERALD
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness. Participants will: - be recruited at hospital discharge - undergo a psychological assessment at 2-3 months post-hospital discharge - Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR - Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm. - All participants will repeat the psychological assessment 12-months after hospital discharge. Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months. The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.