Active clinical trials for "Critical Illness"

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention. Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking. This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.

Tracheal intubation, which is one of the most commonly performed procedures in the care of critically ill patients in intensive care unit, is associated with a high incidence of complications. Approximately 30% of emergent tracheal intubations in the ICU are associated with complications like hypotension, hypoxia, failed tracheal intubation, esophageal intubation, airway trauma, aspiration, cardiac arrest, and death. An observational study of tracheal intubation practices in critically ill patients across twenty-nine countries found cardiovascular instability to be the commonest among these adverse peri-tracheal intubation event. Tracheal intubation performed in a controlled, non-emergent setting, is associated with few complications. However in ICU, conditions like underlying shock, respiratory failure, metabolic acidosis, and other patho-physiological changes contribute to the increased peri-tracheal intubation complications. Post tracheal intubation hypotension frequently occurs within a few minutes following tracheal intubation. The additive effects of hypovolemia, the suppression of the endogenous activation of sympathetic response by the anesthetics drugs as well as the intrathoracic positive pressure due to mechanical ventilation are implicated in this cardiovascular collapse after tracheal intubation in critically ill patients. Post-tracheal intubation hypotension has been shown to be associated with higher in-hospital mortality and longer ICU and hospital length of stay. Hence patient optimization prior to tracheal intubation may be important to ensure hemodynamic stability to minimize further deterioration during tracheal intubation. Few techniques to optimize hemodynamics before tracheal intubation commonly involve the use of intravenous fluids and vasopressor medications; however, there are no standards of care guiding these practices. Jaber et al included pre tracheal intubation fluid loading (isotonic saline 500 ml or starch 250 ml) as a part of tracheal intubation care bundle management to show improved outcomes. However it was an observational study and also it was not possible to evaluate the contribution of the individual hemodynamic components of the bundle given the concurrent implementation of other interventions. And a recent study by Janz et al showed that pre loading with a 500-mL bolus of crystalloids before tracheal intubation did not identify any benefit. However this trial was stopped early for futility and moreover the volume of intravenous fluids that patients received before enrolment was not recorded. Few trials have used vasopressor bolus prior to tracheal intubation to avoid post tracheal intubation hypotension or use of prophylactic use of vasopressors in preventing post spinal hypotension. However currently, there are no randomized trials or evidence-based guidelines to support the choice between fluid loading or vasopressors for the tracheal intubation of critically ill adults. We would like to conduct a randomised controlled study comparing the effects of fluid bolus or low dose vasopressor given prior to tracheal intubation on post tracheal intubation hypotension among critically ill adults.

The aim of this prospective, randomized, active control, double blinded study is to assess the effect and safety of continuous infusion nefopam in mechanically ventilated ICU patients compared to standard of care. It is being hypothesized that continuous infusion nefopam will reduce opioid use with acceptable safety profile compared to standard of care.

Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to: 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy. 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health. 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). All 10 participants in the open trial phase received EMPOWER. Feedback from clinicians, bereaved stakeholders and results from the open trial were then used to refine the intervention and launch a multi-center randomized controlled trial to examine clinical superiority of EMPOWER to enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs of family caregivers impacted by the COVID-19 pandemic, we then launched a second single arm open trial and paused recruitment for the RCT. All participants recruited during the open trial COVID-19 phase received EMPOWER. Beginning in August 2021, we resumed the RCT portion of the trial to meet the initial recruitment goals of the study (total n of RCT & COVID-19 open trial=60).

The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2 software, developed by the model-based medical decision support of Aalborg University (Denmark) and adapted to the clinical needs in the intensive care unit (ICU) of the Geneva University Hospital (HUG). This new device is based on a mathematical model of the glucose-insulin metabolism and attempts to give advices for better glycaemia control and nutritional therapy. The GLUCOSAFE 2 study hypothesizes that the use of the Glucosafe 2 software will allow better glycaemia ("Time-in-target") control and better achievement of nutritional energy and protein targets in comparison to the local protocols.

The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).

Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.

At present, there is no clinical reference data on how much the concentration of calcifediol in the blood increases after supplementing with vitamin D for Taiwanese ICU patients. This study aims to investigate the effects of enteral supplementation of vitamin D in critically ill patients with vitamin D deficiency. The results of the study are expected to provide clinical reference data to intensivists to select adequate dosage of vitamin D supplementation for their patients with vitamin D deficiency. This is a multi-center, randomized clinical trial. ICU patients will receive vitamin D level examination. If the subject's blood calcifediol concentration is less than 20 ng / mL, the subject will be included in this clinical trial. Patients who are suitable to enteral supplement of vitamin D will be randomly divided to group Control (no vitamin D supplement) and group Vitamin D (enteral supplement of 569,600 IU vitamin D). The vitamin D level will be measures at specific time points.

Patients were randomized to receive either paracetamol during mechanical ventilation. When patients were randomized to receive paracetamol (40 mg/kg per day in 4 doses), a placebo infusion of normal saline was administered continuously at the same rate as an equivalent infusion. Placebos could not be distinguished from the active study drug in color, odor, or viscosity. In both study groups, IMV was maintained with sufentanil (0-0.2 mcg/kg/h), propofol (0-4 mg/kg/h), and dexmedetomidine (0-1 mcg/kg/h). Assessment of sedation levels by the bedside nurse using the FLACC pain scale to determine if the child is adequately comfortable or in need of more or less medication to maintain adequate ventilation. Assessment of sedation levels by the bedside nurse using the FLACC pain scale (every 6 hours as a minimum time interval).

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.