Active clinical trials for "Critical Illness"

Background: Staffing in intensive care units (ICU) has been in the spotlight since the pandemic. Having enough nurses to deliver safe, quality care in ICU is important. However, what the skill mix should be (how many should be qualified nurses or have an ICU qualification) is unclear. Very little research has been done to look at which nursing staff combinations and mix of skills works best in ICU to support patients (described as 'staffing models').Research shows that there is a link between the quality of nurse staffing and poor patient outcomes, including deaths. Aim: Our research plans to look at different staffing models across the UK. This study aims to examine new staffing models in ICU across six very different Trusts. This study will use a research technique called Realist Evaluation that examines what works best in different situations and help to understand why some things work for some people and not others. The design of this approach will help to better understand the use of different staff ratios across different ICU settings. This study will examine what combinations of staff numbers and skills result in better patient care and improved survival rates. The aim is to produce a template that every ICU unit can use. To do this, this study will compare staffing levels with how well patients recover, and seek to understand the decisions behind staffing combinations. Methods: This study will: carry out a national survey to understand the different staff models being used, comparing this against the current national standard (n=294 ICUs in the UK including Scotland) observe how people at work in 6 hospitals (called ethnography), watching how they make decisions around staffing and the effect on patients. The investigators will also conduct interviews (30 interviews plus 30 ethnographic observations) to understand staffing decisions. look at ICU staffing patterns and models, and linked patient outcomes (such as whether people survive ICU) over 3 years (2019-2023) in those hospitals, including with a very different combination of staffing). The investigators will then carry out some mathematical calculations to understand the best possible staffing combinations, and how this varies.

Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.

Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions. Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.

Patients who have been admitted to Intensive Care Units (ICU) and are intubated and mechanically ventilated for longer than 48 hours have impaired physical, psychological and social health and well-being six to twelve months after discharge. The advocacy of intensive physiotherapy and mobilization early in the course of critical illness has been established. It is of great importance to study the long-term outcomes (physical function and quality of life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as soon as possible during ICU stay because the most effective mode, intensity or frequency of exercise needs to be identified. The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and upright position in critically ill patients on prolonged invasive ventilation and to develop principles to guide physiotherapists in their clinical decision making in the ICU.

This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.

The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit. Patients that require a breathing tube to be placed in the ICU will be randomized to receIve either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the breathing tube.

Sepsis has been characterised as a dysregulated host response to infection. Adjunctive therapies targeting the inflammatory cascade are being increasingly explored, although to date, have failed to demonstrate consistent benefit, and sepsis continues to manifest poor outcomes. Hospital mortality in patients with septic shock remains as high as 22% in Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe sepsis cases are expected to be treated in hospitals all over the world per year. To date, experimental data have reported that both high dose intravenous vitamin C and corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce the endothelial injury characteristic of sepsis, enhance the release of endogenous catecholamines and improve vasopressor responsiveness. Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre, randomised, open-label, trial in ICU patients with septic shock to test whether the intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.

Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.

The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.