Active clinical trials for "Critical Illness"

The overall aim is to examine the impact of trauma and critical illness on the brain, peripheral immune system and cognition. This is a prospective study where a study group exposed to trauma and intensive care will be be examined with consecutive PET imaging, EEG, biomarkers and cognitive testing within 3 weeks of the trauma, after 3 months and finally after 12 months. The study group will consist of twenty trauma patients treated in the intensive care unit.

Introduction: Lactoferrin has several uses due to its effects. It has anti-inflammatory, antioxidant, immunomodulatory, antibacterial, antifungal, and antiviral effects. Its safety is proven by food and drug administration. Aims: The objective is to study the effect of lactoferrin on improving clinical outcomes in ICU patients when compared to placebo, and also to evaluate its safety. Patients and populations: A sample of 650 patients (325 patients in both groups A, and B) who will be admitted to ICU departments in Mansoura university hospital will be used to represent the population in ICU. Methods: A sample of 650 participants was randomized 1:1 into two groups (group A (325 patients), and group B (325 patients)). This study is a double-blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.

The purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes. The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

Background: Severe acute kidney injury (AKI) among critically ill patients is sometimes treated with renal replacement therapy (RRT), and in Sweden continuous RRT (CRRT) is the dominant modality used in this population. The optimal timing of renal replacement therapy (RRT) initiation in critically ill patients with acute kidney injury (AKI) is unknown No consensus to guide clinical practice on this issue Lack of consistency regarding outcome measurements; should we look at morbidity or mortality? Wide variability in the timing of RRT initiation in the intensive care unit (ICU) population Hypothesis: This is an important knowledge gap in the support of critically ill patients with AKI and we hypothesize that early initiation of RRT is beneficial. Methods: The present study aims to test this hypothesis by using a large scale high resolution intensive care database, the Clinisoft repository. In this database, we have information on >60 000 patients from three different hospitals and five ICUs, during the years 2005 up until today. The repository will be crossmatched, using the unique Swedish national ID number, with hospital records; to gather information on preexisting illnesses, chronic medication and post-ICU outcomes. It is likely that over 5%, more than 3000 patients, have been treated with RRT. We will categorize these patients into "early" and "late" groups using both biomarker data and clinical data. Importantly, early and late RRT can be categorized using biomarkers, like urea and creatinine; using degree of fluid accumulation, by level of pH in blood and just by using hours-days after ICU admission. All possible definitions of early/late RRT initiation can be tested in this study. Outcomes: Our primary outcome is 90 day mortality. Secondary outcomes include: mortality at 30, 60, 180 and 365 days. Two- and three year mortality. Morbidity, measured as end-stage renal disease (ESRD) for 90-day survivors. ICU length of stay, hospital length of stay.

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.

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.

The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives. The main question[s] it aims to answer are: Will people join the study? (recruitment) Will participants finish the study? Will healthcare teams accept the study procedures? Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 1 year.

Critical illness-related corticosteroid insufficiency (CIRCI), a term coined since 2008 by Society of Critical Care Medicine (SCCM), and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive Care Unit (ICU) patients.1 Severe Sepsis with shock is a common reason for admission to ICU/hospital and may require ionotropic support.2 The current guidelines from SCCM in 2017 suggest using either random cortisol of < 10 ug/dL (<276 nmol/L) or change in cortisol at 60 min after cosyntropin (250 µg) administration from baseline cortisol of <9 µg/dl (<248 nmol/L) to assess of presence of CRCI and recommend use of hydrocortisone in these patients.3 There have been studies done to look at baseline cortisol in patient with severe pneumonia requiring ICU and they have found cortisol level of < 15 ug/dl (<414 nmol/L) can predict CIRCI.4 However, there is no study on assessment of baseline random cortisol levels in patients with septic shock in our local population. The current guidance from Surviving Sepsis campaign suggests a more clinical approach of adding IV corticosteroids only if there is ongoing requirement for vasopressors, which is a new change in contrast to 2016 guidelines.5 This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.

This study aims to investigate whether an AI prediction model based on blood cell multi-modal data can achieve early warning of survival risk in critically ill children through a large-scale multi-center cohort of critically ill children.