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32 active trials for Critically Ill

INTENT-Muscle (A Sub-study of INTENT)

The currently recruiting randomised controlled trial "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (INTENT, NCT03292237) is the first multi-centre trial to compare an intensive, individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients. INTENT-Muscle, is an observational longitudinal study nested within INTENT. The aim of INTENT-Muscle is to compare longitudinal changes in muscle health (assessed by bioimpedance and muscle ultrasound) in critically ill patients randomised to each arm of INTENT.

Start: May 2021

Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient

The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Start: April 2021

ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.

Start: March 2021

Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.

Start: April 2020

Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS

The purpose of this study is to determine the most suitable dose of Fludrocortisone in reversal of sepsis and shock associated with sepsis in patients who are admitted to the ICU. The investigators will be looking to see whether patients receiving Fludrocortisone at different doses recover quicker and spend less time in hospital and in ICU, and to understand the reasons why this happens at certain doses. Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body. Fludrocortisone is a steroid that has previously shown to be beneficial to help in shock in patients in ICU, but more information is required about the exact dose that is required to achieve this. This has been shown by previous research. However, the exact role of Fludrocortisone and the best dose has not been studied adequately to date as well as the ways in how it works within the body. The study aims to look tat the dose and the way it works.

Start: February 2021

Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients

Objective: Test the ability of vibration to produce physiologic, biochemical, and anatomic changes consistent with exercise that would help prevent the development of muscle weakness that occurs when patients are immobile for long periods of time.

Start: March 2018

Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

Start: September 2020

Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit

Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit

Start: April 2021

Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.

Start: November 2019

Protein Supplementation in Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial

This pilot trial is part of a long-term research program leading to a large trial to determine if a strategy of supplementing protein in a subset of critically ill children is superior to standard enteral nutrition care. The investigators hypothesize that protein supplementation to critically ill children with body mass index (BMI) z-score ? -2 reduces the length of stay in the paediatric intensive care unit (PICU) and hospital, as well as the duration of mechanical ventilation (MV).

Start: January 2021

Microcirculation in Spontaneous Breathing Trial

Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.

Start: December 2019

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness

The World Health Organization, U.S. Centers for Disease Control and Prevention, Association of Medical Microbiology and Infectious Diseases (AMMI) Canada, and Health Canada have all declared antimicrobial resistance a global threat to health, based on rapidly increasing resistance rates and declining new drug development. Up to 30-50% of antibiotic use is inappropriate, and excessive durations of treatment are the greatest contributor to inappropriate use. Shorter duration treatment (?7 days) has been shown in meta-analyses to be as effective as longer antibiotic treatment for a range of mild to moderate infections. A landmark trial in critically ill patients with ventilator-associated pneumonia showed that mortality and relapse rates were non-inferior in patients who received 8 vs 15 days of treatment. Similar adequately powered randomized trial evidence is lacking for the treatment of patients with bloodstream infections caused by a wide spectrum of organisms.

Start: February 2017

Intensive Nutrition in Critically Ill Adults

Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; interventions have been short in duration (usually 3-10 days after intensive care unit (ICU) admission), perhaps applied at the incorrect time in regards to the patients metabolism and recovery, do not consider the patients nutrition risk, and have not addressed what happens to nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date have not observed any positive associations with the delivery of nutrition; our focus to date may have been on the wrong stage of illness. A future study is thus urgently needed, which addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole hospital stay and collecting meaningful clinical, process and outcome data, which will potentially inform a larger trial of a similar nature. This initial study aims to determine whether optimization of energy using a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention in the post ICU period will deliver more total energy than standard nutrition care during hospital admission in a group of critically ill patients with at least one organ system failure.

Start: October 2018

Ultrasound of the Diaphragm in ICU Patients

Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients. Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.

Start: May 2013

IMPACT STUDY: Investigating Microbial Pathogen Activity of Copper Textiles

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

Start: January 2016

Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens. With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.

Start: July 2020

Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients

The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.

Start: December 2019

Prevalence of Chronic Pain and Its Risk Factors After a Surgical Intensive Care Unit Stay. Prospective Observational Cohort

The objective of this observational, prospective study is to evaluate the incidence of chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ?3 days). Investigators will assess the proportion of patients with chronic pain (defined according to the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge. All data potentially associated with chronic pain will be collected, including the type of surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of opioids received, patients comorbidity... Patients will be follow-up at 6 and 12 months to identify impact on quality of life.

Start: May 2020

Acute Encephalopathy in Critically Ill Patients With COVID-19

Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare. The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients. Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity. Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients. We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

Start: March 2020

The EXCEL Registry of Patients Requiring ECMO

ECMO is associated with significant costs, risks and requires specialist training and expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients requiring ECMO in Australia and New Zealand. The registry provides information on patient selection, complications, costs and patient reported outcome measures. EXCEL uses the Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and enablers to tailor implementation of evidence

Start: February 2019