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Critical Illness clinical trials

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NCT ID: NCT02358577 Completed - Critical Illness Clinical Trials

Early In-bed Cycling in Critically Ill Children

wEECycle
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.

NCT ID: NCT02354521 Completed - Nutrition Clinical Trials

Nutrition Support During Pediatric Critical Illness - 2nd Multicenter, International Cohort Study

PINS2
Start date: August 2011
Phase: N/A
Study type: Observational

An observational, point-prevalence cohort study of nutrition therapies in critically ill children in PICUs across the world. Baseline information will be collected including PICU and hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score, weight, height) of critically ill children requiring mechanical ventilation in the PICU. Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed and received, interruptions, etc., will be collected on a daily basis from PICU admission onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days after admission to the PICU. The main objective of the study is to examine the association between energy and protein intake adequacy (in relation to the prescribed goals for these nutrients) and 60-day mortality in mechanically ventilated children.

NCT ID: NCT02344043 Completed - Sepsis Clinical Trials

Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

CONFOCAL
Start date: March 2014
Phase: N/A
Study type: Observational

Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications. Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration. Potential Harms, Risks or Discomforts: This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.

NCT ID: NCT02337556 Completed - Clinical trials for Critically Ill Mechanically Ventilated Subjects

The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

Start date: November 2014
Phase: N/A
Study type: Interventional

To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.

NCT ID: NCT02318290 Completed - Clinical trials for Substance Withdrawal Syndrome

Opioids Withdrawal Syndrome in Critically Ill Patients: a Multicenter Prospective Cohort Study

WAAICUP
Start date: January 2015
Phase: N/A
Study type: Observational

Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies. Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.

NCT ID: NCT02316990 Completed - Stress Ulcers Clinical Trials

China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients

SUP
Start date: January 2015
Phase: N/A
Study type: Observational

Stress ulcers or stress-related mucosal disease (SRMD) is defined as "acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands."[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients. Objectives of this Non-Interventional Study Primary 1. Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China. 2. Main secondary objective - To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China. - To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China. - To assess time to upper GI bleeding after a cerebral lesion. - To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients. - To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding. - To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis. - To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube. (ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)

NCT ID: NCT02308631 Completed - Fecal Incontinence Clinical Trials

Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy

EACC
Start date: February 2014
Phase: Phase 1
Study type: Interventional

Indications for colostomy are rectal or anal cancer, diverticular disease, radiation enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and functional disorders. It is frequently required in critically ill patients who may not be able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for colostomy without laparotomy, but require general anesthesia. Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall. The objective of this study is to evaluate the feasibility of performing fecal diversion with the help of a colonoscope and colopexy, without the additional morbidity of abdominal exploration.

NCT ID: NCT02306746 Completed - Critical Illness Clinical Trials

The Augmented Versus Routine Approach to Giving Energy Trial

TARGET
Start date: June 16, 2016
Phase: Phase 3
Study type: Interventional

Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.

NCT ID: NCT02304341 Completed - Critical Illness Clinical Trials

Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study

Start date: September 2012
Phase: N/A
Study type: Observational

Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.

NCT ID: NCT02301273 Completed - Critical Illness Clinical Trials

Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy

Start date: November 2011
Phase: N/A
Study type: Interventional

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.