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Critical Illness clinical trials

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NCT ID: NCT01760044 Completed - Sepsis Clinical Trials

Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

Start date: January 2013
Phase: N/A
Study type: Interventional

Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.

NCT ID: NCT01757912 Completed - Clinical trials for Mechanical Ventilation With Oral Intubation

Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients

CP
Start date: February 2011
Phase: N/A
Study type: Interventional

The endotracheal tube secures free airway in patients undergoing surgical procedures or mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A cuff pressure in excess of the target range is associated with a risk of tracheal injury, whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown whether the cuff pressure changes following changes in body position of the patient. The objective of this study is to investigate to which extent - if any - cuff pressures change after body position changes of the patient.

NCT ID: NCT01753024 Completed - Diabetes Clinical Trials

Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients

Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

Malnutrition is a frequent problem in critically ill patients that is associated with detrimental clinical outcomes. To provide adequate nutritional support, current studies focused mostly on the choice of delivery timing, formula selection and the route of administration, little attention was paid to malnutrition related to exocrine pancreatic insufficiency (EPI). In fact, malnutrition is also a major consequence of pancreatic exocrine insufficiency and pancreatic damage is commonly observed in critically ill patients without prior pancreatic diseases. Hence, EPI associated malnutrition should be concerned due to the high prevalence of pancreatic damage in critically ill patients. The aims of this study is to evaluate the incidence of EPI in critically ill adult patients and explore its potential risk factors. Moreover, the efficacy of pancreatic enzyme supplementation therapy on malnutrition in ICU patients with specific clinical characteristics will be investigated.

NCT ID: NCT01750463 Completed - Hemoglobin Results Clinical Trials

Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children

Start date: January 2013
Phase: N/A
Study type: Observational

This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.

NCT ID: NCT01737021 Completed - Critical Illness Clinical Trials

Improving Outcomes After PICU Admission: A Pilot Study

Start date: November 2012
Phase: N/A
Study type: Interventional

1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care; 2. Evaluate the feasibility and acceptability of the study design and procedures; 3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU; 4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention; 5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

NCT ID: NCT01734252 Completed - Clinical trials for Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance

Argatroban in Critically Ill Patients With Heparin Resistance

Start date: July 29, 2012
Phase: Phase 2
Study type: Interventional

Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H. All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours. Randomisation Group A: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. Randomisation Group H - Standard therapy: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. Therapy failure Group H: Primary target failure at Visit 3 (6-8 hours): If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30). Maintenance failure after Visit 3: Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban. The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A. Therapy failure Group A: If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study. The same is effective for patients who switched to the Group A after a therapy failure in Group H. General: Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9).

NCT ID: NCT01728558 Completed - Clinical trials for Critical Illness and Mechanical Ventilation

Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

SPICE III RCT
Start date: November 2013
Phase: Phase 3
Study type: Interventional

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers: 1. Early randomization after intubation or arrival in the ICU (intubated). 2. Early Adequate analgesia after randomization. 3. Goal directed sedation titrated to achieve light sedation. 4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines. The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.

NCT ID: NCT01726595 Completed - Critical Illness Clinical Trials

Ultrasound Measurement of Reactive Hyperemia in Critical Care

URHC
Start date: January 2013
Phase:
Study type: Observational

The investigators hypothesize that doctors and nurses can undergo a brief period of training and then use ultrasound to accurately measure blood flow in a forearm artery after a brief period when this flow is interrupted with a blood pressure cuff, a measurement the investigators call reactive hyperemia. Reactive hyperemia indicates whether the small blood vessels in the body are healthy -- lower reactive hyperemia indicates worse small blood vessel function. When measured by experienced ultrasound experts, low reactive hyperemia strongly predicts death in critically ill patients with infection (severe sepsis). The investigators are conducting this study to determine if doctors and nurses, without specific pre-existing expertise in ultrasound, can be trained to make these measurements accurately. If so, the investigators will prove that these measurements can be applied reliably in real-world practice. The investigators also hypothesize that reactive hyperemia predict the outcomes of illness not just in patients with severe infection, but in other critically ill patients as well. Finally, the investigators hypothesize that reduced blood flow after blood pressure cuff occlusion is linked with other abnormalities of blood, previously identified in critically ill patients. For example, red blood cells from patients with severe sepsis have been shown to be stiffer than normal, so they are less able to flow along the small blood vessel passages of the body. Red blood cells become stiffer when there is a certain type of stress in the body known as "oxidative stress." If the investigators show that low reactive hyperemia, stiff red blood cells, and oxidative stress are linked, the investigators hope to develop new treatments that reduce oxidative stress, reduce the stiffness of red blood cells, and in turn improve reactive hyperemia. Improvements in reactive hyperemia indicate improvements in small blood vessel function. Better small blood vessel function means better delivery of oxygen throughout the body. The investigators believe that this will improve outcomes for critically ill patients.

NCT ID: NCT01724593 Completed - Critical Illness Clinical Trials

Functional Recovery in Critically Ill Children

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

Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children: - Pre-morbid condition - Age - Time-to-initiation of acute rehabilitation - Critical illness disease severity

NCT ID: NCT01716988 Completed - Critical Illness Clinical Trials

Pharmacokinetics of Micafungin in Critically Ill Patients

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

A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied. The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.