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Critical Illness clinical trials

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NCT ID: NCT01865708 Completed - Clinical trials for Complication of Urinary Catheter

Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

Start date: July 2013
Phase: Phase 1
Study type: Interventional

Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol concentration of <0.025%) after a 1 hour urinary catheter ethanol lock. Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.

NCT ID: NCT01847534 Completed - Critical Illness Clinical Trials

Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial

Start date: February 2014
Phase: Phase 2/Phase 3
Study type: Interventional

One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery. Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach. In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.

NCT ID: NCT01844492 Completed - Depression Clinical Trials

Improving Patient and Family Centered Care in Advanced Critical Illness

PARTNER
Start date: July 23, 2012
Phase: N/A
Study type: Interventional

One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.[8, 9] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.[10, 11] In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.

NCT ID: NCT01834430 Completed - Clinical trials for Inflammatory Intestinal Obstruction

Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Start date: February 2010
Phase: Phase 3
Study type: Interventional

Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.

NCT ID: NCT01827358 Completed - Clinical trials for Staphylococcal Infection

Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants

Start date: April 30, 2014
Phase: Phase 2
Study type: Interventional

The objective of this trial is 1) to evaluate the safety and clinical acceptability of a 5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to examine the efficacy of mupirocin in achieving persistent eradication of SA colonization among infants residing in the ICU,defined as the absence of SA in cultures of the nares, umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to receive medical care as they otherwise would if they were not enrolled in the trial. The study will be powered with a primary endpoint with 126 participants. Enrollment may continue to 500 participants to power secondary and exploratory endpoints and assist design subsequent studies.

NCT ID: NCT01800448 Completed - Critical Illness Clinical Trials

Variability Analysis During Weaning and Extubation in Critically Ill Patients

NM3
Start date: June 2012
Phase: N/A
Study type: Observational

For critically ill patients, it is important to know when to liberate them from mechanical ventilation (the removal of breathing or endotracheal tube or extubation) and weaning (the progressive decrease of the amount of support that a patient receives from the mechanical ventilation). It is well recognized that prolonged ventilation and weaning harms patients and introduces significant increased costs to the health care system. The investigators objective is to improve the safety of removal of life support in critically ill patients by harnessing information from two new technologies; NM3 and Nexus device. In particular, the investigators are interested in the patterns of variation of respiratory and cardiac signals from the NM3 device, as well as monitor skin conductance with the Nexus device. The combination of these measures has not yet been investigated to date, and could represent a novel set of measures that can be used to help physicians better manage critically ill patients. The current standard of care dictates that once a patient is considered as a candidate for withdrawal from ventilation, a spontaneous breathing trial (SBTs) is performed, where the degree of ventilator support is decreased, and their response is observed to help predict if they will tolerate extubation. Health is associated with a high degree of variation of physiologic parameters such as heart rate and respiratory rate, and illness & stress are associated with a loss of variability. The analysis of variability of biological signals measures the degree of fluctuations present over time. Previous studies have demonstrated that changes in variability (generally decreases) are observed in illness states, and the degree of this change correlates with illness severity. Several studies have reported that reduced heart or respiratory rate variability (HRV or RRV) during SBTs is associated with extubation failure. Until recently, variability analysis has traditionally been done only on heart rate (HRV), derived from analyzing beat-to-beat intervals from the ubiquitous electrocardiogram (ECG). The investigators aim to apply variability analysis to the respiratory and cardiac signals which represent a rich novel set of muti-organ variability measures whose utility in managing extubation and ventilator weaning has not been investigated to date.

NCT ID: NCT01799512 Completed - Critical Illness Clinical Trials

Glucose Control in the ICU Using Continuous Glucose Monitoring

REGIMEN
Start date: July 2007
Phase: N/A
Study type: Interventional

Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia. This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.

NCT ID: NCT01796847 Completed - Critical Illness Clinical Trials

Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients

GLUPTEN
Start date: December 2012
Phase: N/A
Study type: Observational

Glycemic variability in critically ill patients is a recognized negative prognostic factor. The molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to influence glucose homeostasis by interfering in intracellular insulin signaling. Aim of this study is to ascertain whether differential expression of PTEN in critically ill patients correlates with glycemic variability and clinical outcome.

NCT ID: NCT01794468 Completed - Clinical trials for Critically Ill Patients

A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study

MDBF-CIP
Start date: June 2003
Phase: N/A
Study type: Interventional

Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs. Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients. Preliminary Study Study Population: critically ill patients in a general ICU

NCT ID: NCT01792401 Completed - Critical Illness Clinical Trials

Probiotics in Enteral Feeding in Critically Ill Patients

Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit.