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Critical Illness clinical trials

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NCT ID: NCT02963558 Completed - Critical Illness Clinical Trials

A Study Promoting Critical Illness Recovery in the Elderly

ASPIRE
Start date: May 30, 2017
Phase: N/A
Study type: Interventional

This proposal will test the hypothesis that EARLY application of a novel early rehabilitation therapy in critically ill patients will improve functional outcomes, and change the functional trajectory of this population. A pilot study of early mobilization with a cycle ergometer will be performed and translate into humans the pre-clinical mechanisms that may mediate the effects of early mobility. A second phase of the study was added in September 2019, which will focus on clinical outcomes.

NCT ID: NCT02962102 Completed - Acute Kidney Injury Clinical Trials

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

ACTIVATE-AKI
Start date: April 3, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.

NCT ID: NCT02945748 Completed - Clinical trials for Hemodynamic Instability

Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Start date: July 2016
Phase:
Study type: Observational

Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies. All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.

NCT ID: NCT02945241 Completed - Sepsis Clinical Trials

Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project

Start date: April 2014
Phase: Phase 1
Study type: Interventional

Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.

NCT ID: NCT02936440 Completed - Critical Illness Clinical Trials

Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis

Start date: May 2011
Phase: N/A
Study type: Observational

The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears to be a viable method to access the fluid status of critical patients but has never been evaluated in critical patients with AKI. The objective of this study is to evaluate the hydration status using BIVA in critical patients under intensive care at the time of AKI diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI will be evaluated by BIVA and followed until they are discharged or death in intensive care unit and the BIVA vectors will be analysed to define differences in hydration characteristics from each group.

NCT ID: NCT02921776 Completed - Critical Illness Clinical Trials

Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

Start date: February 19, 2018
Phase: N/A
Study type: Interventional

This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive patient communication solution for communication-impaired patients in the intensive care unit that may help decrease days in delirium, decrease anxiety levels, and reduce sedation exposure which are proximal outcomes known to be associated with decreased mechanical ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The primary goal of this Phase II STTR proposal is to further define user requirements and product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad communication software, to provide mechanically ventilated (MV) patients an evidence-based solution for effectively communicating their needs to care providers and family. A secondary goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed methods including observations and interaction with hospitalized patients as they use the VidaTalk tool, surveys and medical record data extraction, product evaluation and brief interview, satisfaction surveys with family members of ICU patients, and focus groups with Registered Nurses. Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices. Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical setting. Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application). Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale. Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.

NCT ID: NCT02920684 Completed - Sedated Patients Clinical Trials

Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Start date: December 2016
Phase: Phase 3
Study type: Interventional

Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed. Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied. The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

NCT ID: NCT02916004 Completed - Critical Illness Clinical Trials

The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.

Start date: September 26, 2016
Phase: N/A
Study type: Interventional

The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients. Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)

NCT ID: NCT02912624 Completed - Critical Illness Clinical Trials

Simple Intensive Care Studies I (SICS-I)

SICS-I
Start date: March 27, 2015
Phase:
Study type: Observational [Patient Registry]

Circulatory shock is a condition of generalized inadequate blood flow through the body, leading to insufficient tissue perfusion and inadequate delivery of oxygen and other nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory failure are distinguished, caused by a scale of underlying illnesses: distributive, hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a low cardiac output and hypovolemia. Distributive shock is characterized by peripheral circulation failure, with a low systemic vascular resistance, a disturbed microcirculation and a high cardiac output. Frequently, these forms overlap. Shock is a common problem in the intensive care unit (ICU) as it affects about one third of the patients. Septic shock appears to be the most common type, followed by cardiogenic and hypovolemic shock. The diagnosis of shock is based on clinical examination with use of well-known circulatory parameters such as blood pressure and heart rate; biochemical parameters such as lactate and direct (semi-)invasive measurement of cardiac output and other variables. Since cardiac output is an important determinant of oxygen delivery, many different methods of measuring cardiac output have been suggested. These methods range from non-invasive to invasive measurements with central lining. The most invasive method, the pulmonary artery catheter (PAC) has long been considered the optimal form of monitoring cardiac output by using thermodilution. However, this technique is associated with adverse events, such as bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other techniques have been proposed, ranging from systems that use the dilution technique but only require central venous and peripheral artery lines; to less invasive tools that estimate cardiac output based on the arterial pressure waveform; and to non-invasive echocardiography. Despite technical advances, much remains unknown about the value of conventionally used hemodynamic parameters for estimating cardiac output. A distinction between macro- and microcirculatory parameters can be made. Commonly used macro-circulatory parameters are heart rate, systolic and diastolic blood pressure, mean arterial pressure and central venous pressure. Lactate is used as a proxy for microcirculatory status. Over the years several other measurements have been suggested to improve insight in the hemodynamics of a certain patient or a group of patients. Skin temperature, capillary refill, mottling score and urinary output are used for hemodynamic assessment of the peripheral circulation and tissue perfusion. Most of these parameters have not been evaluated in a large prospective study and especially a combination of all these parameters has not directly been correlated to cardiac output. More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac output could assist physicians in earlier detection of impaired hemodynamics without the need for invasive or advanced methods. In this study the investigators aim to evaluate all hemodynamic parameters in a large unselected population of critically ill patients and to correlate them to cardiac output. Purpose: The purpose of this study is to create an infrastructure for a registry flexible to incorporate temporarily added specific research questions on the outcome of critically ill patients.

NCT ID: NCT02899208 Completed - Quality of Life Clinical Trials

Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?

Start date: September 2016
Phase: N/A
Study type: Observational

This study aims to investigate whether an actigraph, measuring in-hospital activity, used for a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical function at three-month follow up. The hospital activity will be measured with actigraphy, a measurement tool that quantifies activity level. The activity will be measured for 7 days after ICU discharge. The actigraph is to be worn as a bracelet. The physical function will be measured with Chelsea Critical Care Physical Assessment Tool (CPAx). CPAx is assessed at ICU discharge and after three months.