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Critical Illness clinical trials

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NCT ID: NCT02920086 Recruiting - Critical Illness Clinical Trials

Improving Partnerships With Family Members of ICU Patients

IMPACT
Start date: May 9, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to improve the outcomes of critically ill older patients and the health outcomes of their families by capacitating and partnering with families in optimizing patient/family centered care.

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: NCT02905812 Recruiting - Delirium Clinical Trials

Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients' Delirium and Related Outcomes

REPOSE
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard care group to assess the feasibility and treatment effect of a multimodal integrative intervention for delirium prevention and associated detrimental effects. Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess feasibility and measures of effect of a multimodal intervention consisting of relaxation with guided imagery (RGI), and moderate pressure massage on physiological and psychological outcomes of critically ill patients. Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment, randomization, adherence, timing of intervention, workload), b) calculate estimates and variance of treatment effect across outcome measures, c) calculate confidence intervals (CI) of incidence proportions, means and standard deviation (SD) of outcome measures in study groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60 participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria: Critical illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria: Patients: a) with expected ICU LOS< 72 hours, b) with acute neurological illness/ trauma, persistent sedation or coma, c) with current history of severe mental health problems and dementia, as per history and psychiatrist assessment, c) with hearing impairment or conditions not permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol withdrawal, g) enrolled in trials of sedatives, antipsychotics. Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a) relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II Andante). Duration of administration: Up to 5 days while participants still in the ICU. Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology: Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals will be presented with estimated effects. Primary analysis will be based on all available data utilizing data from all assessments.

NCT ID: NCT02903407 Terminated - Critical Illness Clinical Trials

Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU

Start date: September 1, 2017
Phase: Phase 4
Study type: Interventional

This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.

NCT ID: NCT02902276 Recruiting - Critically Ill Clinical Trials

Link Between Plasma Citrulline and Lipopolysaccharide Concentrations in the Critically Ill

CITRANS
Start date: July 2016
Phase: N/A
Study type: Observational

In critically ill patients, the small bowel permeability is increased, leading to bacterial translocation, and systemic inflammatory response syndrome. Plasma citrulline is a validated biomarker of functional enterocyte mass. Lipopolysaccharide (LPS) is a part of Gram negative bacteria, and plasma LPS concentration is a biomarker of bacterial translocation. The link between plasma citrulline and LPS in the critically ill is unknown. Investigators hypothesize that patients presenting with low plasma citrulline concentration, with presumed altered small bowel function, would have an increased phenomenon of bacterial translocation, and increased plasma LPS concentration. Investigators aimed to evaluate the link between plasma citrulline and LPS concentrations in critically ill patients at the time of ICU admission.

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.

NCT ID: NCT02897713 Suspended - Critical Illness Clinical Trials

Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

Start date: November 2016
Phase: N/A
Study type: Interventional

Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.

NCT ID: NCT02896218 Recruiting - Critically Ill Clinical Trials

Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

VCMTDMinCI
Start date: October 2016
Phase:
Study type: Observational [Patient Registry]

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

NCT ID: NCT02895659 Completed - Critical Illness Clinical Trials

Fluid Management in Patients Undergoing Cardiac Surgery

Hemacetat
Start date: December 1, 2016
Phase: Phase 4
Study type: Interventional

Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.