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Critical Illness clinical trials

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NCT ID: NCT03456323 Active, not recruiting - Critical Illness Clinical Trials

Post-ICU Palliative Care Intervention (PIPCI) Trial

Start date: March 20, 2018
Phase: N/A
Study type: Interventional

This is a single center, pilot, randomized, single-blind, usual care controlled, pragmatic clinical trial of a post-ICU palliative care consultation intervention in older (age ≥50 years) survivors of acute respiratory failure. Aim 1: To conduct a pilot post-ICU palliative care consultation intervention trial among frail older ICU survivors and their surrogates. Hypothesis:The Investigators can achieve an adequate enrollment rate, protocol adherence, and intervention fidelity. Aim 2: To estimate effect sizes and variability for changes in symptoms at hospital discharge and 1 month, and to estimate hospice referral rates and acute-care readmission rates at 1 and 3 months. Hypothesis: Effect sizes and feasibility data will inform and support future post-ICU palliative care studies focused on improving ICU survivorship. Exploratory Aim. To assess the use of methylphenidate that is recommended and dosed by the palliative care physician for the treatment of moderate-to-severe fatigue. Hypothesis: (1) Not all patients with moderate-to-severe fatigue will be recommended for methylphenidate therapy. (2) Patients prescribed methylphenidate for treatment of moderate-to-severe fatigue after critical illness will adhere to methylphenidate therapy.

NCT ID: NCT03451968 Active, not recruiting - Clinical trials for Metabolism and Nutrition Disorder

Amino Acid Metabolism in Fed Surgical Critically Ill Patients

Start date: December 2, 2018
Phase: N/A
Study type: Interventional

Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass, strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and is usually observed as a normal part of aging or in certain diseases and pathogenic processes. Major associated factors causing development of sarcopenia may be summarized as interactions of environmental and hormonal factors, underlying diseases, activation of inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of neuromuscular junctions. Intensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy, is a diagnosis that becomes more common as survival rates from long ICU hospitalization are more prevalent. It is characterized by a primary axonal degeneration, without demyelination, that typically affects motor nerves more than sensory nerves. ICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern. Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning from mechanical ventilation. The pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial. Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has been associated with other adverse events). Sodium channels channelopathy is also a researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden condition and lack of mobility, increase in ubiquitination and inadequate protein administration associated with large negative nitrogen balance. In addition mechanical ventilation contributes greatly to this problem. This has been particularly relevant in post trauma/surgical long stayer patients. In the past years great progress was made in the investigation of protein balance, breakdown and synthesis using stable isotope tracers in various medical conditions. In a research performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope were used intravenously without any safety issue problem. Another study was performed on adults suffering from COPD with matched healthy adults, using stable isotopes of phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes were given parenterally as well as enterally. The study showed significant change in splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients. Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and the conclusion was that alterations are present in BCAA metabolism despite normal plasma levels in normal weight COPD. Further research is needed to find a way to compensate for it. These studies and other recent studies (9-19) show us the safety regarding the use of stable isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of amino acid in all sorts of pathological states. Hypothesis & Aim of the study We think that based on current literature, there are important differences between critically ill patients and healthy population in the amino acid profile and distribution in the body as well as synthesis and breakdown. The aim of the study is to measure these differences in long ICU stayers (above 7 days) admitted in the ICU after surgical/trauma injury, and to try and help aiming future treatment and research in this field.

NCT ID: NCT03413189 Active, not recruiting - Critical Illness Clinical Trials

The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness

PREDICTABLE
Start date: March 9, 2018
Phase:
Study type: Observational

Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. The objectives are to determine if there is a link between the amount of exercise performed in intensive care on the presence of delirium, long term cognition and disability whilst ensuring that patient reported outcomes correlate with actual measured results, and to obtain information on recovery from patients and/or relatives to determine themes.

NCT ID: NCT03347656 Active, not recruiting - Critical Illness Clinical Trials

Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients

Start date: October 12, 2017
Phase:
Study type: Observational

The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. The investigators hypothesize that patients' mobilization dose in the intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length of stay (LOS).

NCT ID: NCT03311984 Active, not recruiting - Critically Ill Clinical Trials

Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China

Start date: August 15, 2017
Phase: N/A
Study type: Observational

Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite receiving of a standard dose of Low-molecular-weight Heparin(LMWH), many patients still develop life-threatening embolism. The purpose of this study is to evaluate the anti-Xa levels of different dosing regimens of LMWH in critically ill patients in China.

NCT ID: NCT03268967 Active, not recruiting - Critical Illness Clinical Trials

Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)

Start date: April 1, 2014
Phase: N/A
Study type: Interventional

Admission to the intensive care unit (ICU) is vital for surviving critical illness. An admission to ICU without having a consistent structure, structured review of the patient and a solid team organization lead to unclear communication and responsibility. Factors that correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was that a structured admission can improve patients safety, reduce delays in treatment, reduce ICU length of stay, and improve mortality rate. The overall objective was to optimize patient safety, and effectively use available resources to reduce admission time, delays in treatment and procedures and mortality by using both quantitative and qualitative methods.

NCT ID: NCT03218280 Active, not recruiting - Oxidative Stress Clinical Trials

Oxidative Stress Expression and Metabolic Imbalance in Critically Ill Polytrauma Patients and the Implications of Antioxidant Therapy on Clinical Outcomes

OSPOL
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Critically ill polytrauma patients have a number of physiological disorders secondary to trauma, such as systemic inflammatory response (SIRS), adult respiratory distress syndrome (ARDS), sepsis, oxidative stress (OS), and finally the multiple organ dysfunction syndrome (MODS). Another important aspect in terms of clinical outcome is the energy-metabolic status. Numerous studies have shown that implementing antioxidant therapy, capable of reducing the expression of pro-oxidative, pro-inflammatory and energetic-metabolic status, the mortality rate in critical patients decreases statistically significant. In this research paper, will be implemented a multimodal monitoring protocol that covers the use of biochemical, genetics and epigenetics biomarkers and the use of non-invasive medical devices to assess and monitor critical polytrauma patient. Also will be optimized the antioxidant treatment plan according to the needs of each patient.

NCT ID: NCT03182335 Active, not recruiting - Critical Illness Clinical Trials

Vasopressor SAT Study

Start date: April 28, 2014
Phase:
Study type: Observational

To assess the impact of daily awakening from sedation on the amount of vasoactive medication required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug required to maintain an adequate mean arterial blood pressure will be reduced during a daily awakening from sedation.

NCT ID: NCT03160222 Active, not recruiting - Body Composition Clinical Trials

Validation of Bedside Ultrasound to Predict Body Composition in Non- and Critically Ill Patients

USVALID
Start date: January 2017
Phase: N/A
Study type: Interventional

The prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (CT) scan including the L3 level for any clinical reason. Ultrasound scans of the anterior thighs and forearms will be taken after the CT scan within 48 hours. Bioelectrical impedance analysis (BIA) will also be performed. In addition muscle strength, mobility, physical function and nutrition will be assessed. Primary outcome is the prediction of CT-based whole body muscle and fat volume and BIA-based fat and lean body mass from ultrasound-based muscle and fat thickness. Other secondary outcomes include the intra- and interrater reliability of the CT evaluation and ultrasound examination of muscle and fat mass. The relationship between clinical aspects (strength, mobility, physical function, nutrition) and whole body composition is another secondary outcome.

NCT ID: NCT03115840 Active, not recruiting - Sepsis Clinical Trials

Measuring Outcomes of Activity in Intensive Care

MOSAIC
Start date: March 27, 2017
Phase:
Study type: Observational

Millions of older adults are hospitalized for a critical illness each year and although they are more likely than ever to survive this illness, they commonly face significant morbidity in the form of disabilities in basic self-care activities and in mobility in the months and years afterwards. A better understanding of the underlying risk factors for disability following critical illness is greatly needed, including the effect that activity during hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between activity (measured more rigorously than in prior investigations) and disability, physical function, and cognitive function in survivors of critical illness 3 and 12 months after ICU discharge.