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Critical Illness clinical trials

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NCT ID: NCT04698798 Completed - Critical Illness Clinical Trials

Skeletal Muscle Wasting in SARS-CoV-2

SMW
Start date: January 2, 2021
Phase: N/A
Study type: Interventional

The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity. Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.

NCT ID: NCT04694742 Recruiting - ARDS Clinical Trials

Ventilatory Efficiency in Critically Ill COVID-19 Patients

Start date: September 1, 2020
Phase:
Study type: Observational

The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide. Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes. This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.

NCT ID: NCT04693143 Not yet recruiting - Critical Illness Clinical Trials

Timing of Initiation of Parenteral Nutrition for Critically Ill Children

TPN
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Parenteral Nutrition (PN) is prescribed to children with a non functioning gut. Timing of initiation of PN for critically ill children is a hotly issue. Therefore investigators aim to determine the optimal timing of initiation of PN among these children.This is a randomized clinical trial will be conducted at a Pediatric Intensive Care Unit(PICU) in tertiary care hospital. 140 participants will be randomized to receive either early or late PN. The 1st group gives PN on the 1st day of PICU admissions while the 2nd group gives late PN on the 7th day. Under-nutrition children, early PN will start on the 1st day while late PN begins on 4th day of admission. The outcomes are assessment of mechanical ventilation duration, PICU length stay, and mortality.

NCT ID: NCT04690530 Not yet recruiting - Septic Shock Clinical Trials

Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Start date: March 1, 2022
Phase:
Study type: Observational

Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.

NCT ID: NCT04684069 Completed - Critical Illness Clinical Trials

"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Internal jugular, subclavian, or femoral veins are often used for central venous catheter (CVC) placement. Regardless of which vein is preferred, the "Seldinger" technique is used most frequently. The most commonly used method with ultrasound is the short-axis out-of-plane approach. The main problem in this method is that the correct needle tip is missed, and it causes some complications by causing posterior wall punctures. The "Syringe-free" technique is first reported by Matias et al. in adults; it is a technique that allows full real-time monitoring of the guidewire insertion into the vein without blood aspiration. It is a great advantage in CVC placement, especially with the long-axis in-plane approach. When the literature is reviewed, no study other than a 12 case study in which brachiocephalic vein catheterization related to CVC placement was performed using this technique in children was found. There is no randomized study comparing the "Syringe-free" Long-Axis In-Plane technique with the classic Short-Axis Out-of-Plane technique in pediatric patients. This study compares these two techniques' efficacy and complication rates in critically ill children requiring CVC placement.

NCT ID: NCT04676464 Completed - Critical Illness Clinical Trials

VALIDation of Bedside Ultrasound of Muscle Layer Thickness of the Quadriceps in the Critically Ill Patient

VALIDUM
Start date: December 2013
Phase:
Study type: Observational

The overall objective is to evaluate the validity of bedside US of QMLT and MF-BIA by comparing measurements from US and MF-BIA to those estimates of lean body mass obtained from CT Scan of abdomen when done for clinical reasons. The investigators expect to observe a high degree of correlation between these 3 baseline measures and the changes in US measures and MF-BIA over time to correlate with changes to CT Scan measures of lean body mass.

NCT ID: NCT04674657 Recruiting - Critical Illness Clinical Trials

Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients

EAT-PK
Start date: September 3, 2018
Phase:
Study type: Observational

Observational study Primary Objective: To study whether ECMO alters the PK of anti-infectives including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Secondary Objectives: Develop Population PK models of anti-infectives, including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Develop Physiological-Based PK (PBPK) model of anti-infectives, including: voriconazole, posaconazole and caspofungin in critically ill patients on ECMO Study population: Critically ill patients on ECMO Methodology: Observational study to determine whether ECMO alters the PK of anti-infectives, by developing PK models This is a non-interventional descriptive study in that the anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols in line with patient's routine care. Patients will be asked to provide additional blood samples over the course of the anti-infective dosing schedule, these samples will be taken from existing arterial lines to help guide treatment in future patients on ECMO receiving these anti-infectives.

NCT ID: NCT04671160 Not yet recruiting - Clinical trials for Assessment of Activity of Anti-Xa Factor in Patients Treated With Continuous Veno-venous Hemodiafiltration Receiving Anticoagulant Prophylaxis

Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

Start date: January 4, 2021
Phase:
Study type: Observational [Patient Registry]

Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.

NCT ID: NCT04669444 Active, not recruiting - Critical Illness Clinical Trials

Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

IGNITE
Start date: April 14, 2020
Phase: N/A
Study type: Interventional

Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.

NCT ID: NCT04666948 Active, not recruiting - Vancomycin Clinical Trials

Precision Dosing of Vancomycin in Critically Ill Children

BENEFICIAL
Start date: December 28, 2020
Phase: Phase 4
Study type: Interventional

The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.