There are 20 clinical trials

Clinical Trials

1 ICG Fluorescence Imaging in Trauma Patients

This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion.

NCT04245111 Trauma Injury Other: Immunofluorescence Imaging

MeSH:Wounds and Injuries

2 Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study

The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.

NCT04316299 COVID-19 Acute Kidney Injury Kidney Function

MeSH:Acute Kidney Injury Wounds and Injuries

HPO:Acute kidney injury

3 The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.

NCT04340479 COVID Trauma Ultrasound Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation

MeSH:Wounds and Injuries

4 Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19

The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.

NCT04341038 COVID-19 Lung Injury Drug: Tacrolimus Drug: Methylprednisolone

MeSH:Lung Injury Wounds and Injuries

5 Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

This research study is an extension on a study already preregistered NCT04209283 and is designed to investigate the use of a simple cognitive task (a memory cue followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. This is a single case series using a within subject multiple baseline AB design. Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue using the technique self-guided in subsequent weeks. Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase and that the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, the investigators will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.

NCT04342416 Trauma Behavioral: Visiospatial Interference

MeSH:Wounds and Injuries

6 Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (EVICT-CORONA-ALI)

This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.

NCT04344184 COVID-19 Lung Injury, Acute Drug: L-ascorbic acid Other: Placebo

MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

7 Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors

Coronavirus disease was first diagnosed in December 2019, in the city of Wuhan, China. The World Health Organization recently declared coronavirus disease 2019 (COVID-19) as a pandemic. The infection is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a single-stranded RNA virus, which in humans causes mild respiratory symptoms and generally has a good prognosis. However, in a certain group of patients it manifests as severe pneumonia, respiratory distress syndrome, multiple organ dysfunction and death. The factors associated with a worse prognosis are older than 60 years, the presence of diabetes, cardiovascular disease and obesity. According to studies carried out in the Eastern world, the prevalence of liver injury in patients with COVID-19 disease varies between 14% and 53%, being more prevalent in patients with severe symptoms of COVID-19 disease. It is not really known whether the liver involvement of patients with SARS-CoV-2 infection is secondary to the direct effect of the virus on the liver. One of the mechanisms of action of SARS-CoV-2 is through the binding to the angiotensin-converting enzyme receptor, which is present in cholangiocytes, this could explain its excretion in faeces. However, liver injury could be due to the immune response generated in the body by the virus with systemic inflammatory response syndrome and the release of inflammatory cytokines such as IL6, generating direct cytopathic damage to the liver. On the other hand, it could be the product of hepatotoxic drugs administered during hospitalization, such as antibiotics, antivirals or non-steroidal anti-inflammatory drugs. Liver biopsy described microvacuolar steatosis, and a mild portal and lobular inflammatory infiltrate . Therefore, the aim this study is to assess the prevalence of liver complications (liver injury, decompensation of cirrhosis) in patients diagnosed with COVID-19 in Latin America. As secondary objectives, the investigators will describe the clinical characteristics of COVID-19 disease and identify risk factors associated with poor prognosis,

NCT04358380 Liver Injury Other: Liver injury

MeSH:Wounds and Injuries

8 Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

NCT04386564 COVID-19 Kidney Injury Diagnostic Test: mRNA in urine test

MeSH:Wounds and Injuries

9 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Test of Replication to a New Population

This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394156 Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma, Psychological Trauma and Stressor Related Disorders Mental Disorder Behavioral: Brief cognitive intervention

MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Disorders Psychological Trauma Trauma and Stressor Related Disorders Wounds and Injuries

10 Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury

Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19

NCT04397510 Covid-19 ARDS, Human Acute Lung Injury Drug: Heparin Drug: 0.9% Sodium-chloride

MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

11 Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19

The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between high-sensitivity troponin I (TnI) levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

NCT04397939 COVID-19 Myocardial Reperfusion Injury Cardiovascular Diseases

MeSH:Reperfusion Injury Myocardial Reperfusion Injury Wounds and Injuries Cardiovascular Diseases

HPO:Abnormality of the cardiovascular system

12 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

NCT04402957 COVID Severe Acute Respiratory Syndrome Sars-CoV2 Acute Kidney Injury Drug: LSALT peptide Drug: Placebo

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries

HPO:Acute kidney injury

13 Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients. The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.

NCT04406688 Acute Kidney Injury COVID-19 ARDS

MeSH:Acute Kidney Injury Wounds and Injuries

HPO:Acute kidney injury

14 A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID 19 Pneumonia and Acute Lung Injury

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT, for the treatment of patients with COVID-19 pneumonia who have mild to moderate ARDS. LIGHT is a cytokine in the TNF super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.

NCT04412057 COVID-19 Pneumonia Acute Lung Injury ARDS Drug: CERC-002 Drug: Placebo

MeSH:Pneumonia Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

HPO:Pneumonia

15 Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic

Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. PwSCI frequently require supports and services to be able to live independently within the community. These services and supports are sometimes difficult to access within the community when the country is operating under regular capacity, in current times with the global COVID-19 pandemic, the challenges for obtaining and accessing supports and services will become much greater. The proposed project aims to identify the specific needs during this time of crisis and to provide referrals and resources to ameliorate those needs by surveying PwSCI in the St. Louis region. The project also hopes to determine if these persons experience isolation during shelter at home orders. PwSCI, who the investigators serve or have served in the past, will be contacted via phone or e-mail once a month for six months and asked to complete a questionnaire that will allow the investigators to track the participant's needs during the COVID-19 pandemic.

NCT04422769 Spinal Cord Injuries

MeSH:Spinal Cord Injuries Wounds and Injuries

16 COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

NCT04426071 Brain Injuries Stroke Spinal Cord Injuries

MeSH:Brain Injuries Spinal Cord Injuries Wounds and Injuries

17 A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in COVID-19 subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

NCT04445220 COVID-19 Acute Kidney Injury Biological: SBI-101

MeSH:Acute Kidney Injury Wounds and Injuries

HPO:Acute kidney injury

18 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.

NCT04445259 COVID Acute Kidney Injury Critical Illness

MeSH:Acute Kidney Injury Critical Illness Wounds and Injuries

HPO:Acute kidney injury

19 Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm". The aims of this study are: 1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU 2. To identify specific risk factors for AKI 3. To explore pathophysiologic mechanism of AKI during COVID-19 infection

NCT04459975 on Occurrence of Acurate Kidney Injury During Intensive Care Unit Abnormalities of Urinary Analysis Other: Non interventional study

MeSH:Acute Kidney Injury Wounds and Injuries

HPO:Acute kidney injury

20 SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.

NCT04466306 Acute Kidney Injury COVID

MeSH:Acute Kidney Injury Wounds and Injuries

HPO:Acute kidney injury

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