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Critical Illness clinical trials

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NCT ID: NCT04462393 Active, not recruiting - COVID-19 Clinical Trials

Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19

Start date: March 6, 2020
Phase:
Study type: Observational

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients. Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS BEEN COMPLETED. UPDATE 26 Feb 2022: Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459. A description of the surge response and aggregated data outcomes in Scandinavian countries was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983. ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES Due to the continued influx of patients requiring intensive care throughout 2020 and 2021, we extended the inclusion period to 30 June 2021. Thus this new cohort will include all patients admitted to ICUs in Sweden from 6 March 2020 to 30 June 2021. We will investigate short (30day mortality) and long-term outcomes (365d mortality and cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2 infection and COVID-19 disease.

NCT ID: NCT04462211 Completed - Critical Illness Clinical Trials

Constipation Bundle/Protocol and the Effect of Adherence in the Incidence of Constipation in Critically Ill Patients

motility
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Gastrointestinal abnormalities are present in more than 80% of critical patients, and their management has taken an important importance in intensive care unit (ICU), since it can largely determine the clinical outcome, costs and long-term prognosis in This group of patients. Only the constipation in the critical patient has been related to the failure of weaning of the mechanical ventilator, an increase in mechanical ventilation time, and with the increase of the stay in the ICU. In general, most critical health conditions cause a decrease in the motility of the gastrointestinal tract that intrinsically can contribute to constipation. This is explained by the increase in pro-inflammatory cytokines, increased activity of the sympathetic system, the use of vasopressors, high and prolonged doses of opiates, among others, which can reduce gastric emptying and delay motility. These gastrointestinal abnormalities may be associated with an increase in intra-abdominal pressure, reduced nutritional intake, bacterial hyperproliferation in the digestive tract, intestinal mucosal injury and bacterial translocation through the injured and / or inflamed mucosa. In addition, patients who experience constipation often have gastroparesis and paresis of the ileum, conditions that hinder the progression of nutritional support enterally and worsen the patient's clinical picture. In spite of being quite common in the ICU, the impact is not known in depth, which implies that these alterations are usually not prevented and on the other hand when treating their pharmacological and non-pharmacological management is highly variable because, for a On the other hand, staff turnover (intensivist physician) and on the other hand because there are no protocols that reduce these problems. To provide comprehensive care in critical patient units, according to the best available evidence in order to reduce the variation in daily care, clinical guidelines and protocols are applied to manage the various specific problems that affect this group. of patients One way to address the complexity of these problems is through the implementation of care packages, which have taken relevance in the prevention of characteristic events of high mortality and morbidity. It is in this scenario, where the clinical pharmacist plays an important role in the development of protocols, packages and their compliance. The clinical pharmacist is dedicated to the review of the therapy of each patient, through pharmacological conciliation actions with the attending physician, actively participating in the daily round of the multidisciplinary team and at the same time developing "professional support activities" that include , reviews of adverse events associated with medications, education, auditing, research, development of guidelines and institutional protocols for the use of effective and safe medications, with the objective of reducing mortality and its associated costs, thus improving the quality of the Attention. Given the importance of the problem, it is that this work proposes that the implementation and active dissemination of a constipation bundle/protocol guided by a clinical pharmacist ensures adherence to the strategy in the treatment team and a decrease in the incidence of constipation in the critical patient of the ICU of a university hospital. To fulfill this objective, a quasi-experimental study was designed in which the first stage will be diagnostic observational and a second part of the interventional type, in order to evaluate the effect of adherence to the bundle/protocol on the incidence of constipation in critically ill patients admitted to a ICU of a university hospital for a period of 6 months.

NCT ID: NCT04460625 Completed - Critical Illness Clinical Trials

Effect of Blood Group on the Survival Status of Intensive Care Patients

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

The research was planned to determine the effect of different blood groups on the 90-day survival of intensive care patients who were treated and maintained for the first time in the intensive care unit. The research is a retrospective descriptive research. For the first time in an intensive care unit aged 18 and over, between January 1, 2014 and December 31, 2019, of a state and a university hospital in the Western Black Sea Region, in intensive care units (both medical and surgical patients), All the patients, who were hospitalized in the intensive care unit for at least 24 hours, were discharged from the intensive care unit for 90 days and less, and all the information in the Patient Information Form can be accessed from the automation system. The research will be conducted between 01.04.2020-01.07.2020 by collecting the necessary data within the 'Patient Information Form' of the patients from the information processing unit of the hospitals where the research will be conducted.

NCT ID: NCT04457609 Recruiting - COVID Clinical Trials

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Start date: July 2020
Phase: Phase 1
Study type: Interventional

Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.

NCT ID: NCT04455360 Completed - Depression Clinical Trials

Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial

Cov-EMERALD
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT ID: NCT04455061 Recruiting - Clinical trials for Gut Microbiota, PICS

Intestinal Flora Research Plan for Critically Ill Patients

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

More and more critically ill patients have improved early survival, they have been suffering from organ damage and inflammation for a long time, which is called chronic critical illness (CCI). Among CCI, persistent inflammatory response-immunosuppression-catabolic syndrome (PICS) is a special type of chronic severe disease, and immune paralysis is its main feature. The clinical manifestations are repeated nosocomial infections, malnutrition, muscle loss, and difficulty in wound healing and require long-term emergency medical support, which ultimately leads to patients Repeated nosocomial infections, prolonged hospitalization, and increased mortality. The gut provides the microbiome with habitat and the nutrients it needs, down-regulates the immune response to form immune tolerance, and promotes its colonization in the intestine.Under physiological conditions, the mutually beneficial symbiosis of the intestine and microorganisms promotes the body's homeostasis. The composition and biodiversity of the microbial community are highly susceptible to various factors, including diet, environment, drugs, infections, inflammation, etc. Especially for acute stress, severe stress, the use of broad-spectrum antibiotics, vasoconstrictors and opioids, intestinal ischemia/reperfusion injury, epithelial cell apoptosis, barrier integrity destruction, gastrointestinal Changes in the motility of the tract, lack of nutrients in the intestinal cavity, etc. All those can lead to rapid changes in the intestinal flora, and this change can last for a long time; manifested by the loss of the richness and diversity of the intestinal microflora (especially the symbiotic flora), The ratio of Bacteroidetes/thickwalled bacteria is severely unbalanced, and a single flora (often a potential pathogen) overgrows, that is, bacterial flora imbalance or microecological disturbance. At present, for critically ill patients, there are few relevant studies, and currently limited to small-scale, single cross-sectional studies. These studies have uncovered the changes and impacts of intestinal microbiota in critically ill patients in ICU, but they are still in the stage of touching the image of blind people. The relevant mechanisms and dynamic changes and their significance are unclear, requiring large-scale, dynamic, continuous and comprehensive In order to accurately grasp the role of intestinal flora in the development and prognosis of the disease, we hope to accurately control the intestinal flora and achieve effective treatment.

NCT ID: NCT04454372 Completed - COVID-19 Clinical Trials

Clinical Characteristics and Outcomes of 187 Critically Ill Patients With Coronavirus Disease 2019 (COVID-19)

Start date: July 15, 2020
Phase:
Study type: Observational

This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

NCT ID: NCT04452617 Completed - COVID-19 Clinical Trials

Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19

Start date: March 19, 2020
Phase:
Study type: Observational

Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients. Many raised concerns regarding the potential cardiac toxicity of this association. The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure. The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.

NCT ID: NCT04451889 Recruiting - COVID-19 Clinical Trials

Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients

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

The study is devoted to the comparative analysis of the data received in patients with COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).

NCT ID: NCT04445259 Recruiting - Critical Illness Clinical Trials

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

Start date: June 20, 2020
Phase:
Study type: Observational

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.