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Sepsis clinical trials

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NCT ID: NCT03672006 Completed - Clinical trials for Central Venous Catheter Thrombosis

t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection

TOPCAT
Start date: April 22, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this pilot study is to test feasibility of concept, consent and enrollment rates, and mechanics of study designed to assess if intra-catheter dwells of tissue plasminogen activator (t-PA) is effective in decreasing the rate of clinically diagnosed central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE) in central venous catheters (CVC) compared to standard of care heparin dwell.

NCT ID: NCT03661450 Completed - Sepsis Clinical Trials

Evaluation of CDSS in Detection of SIRS and Sepsis in Pediatric Patients

CADDIE2
Start date: August 1, 2018
Phase:
Study type: Observational

This trial aims to evaluate the accuracy of a Clinical Decision-Support System to support early recognition of SIRS in paediatric intensive care patients. This assessment will be rated by the primary goals, the sensitivity and specificity of the system. Two experienced paediatric intensivists, who are blinded for the CDSS results, will analyse the electronic patient file (EPF) for SIRS criteria and thus establish our Goldstandard. All SIRS events recognized by the CDSS during the patient's stay are taken into account and will be compared with the established Goldstandard. The secondary goal of this trial is to evaluate the CDSS-results with the assessment of SIRS by paediatric doctors during their routine work on the PICU.

NCT ID: NCT03655626 Completed - Sepsis Clinical Trials

Implementation and Evaluations of Sepsis Watch

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording & transcripts, and survey responses) will be stored on HIPAA-compliant Duke servers behind the Duke firewall, and requiring password-protected user authentication to access. The risk to patients is minimal. The two risks to interviewed clinical staff we have identified involve loss of work time and anonymity.

NCT ID: NCT03645668 Completed - Sepsis Clinical Trials

Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

Start date: January 30, 2018
Phase: Phase 4
Study type: Interventional

The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data

NCT ID: NCT03644030 Completed - Sepsis Clinical Trials

Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients

Start date: September 6, 2018
Phase:
Study type: Observational

In general, malnutrition in surgical patients is associated with a higher risk of postoperative infections, decreased immune response, more cardiac complications, prolonged mechanical ventilation , and a higher rate of reimportation due to several other complications than lead to an increase in morbidity and mortality, a prolongation of the total hospitalization time in the ICU[intensive care unit ] and the chamber, and a delay in the healing of the surgical trauma . The presence of a low percentage of lean mass, as calculated by the technique of bioelectric conductivity, practically means a small percentage of muscle tissue. However, muscle tissue is an important, if not the only source of amino acids for both protein synthesis and gluconeogenesis in stress conditions, such as surgery and the first postoperative days. Thus, post-operative patients in general, and cardio-operated patients, in particular, having a low lean mass have minimal reserves to the stress requirements, resulting in an increased risk of complications. In the last few years, the most reliable indicator of malnutrition- in addition to the lean mass index - began to be considered the phase angle, which is also calculated when measuring the bioreduction of electrical conductivity, although there is a very recent challenge . The phase angle expresses the relationship between the electrical reactance, i.e. the state of the cell membrane, to resist the permeability and the resistance, i.e. the restriction to the flow of the electrical current through the body, mainly related to the water of the tissues . Like the FFM[fat-free mass]- index, the phase angle uses the total water of the tissues, and thus also reflects the cell mass. In addition, however, it also measures the resistance of cell membranes, so it also evaluates their quality and is therefore considered to be a reliable indicator of poor nutritional status , although some also maintain demur due to the possible poor distribution of extracellular fluid in cardiological patients. From all of the above, it appears that there are some gaps in the evaluation of the patients who are going to undergo cardiac surgery regarding their nutritional status, both because the classic nutrition control indicators are not fully documented as being reliable for these patients, and there are no studies to monitor and compare body composition directly to any other index postoperatively.

NCT ID: NCT03641534 Completed - Malaria Clinical Trials

Monitoring of Perfusion in Sepsis and Malaria

PERFuSE
Start date: June 4, 2018
Phase:
Study type: Observational

Sepsis and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may exacerbate acute kidney injury. These complications of sepsis and severe malaria significantly increase mortality, particularly in resource-limited settings lacking mechanical ventilation and renal replacement therapy. Point-of-care ultrasound and passive leg raise testing are two easily implementable, safe and non-invasive clinical bedside fluid assessment tools that could be applied towards developing a fluid management algorithm in low resource settings. Similarly, simple tissue perfusion measures can facilitate understanding of precise indications or contraindication to fluid and vasopressor therapy. However, the performance of these tools has yet to be confirmed in these settings. Accurate assessment of pulmonary tolerance and fluid responsive patients could aid to tailor vasopressor and fluid therapy to the patient condition and disease phase, thus preventing or detecting iatrogenic pulmonary edema and other pulmonary complications. As there is currently limited evidence supporting fluid management recommendations for severe malaria and sepsis in low-resource settings, the potential application of these management tools could optimize supportive therapy and improve outcomes in these populations. The main activity proposed is a prospective, observational study of patients with sepsis and severe malaria to describe the relationship between fluid therapy and vasopressor therapy against measures of tissue perfusion and pulmonary congestion in adult patients with severe malaria or severe sepsis. In addition, the study will assess the performance of simple bedside clinical tools assessing fluid responsiveness, pulmonary congestion and peripheral tissue perfusion. The data from this observational study will facilitate the preparation of a follow-up study to test a clinical algorithm to guide individualized fluid and vasopressor administration.

NCT ID: NCT03633500 Completed - Feeding Behavior Clinical Trials

Effectiveness of Oral Immunotherapy Among Preterm Babies

Start date: August 16, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis

NCT ID: NCT03628300 Completed - Sepsis Clinical Trials

Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

NebuLar
Start date: January 1, 2017
Phase:
Study type: Observational

Beta-lactams are the most prescribed antibiotics in intensive care units. The lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. However, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. The main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. Apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. The study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients. This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.

NCT ID: NCT03623503 Completed - Newborn Sepsis Clinical Trials

Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis

IMF-NN
Start date: February 21, 2016
Phase:
Study type: Observational

Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.

NCT ID: NCT03620409 Completed - Sepsis Clinical Trials

Identification of Cardiovascular and Molecular Prognostic Factors for the Mid- and Long-term Outcome of Sepsis

ICROS
Start date: May 9, 2018
Phase:
Study type: Observational

Sepsis is a life-threatening condition which can affect people of any age. An infection triggers a host response resulting in organ failure. The extent of the organ dysfunction varies between patients and during the course of the condition. Thus far, the only causal treatment option consists in treating the infection early e. g. by an operation or the use of antibiotics. Owing to advances in modern critical care, more patients survive sepsis. Nonetheless, sepsis survivors frequently show impaired organ function, physical disability and considerably decreased health-related quality of life. It is hypothesized that sepsis-induced cardiac dysfunction - septic cardiomyopathy - may influence mortality. The relationship between occurrence of cardiovascular dysfunction and metabolic changes in the course of sepsis remains unclear. Therefore, the aim of this study is the investigation of cardiovascular function, oxygen consumption and metabolic changes in septic patients. Apart from cardiological routine procedures (echo- and electrocardiography) a newly developed method for measuring the oxygen tension and consumption, bioelectrical impedance analysis for body composition estimation and liver fibrosis assessment via transient elastography will be employed. Through blood, stool and urine analysis, both routine parameters and parameters focusing on patient metabolism will be analysed. Septic patients will be assessed in the acute phase (3 and 7 days after sepsis diagnosis), the stable phase (at intensive care unit discharge) and after full or incomplete recovery (during two outpatient visits at 6 and 12 months after sepsis diagnosis). The results will be compared with healthy individuals and patients with existing heart disease (cardiomyopathy). The study aims to identify clinical parameters and signaling pathways involved in the development and course of sepsis. Furthermore, specific parameters associated with the medium- and long-term health status, physical performance and quality of life after sepsis are to be identified. The overall aim of the study is the development of novel diagnostic and therapeutic approaches in sepsis.