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Toxemia clinical trials

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NCT ID: NCT03201679 Completed - Sepsis Clinical Trials

The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery

Start date: January 1, 2014
Phase:
Study type: Observational

The worldwide occurrence of hip fracture is high with an annual incidence of approximately 100 per 100.000 people. Mortality for patients undergoing hip fracture surgery is high with a 30-day mortality rate varying between 4.5 and 13.3 %. It is agreed that non-modifiable factors such as age, gender and pre-existing comorbidities contribute to early death of hip fracture patients. However, not many studies have focused on preoperative sepsis as a potential risk factor. Hip fracture patients are commonly identified with sepsis after surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated. Being able to identify patients at higher risk of postoperative mortality could potentially improve outcome and extensive hospital registries of vital signs and cultures allow identification of preoperative sepsis. The aim of this study is to assess the association between preoperative sepsis and the 30-day mortality after hip fracture surgery.

NCT ID: NCT03199547 Completed - Neonatal SEPSIS Clinical Trials

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

PregnAnZI-2
Start date: October 21, 2017
Phase: Phase 3
Study type: Interventional

Though maternal and neonatal health are high priority areas for international development, maternal and neonatal mortality remain unacceptably high. Worldwide there are 1 million maternal and 4 million neonatal deaths every year and half of them occur in sub-Saharan Africa. Post-partum and neonatal severe bacterial infections, namely sepsis, are leading causes of maternal and neonatal deaths in sub-Saharan Africa. Newborns can be infected during labour - when passing through the birth canal - and also during the first days/weeks of life, as a consequence of the close physical contact with the mother, when the latter carriers bacteria. As the mother is an important source of bacterial transmission to the newborn, treating mothers with antibiotics during labour should decrease their bacterial carriage and therefore lower transmission to the newborn. As carriage is a necessary step towards severe disease, this intervention should in turn result in the lower occurrence of severe bacterial disease and mortality during the neonatal period. In many high-income countries, pregnant women are screened during pregnancy for vaginal carriage of Group B Streptococcus, the bacteria responsible for the vast majority of neonatal sepsis in the developed world. If women are carriers, they are treated with intravenous antibiotics during labour to decrease the risk of severe disease to their off-spring. Although this intervention has been successful in developed countries, infrastructure and resource limitations in regions like sub-Saharan Africa prevent both screening and use of intravenous antibiotics. Also, in Africa several bacterial pathogens are responsible for neonatal sepsis and the antibiotics needed in the continent should cover a wider number of bacteria; and ideally cover also bacteria responsible for severe post-partum disease in the mother. We will conduct a large trial in West Africa, The Gambia and Burkina Faso, with the main objective of determining if a single dose of an oral antibiotic given to women during labour decreases newborn mortality. The trial will also assess the effect of the antibiotic on lowering newborns and maternal hospitalization during the first week's post-partum. We have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already been used for elimination of other prevalent diseases such as trachoma. This antibiotic is safe, requires a single oral administration, has no special storage requirements and has the potential to eliminate most of the bacteria commonly causing severe disease in newborns and post-partum women in the continent. Very important this antibiotic is not widely used in clinical care in the continent, and therefore, any temporal increase of resistance induced by the intervention should not have implications on current treatment guidelines. Before going to the large trial proposed here (12,000 women to be recruited), we have generated robust preliminary data on the effect of the intervention in a proof-of-concept trial conducted in The Gambia (829 women and their offspring recruited). We found that in fact, babies born from mothers who had taken this antibiotic during labour were less likely to carry bacteria that can potentially cause severe disease. These babies were also three times less likely to have bacterial skin infections or umbilical infections, both highly common among African newborns. Besides, fever or mastitis (again both very common in the region) during the post-partum period were four times lower among mothers who had taken the antibiotic during labour. Such trial confirmed our hypothesis of impact on bacterial transmission but it was too small to assess the effect of the antibiotic on mortality and hospitalizations. The preliminary trial also showed that women from the azithromycin group were less likely to need antibiotics for treatment infections during the puerperal period, decreasing then the pressure on the scarcity of antibiotics available in the continent. The advantages of our approach are its simplicity, low cost and the possibility of protecting both mothers and babies with the same intervention.

NCT ID: NCT03179189 Recruiting - Sepsis Clinical Trials

Investigation of The Prevalence of Sepsis in Adults in Multicenter Intensive Care Unıts in Turkey

Start date: October 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The pathophysiology and treatment of sepsis disease are still not fully known. International guides often refer to the studies done in the developed countries and suggest some treatments. The infrastructure of the developing countries is quite different. For this reason, it is not exactly scientific how much these proposals are reflected in patient treatment. In our study, We will try to reveal the treatment of sepsis.

NCT ID: NCT03175328 Recruiting - RTT Clinical Trials

CRRT Timing in Sepsis-associated AKI in ICU

CRTSAKI
Start date: August 22, 2019
Phase: N/A
Study type: Interventional

Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application of extracorporeal renal replacement therapies (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial. It is reported that a correlation was observed between the concentrations of circulating inflammatory cytokines and mortality in patients with septic shock. Therefore, it is hypothesis that adequate removal of inflammatory mediators from the circulation may provide a potential therapy for this devastating condition. Indeed, data from meta-analyses, observational studies and randomized controlled trial (RCT) suggests that initiating RRT in critical ill patients (including patients with sepsis and non-sepsis) at early stage may be beneficial. But in some studies, initiating RRT at early stage do not shown to improve survival compared with initiating RRT at late stage. At present, large-scale prospective RCT about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is not merely academic but may impact on outcomes. Therefore, in our study, 460 patients with SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be divided into early group and delayed group randomly. In the early group, continuous RRT (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization. Overall survival at day 90 will be observed in order to understand whether different CRRT strategy would affect the outcomes of SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve outcomes of SAKI.

NCT ID: NCT03158493 Completed - Sepsis Clinical Trials

Assessment of qSOFA in the Latin America Sepsis Institute Database

Start date: May 2016
Phase: N/A
Study type: Observational [Patient Registry]

Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a fairly robust analysis of large, essentially American, databases. In addition to the new definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver operator characteristics (ROC) curves suggest an adequate predictive validity for the new score, a lot of controversy around its sensitivity as a screening tool mainly in settings with high mortality rates. Current national Brazilian data show that sepsis mortality in our country, especially in public hospitals from the Unified Health System (SUS), is very high and well above world mortality. The impact of using the qSOFA in these settings is not known. In this context, the present study aims to evaluate the potential impact of using qSOFA as a screening tool in Brazilian private and public institutions. The hypothesis is that the use of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The hypothesis was also that those patients with a qSOFA negative will have a high mortality rate, mainly in Brazilian public hospitals.

NCT ID: NCT03152474 Completed - Sepsis Clinical Trials

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

Start date: February 1993
Phase: Phase 4
Study type: Interventional

The study involves the participant to receive a 250 mcg Cortrosyn (ACTH) Stimulation Test to test the ability of the body to make Cortisol. If the body is not able to make large amount of Cortisol (Delta Cortisol < 13 mg/dl) from the stimulation test, then the participant will be given additional cortisol like medicine called Solumedrol or matching placebo. If the body is able to make large amounts of Cortisol (> 13 mg/dl), then the participant will receive daily shots of Vitamin A for 7 days or matching placebo. If the participant does not respond to the stimulation test, and meets the criteria for Cortisol deficiency (all 3 cortisol concentrations < 20 mg/dl), then he/she will screen failed for the study and will be offered hydrocortisone as part of routine care by the treating physician.

NCT ID: NCT03146546 Enrolling by invitation - Sepsis Clinical Trials

STUDY00015328: Sepsis Endotypes

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

Determine the utility of blood resistin concentrations, when combined with clinical data, for predicting sepsis phenotypes that are associated with poor clinical outcomes. We hypothesize that resistin is a biomarker which provides critical prognostic information when used in conjunction with standard clinical data, in patients with sepsis and septic shock.

NCT ID: NCT03145428 Completed - Sepsis Clinical Trials

Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

MDW
Start date: June 19, 2017
Phase:
Study type: Observational

The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.

NCT ID: NCT03141112 Enrolling by invitation - Severe Sepsis Clinical Trials

The Benefits of Early Initiation of Continual Renal Replacement Therapy in Patients With Severe Sepsis

Start date: August 2016
Phase: N/A
Study type: Observational

The study will evaluate the benefit of early initiation of CRRT in the initial phase of severe sepsis in patients admitted to the ICU. Primary evaluated end-point is 28-day mortality. Secondarily evaluated end-point is length of ICU-stay, length of stay in hospital, duration of mechanical ventilation. There are two groups. One group of participants with early CRRT initiation and another group with late CRRT initiation. Reference group no CRRT.

NCT ID: NCT03137446 Completed - Septic Shock Clinical Trials

Restrictive Intravenous Fluids Trial in Sepsis

RIFTS
Start date: April 20, 2017
Phase: N/A
Study type: Interventional

IV fluid resuscitation has long been recognized to be an important treatment for patients with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no standard of care and a lack of evidence to support a fluid restrictive or more liberal strategy. The investigators seek to determine if a fluid restrictive strategy reduces morbidity and mortality among patients with severe sepsis and septic shock.