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Toxemia clinical trials

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NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01426711 Completed - Sepsis Clinical Trials

Critical Care Excellence in Sepsis and Trauma

CREST
Start date: September 2009
Phase:
Study type: Observational

The care of patients with sepsis and trauma requires the delivery of appropriate definitive care in the early stages of the illness. Hospitals with limited resources, those in rural and underserved areas of South Carolina, may be unable to consistently provide optimal care to these patients. In addition, the shortage of specialists nationally makes it more difficult for these hospitals to recruit and retain the specialists needed. Patients in these areas continue to pay the rural penalty of poorer outcomes. This study provides specialists' level care through telemedicine consults to rural emergency departments in rural areas of SC to improve outcomes for these patients. The CREST study is a project that specifically addresses the need to bring health care to rural communities in SC, as well as evaluates methods and tests technology to implement this care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural community hospitals to provide rural community physicians care from specialists for trauma and sepsis, which are both high acuity, difficult to treat conditions. CREST is a multi-site trial of telemedicine services to meet rural patients' and providers' need for expert evaluation and management of sepsis and trauma. The specific aims of CREST are: 1. To test the hypothesis that a telemedicine program including education and clinical consultation between a tertiary care academic medical center and rural, local hospitals will significantly improve key treatment decisions and outcome measures in sepsis and trauma. 2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma and sepsis patients exposed to telemedicine intervention and those without the intervention matched on propensity scores are not due to unmeasured confounders. CREST seeks new solutions to rural health disparities, to advance technology, create and retain jobs and address important research opportunities by combining implementation of a novel, trans disciplinary clinical program with rigorous, mixed methods scientific evaluation including clinical, process, and economic outcome measures. The impact on both science and quality healthcare outcomes is broad and CREST has far reaching implications for addressing rural health disparities for acute, life-threatening illnesses.

NCT ID: NCT01411670 Completed - Sepsis Clinical Trials

Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.

Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.

NCT ID: NCT01410578 Completed - Sepsis Clinical Trials

The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO

Start date: September 2009
Phase: N/A
Study type: Observational

The investigators enrolled 144 subjects admitted to ICUs: 60 patients with systemic inflammatory response syndrome (SIRS) and 84 patients with sepsis. Tests for serum sTREM-1, PCT, and CRP levels and blood culture were performed on the day of admission and with the occurrence of FUO (>38.3ºC) during hospitalization. Based on the results of blood culture, the subjects were divided into bacteremia (33 patients) and non-bacteremia groups (51 patients). Based on 28-day survival, bacteremia patients were also divided into survivor (22 patients) and non-survivor groups (11 patients). Serum sTREM-1 and PCT levels were summarized as medians (interquartile ranges) and CRP levels were presented as means ± standard deviations. To explore the early diagnostic value of soluble triggering receptor expressed on myeloid cells 1 (sTREM-1), procalcitonin (PCT), and C-reactive protein (CRP) serum levels for identification of sepsis and bacteremia and the prognosis among patients with a fever of unknown origin (FUO) in the intensive care unit (ICU) and to discuss the clinical application of the results.

NCT ID: NCT01410526 Completed - Abdominal Sepsis Clinical Trials

Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)

Start date: May 2011
Phase:
Study type: Observational

Protocol Synopsis Protocol title: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis managed by laparostomy and VAC Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis Design: Prospective, single-center study Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle line incision>15cm). The study is estimated up to 2 year to enroll Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient discharged or deceased. Endpoints: 1. To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis. 2. To correlate the cytokines levels in the abdominal cavity and the serum plasma. 3. To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity. 4. To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis. 5. To assess the microbial load in the abdominal cavity in patients with severe sepsis. 6. To assess the biofilm formation in VAC polyurethane sponge.

NCT ID: NCT01403935 Completed - Severe Sepsis Clinical Trials

Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

SIR
Start date: December 2007
Phase:
Study type: Observational

The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

NCT ID: NCT01392508 Completed - Sepsis Clinical Trials

IMproved PREdiction of Severe Sepsis in the Emergency Department

IMPRESSED
Start date: March 2011
Phase: N/A
Study type: Observational

The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.

NCT ID: NCT01388725 Completed - Sepsis Clinical Trials

Comparison the Value of Several Biomarkers of Sepsis

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

NCT ID: NCT01378169 Completed - Sepsis Clinical Trials

SIRS and Bacterial Sepsis Discrimination by Biomarkers in ICU

Captain
Start date: January 1, 2011
Phase: N/A
Study type: Observational

Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes. Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.

NCT ID: NCT01352182 Completed - Septic Shock Clinical Trials

Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to determine the effect on inflammatory biomarkers for pioglitazone in patients with severe sepsis and septic shock.