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Shock, Septic clinical trials

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NCT ID: NCT01797978 Recruiting - Septic Shock Clinical Trials

Methylene Blue in Severe Sepsis and Septic Shock

Start date: February 2013
Phase: Phase 3
Study type: Interventional

This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.

NCT ID: NCT01790620 Completed - Sepsis Clinical Trials

Impact of CVVHD With Adsorption Capacity Membranes in Septic Acute Kidney Injury

Start date: May 2013
Phase: N/A
Study type: Interventional

Septic patients with acute kidney injury (SA-AKI) requiring continuous renal replacement therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with continuous venovenous hemofiltration (CVVH) presents frequent complications, known as "dialytrauma", and a high resource cost both technical and human. The study primary end-point is to demonstrate a longer filter life with the use of continuous venovenous hemodialysis (CVVHD) respect to CVVH, both modalities employing the same adsorption capacity membrane. As secondary end-points investigators will try to demonstrate less dialytrauma events of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a proof of concept exploratory trial that will include those patients whom present SA-AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure plasmatic elimination capacity of main cytokines, and other clinical and prognostic relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse effects related to CRRT ("dialytrauma") will also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a minor complication rate (longer filter patency with less dialytrauma events) with a similar immunomodulating capacity and with its consequent lower cost, should settle the based evidence principles that recommend the use of CVVHD asociated to an adsorption capacity membrane in patients with SA-AKI whom need CRRT.

NCT ID: NCT01784159 Terminated - Sepsis Clinical Trials

ASpirin for Patients With SEPsis and SeptIc Shock

ASP-SEPSIS
Start date: March 27, 2019
Phase: Phase 2
Study type: Interventional

This Randomized, pragmatic, multicentric with blinding of patients and health professionals, intention-to-treat analysis has by primary endpoint to evaluate whether the aspirin use reduces the intensity of organic dysfunction measured by the variation of the SOFA score starting from the day of admission to the seventh day. Secundary endpoint: To evaluate if the aspirin use reduces the time of mechanical ventilation, length of stay in the ICU and in the hospital. In addition, to evaluate the safety of its administration regarding the occurrence of bleeding. The data will be collected directly from the chart of the patients admitted to the ICU. Data quality assurance will be made through periodic verification, aiming for complete and consistent data. The centers will receive periodic reports for adequacy of potentially inconsistent or incomplete data. The baseline SOFA of patients with sepsis is 8.8 with a standard deviation of 3. The expected reduction in the control group in the SOFA at day 7 is 2 points. Considering a power of 80% and a level of significance of 0.05, it is estimated that 109 patients will be needed in each group. A total of 218 patients will compose the sample. All analyzes will follow the intention-to-treat principle. We will evaluate the effect of aspirin compared to placebo on primary and binary outcomes by means of relative risks, 95% confidence intervals and chi-square tests. For continuous outcomes with normal distribution, we will present the mean difference, 95% confidence interval and P value calculated by t test. For continuous outcomes with asymmetric distribution, we will perform Wilcoxon test.

NCT ID: NCT01780129 Not yet recruiting - Shock, Septic Clinical Trials

Polydatin Injectable (HW6) for Shock Treatment

PIST
Start date: February 2013
Phase: Phase 2
Study type: Interventional

HW6 can prolong animal's survival time and increase the survival rate. HW6 enhances cardiac function, improves microcirculation, and increases blood pressure and pulse pressure, and improves blood perfusion of important organs; HW6's anti-shock activity comes from a combined multiple target pharmacological effects. Based on a completed phase II trial conducted in China, HW6 can effectively treatment shock patient. This is a phase II clinical study to further evaluate the efficacy and safety of Polydatin Injectable 100mg/5mL/via (HW6) in the treatment of shock in the United States. Patients with traumatic/hemorrhagic shock or septic shock admitted to the emergency room or ICU with systolic blood pressure < 90mmHg, or is on vasopressor(s) for systolic blood pressure stabilization, regardless the types of completed, on-going, or projected Standard of Care or surgery will be recruited to participant in the trial. A total of 120 patients with traumatic/hemorrhagic shock and 120 patients with septic shock will be enrolled. For each type of shock, sixty patients each will be in test group and control group. Both adult males and females aged 18-80 years are eligible. The primary clinical endpoint is the time length (TL) between the start of HW6 administration to the onset of the first treatment success, that is: the systolic blood pressure is stabilized at ≥90mmHg and MAP≥65mmHg for 1 hour without the use of vasopressors. Several secondary endpoints and biomarkers will be measured. Efficacy data will be compared using group t-test or Wilcoxon log-rank test between treatment groups and placebo groups. Safety data will also be reported accordingly.

NCT ID: NCT01775956 Recruiting - Septic Shock Clinical Trials

A Retrospective Review of a Comprehensive Cohort of Septic Shock: Assessment of Critical Determinants of Outcome

Start date: December 2003
Phase: N/A
Study type: Observational

Septic shock remains the dominant cause of death in ICU's of the developed world with approximately 400,000 cases annually in the US and another 20,000 annually in Canada. While many retrospective and prospective reviews of septic shock patients have been undertaken worldwide, many key questions remain unanswered. These questions include the true incidence, associated morbidity and mortality of septic shock in North America, key factors associated with successful management and markers suggesting a high probability of a complicated clinical course. Part of the reason for the persistence of these questions, is the fact that previous and ongoing reviews of septic shock and severe sepsis have been either limited in number (typically <150) or biased by the need to be eligible for specific clinical trials (typically, non-eligible patients have not been followed and had data collected. We propose to examine specific questions within a temporally comprehensive cohort of septic shock patients by review of individual charts using a defined data-extraction template.

NCT ID: NCT01770457 Recruiting - Septic Shock Clinical Trials

Cytokine Response in Septic Shock

Start date: April 2006
Phase: N/A
Study type: Observational

This study is designed to examine the early sequential cytokine responses during antibiotic therapy and resuscitation of septic shock in relation to clinical manifestations of disease. The specific objective is to obtain sequential serum samples from patients with septic shock, examine a broad range of cytokine responses (TNF, IL-1, IL-6, MIF, LIF, HMGB1, etc) in a rigorous manner and correlate these responses to administration of antibiotics, resuscitative efforts and physiologic responses to illness (temp, HR, blood pressure, WBC, etc).

NCT ID: NCT01747187 Recruiting - Septic Shock Clinical Trials

Cardiac Stress in Septic Shock - Biomarkers, Echocardiography and Outcome

Septic Heart
Start date: October 2012
Phase: N/A
Study type: Observational

Septic shock is a major cause of death in intensive care. Septic shock is often dominated by profound changes in organ functions, of which cardiac failure is one of the most severe. In septic shock, biological markers of cardiac stress are often elevated. It is not known to what extent this indicates structural damage to the heart, or in what way they correlate to echocardiographic signs of heart failure. Here, cardiac failure in ICU patients with septic shock is studied, using biological markers of cardiac stress, inflammatory parameters and echocardiography. Investigators hypothesize that biomarkers of cardiac stress correlate with echocardiographic signs of heart failure, and that they can predict an increased risk of death.

NCT ID: NCT01724463 Recruiting - Sepsis Clinical Trials

Electronic Application of a Severe Sepsis Screening Tool and Management Bundle

eASSIST-M
Start date: March 2013
Phase: N/A
Study type: Observational

Thousands of children die from Sepsis following routine infections. Many of these deaths can be prevented with earlier recognition and focused management. No tools are currently available to recognize the signs of early sepsis in children. The investigators have developed a electronic health record-based tool that will recognize children with sepsis early and trigger an alert to their hospital caregivers. The caregivers will be prompted to launch a focused management bundle that can stabilize these children, prevent further deterioration and reduce their chances of sepsis related complications and death. The proposed study will test the validity and effectiveness of this electronic tool in reducing sepsis mortality rates.

NCT ID: NCT01722422 Terminated - Septic Shock Clinical Trials

Hyperoxia and Hypertonic Saline in Septic Shock

Hyper2S
Start date: October 2012
Phase: N/A
Study type: Interventional

Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.

NCT ID: NCT01718613 Completed - Septic Shock Clinical Trials

Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients

VANCS II
Start date: November 2012
Phase: Phase 3
Study type: Interventional

Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.