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Shock, Septic clinical trials

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NCT ID: NCT01312688 Not yet recruiting - Sepsis Clinical Trials

Early Goal-directed Therapy and Myocardial Dysfunction

SEPT-MD
Start date: July 2011
Phase: N/A
Study type: Interventional

The cardiovascular system plays a central role in the pathophysiology and prognosis of sepsis, yet the correct hemodynamic management of septic patients is still vigorously debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate prediction of fluid requirement. Recently studies showed that early goal-directed therapy (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock patients, yet EGDT has not been adopted by all intensivists. The investigators have recently found using 2D echocardiography in 262 patients with severe sepsis or septic shock and treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and reduced stroke volume index are strong independent predictors of mortality. In the present study the investigators intend to test the effect of EGDT on resuscitation, on long term myocardial function and left ventricular volumes and on survival in ICU patients with severe sepsis and septic shock. Patients will be randomized to EGDT (resuscitation directed by ScvO2) or standard of therapy for the first six hours after diagnosis of severe sepsis or septic shock and admission to the ICU. After six hours patients in septic shock will be further monitored with non invasive cardiac output (PiCCO, Pulsion Technologies). All patients will be followed daily by 2D & 3D transthoracic echocardiography with detailed measurements of systolic and diastolic left and right ventricular volumes and functions. Patients in the EGDT group will be compared to the control group for parameters of initial resuscitation (fluid volumes, ScvO2 achieved, inotrope use), initial values from non invasive cardiac output at six hours, interventions required from institution of non invasive cardiac output, early and long term effects on cardiac function and volumes from echo measurements, and mortality. The effectiveness of EGDT will thus be examined in the short and long terms.

NCT ID: NCT01310790 Completed - Shock, Septic Clinical Trials

Strategy of Early Improvement of Tissue Oxygenation Decrease the Mortality of Severe Sepsis and Septic Shock

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The impact of lactate guided therapy on septic shock has not been extensively investigated, however the goal directed therapy has been used for years. The investigators aim was to test the hypothesis that lactate directed hemodynamic therapy is associated with improving the outcome of patients with septic shock by comparing different goal directed strategies which have been commonly recommended clinically. In this multicenter, randomized trial, the investigators assigned patients with septic shock to three groups: Patients were treated with hemodynamic therapy directed either by conventional parameters treatment (control group), or central venous oxygen saturation (ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of death at 28 days after randomization and in-hospital mortality; secondary end points include hemodynamic states, time to goal-achievement.

NCT ID: NCT01304680 Recruiting - Cancer Clinical Trials

Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock

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

Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.

NCT ID: NCT01296789 Terminated - Septic Shock Clinical Trials

Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients

Start date: February 2011
Phase: N/A
Study type: Interventional

The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.

NCT ID: NCT01284452 Completed - Septic Shock Clinical Trials

Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Start date: December 2010
Phase: N/A
Study type: Interventional

Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.

NCT ID: NCT01280942 Completed - Septic Shock Clinical Trials

Early Warning System for Clinical Deterioration on General Hospital Wards

Start date: January 2011
Phase: N/A
Study type: Interventional

The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.

NCT ID: NCT01271153 Completed - Septic Shock Clinical Trials

Effects of Dobutamine on Microcirculation, Regional and Peripheral Perfusion in Septic Shock Patients

Start date: August 2010
Phase: N/A
Study type: Interventional

The investigators hypothesize that dobutamine is able to revert negative redistribution of flow by inducing a selective vasodilatory effect on hypoperfused territories, particularly at the sublingual and gastric mucosa, and at the peripheral tissues. The investigators designed a randomized, cross-over, placebo-controlled study looking at the acute physiologic effects of 5 mcg/kg/min fixed-dose of dobutamine on cardiac function, microcirculation, gastric mucosal, hepatosplanchnic, and peripheral perfusion in septic shock patients.

NCT ID: NCT01271114 Terminated - Septic Shock Clinical Trials

Hypertonic Saline and Terlipressin for Sepsis-associated Hypotension

HYSATESS-p
Start date: June 2012
Phase: Phase 3
Study type: Interventional

In hypotensive septic patients with controlled source, an hemodynamic management protocol including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction) Score by at least 3 points compared to the use of physiologic saline and norepinephrine. The appropriate design for this trial would be factorial. For the time being, will consider de intervention as a whole unit for this pilot study. In the future an appropriately sized factorial multicentric study shall be necessary. Other goals of the pilot study: 1. HS restores preload parameters adequately 2. HS associated with terlipressin normalizes blood pressure in septic shock 3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L 4. There is an inverse relationship between plasma sodium and procalcitonin levels 5. HS increases plasma levels of vasopressin (AVP) 6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)

NCT ID: NCT01263977 Completed - Septic Shock Clinical Trials

Thermodilution - Controlled Management of Volume Therapy in Septic Shock

THEMIS
Start date: December 2010
Phase: N/A
Study type: Interventional

Septic shock and multi-organ failure are among the most frequent causes of death in the ICU. Patients with septic shock require early implementation of hemodynamic therapy to keep the duration of shock state and with it microcirculatory disturbances as short as possible. In the septic shock guidelines by the american association SCCM the diagnosis of volume status is based on filling pressures, like CVP. Some studies show, that the CVP depends not only on the intravascular volume, but also on the right ventricular compliance, pulmonary vascular resistance as well as intrathoracic pressure. The aim of the Study is to evaluate if the duration of septic shock can be reduced through algorithm driven volume therapy orientated to thermodilution based volume parameters (GEDI and ELWI)

NCT ID: NCT01234285 Withdrawn - Sepsis Clinical Trials

Safety of Heparin in Patients With Septic Shock

Start date: December 2010
Phase: Phase 2
Study type: Interventional

Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. The investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. This is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.