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Sepsis clinical trials

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NCT ID: NCT00428051 Terminated - Sepsis Clinical Trials

Colombia Epidemiologic Surveillance Study

LEAP II
Start date: September 2006
Phase: N/A
Study type: Observational

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

NCT ID: NCT00407147 Terminated - Sepsis Clinical Trials

Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection

Start date: July 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA) approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections.

NCT ID: NCT00395161 Terminated - Sepsis Clinical Trials

The CRISIS Prevention Study

CRISIS
Start date: April 2007
Phase: Phase 3
Study type: Interventional

Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.

NCT ID: NCT00318331 Terminated - Sepsis Clinical Trials

Enteral Glutamine in Critical Illness

Start date: May 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Glutamine is an amino acid which is rapidly depleted in critical illness. It is used as energy by cells that line the gut, vital for immune system function, and works as an anti-oxidant. Glutamine supplementation has been shown to improve outcomes in ICU patients. We hypothesize that critically ill patients given extra glutamine will have less of an inflammatory response and therefore better outcomes than patients not given extra glutamine. Our study randomizes patients to tube feeding with OR without extra glutamine to see if it affects patient outcomes as well as markers of inflammation.

NCT ID: NCT00303082 Terminated - Sepsis Clinical Trials

Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.

NCT ID: NCT00299949 Terminated - Sepsis Clinical Trials

Thrombin Generation and Thromboelastography in Non-overt DIC

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

Sepsis is the 13th most common cause of death in the United States, causing approximately 210,000 deaths per year. Once DIC has developed, irreversible organ injury has already occurred and the mortality rate is 70%. Inhibition of systemic coagulation with activated protein C concentrate has been the only therapy for sepsis introduced in the past several decades which has improved outcomes. Elucidation of the coagulopathic mechanisms early in the development of DIC may give rise to targeted therapies and strategies for early intervention. We hypothesize that an increase in endogenous thrombin potential precedes the development of overt DIC by a clinically significant time period. Our primary objective is to determine if endogenous thrombin potential (ETP) measured at first diagnosis of sepsis prior to the onset of DIC and organ failure is predictive of overt DIC and/or poor outcome. We will compare ETP to standard coagulation assays and the clinical assessment of DIC using the ISTH criteria for overt DIC. A secondary objective of this study is to determine if host coagulation variables predispose to the development of DIC and poor clinical outcome during sepsis.

NCT ID: NCT00167596 Terminated - Critical Illness Clinical Trials

Near Infrared Spectroscopy (NIRS) in Severe Sepsis

OTO-STS
Start date: July 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.

NCT ID: NCT00159510 Terminated - Sepsis Clinical Trials

Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome

MB-NO
Start date: April 2004
Phase: Phase 1
Study type: Interventional

Nitric oxide (NO) plays a pivotal role in maintenance of normal vascular tone. However, in sepsis the excessive production of NO results in myocardial depression, vasoplegia, and cytotoxic effects, thus promoting shock and multiple organ dysfunction. A recently completed study from our group showed advantageous cardiovascular effects of continuously infused methylene blue (MB), an inhibitor of NO pathway, in human septic shock. In another investigation, we have found that the combination of inhaled NO and continuously infused MB attenuates endotoxin-induced acute lung injury (ALI) in sheep. Our intention is, in a new study, to test the hypothesis that the combination of MB and NO (MB+NO) improves both cardiovascular and pulmonary functions as well as clinical outcome in patients with septic shock and ALI. Forty mechanically ventilated patients diagnosed with hyperdynamic septic shock and ALI, will be randomized to groups receiving 1. Conventional treatment (control group)(n =10); 2. MB infusion in addition to conventional treatment (n=10); 3. Inhaled NO in addition to conventional treatment (n=10); 4. MB infusion combined with inhaled NO (MB+NO) in addition to conventional treatment (n=10).

NCT ID: NCT00037687 Terminated - Sepsis Clinical Trials

Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

Start date: April 2001
Phase: Phase 3
Study type: Interventional

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

NCT ID: NCT00016523 Terminated - Sepsis Clinical Trials

Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

Preemie iNO
Start date: January 2001
Phase: Phase 3
Study type: Interventional

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.