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Septic clinical trials

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NCT ID: NCT04404387 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Lessening Organ Dysfunction With VITamin C in Septic ARDS

LOVIT ARDS
Start date: July 22, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients. As secondary objectives, the study aims: - To compare the effect of high-dose intravenous vitamin C vs. placebo on: 1. 6-month mortality; 2. 6-month HRQoL; 3. organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU); 4. global tissue dysoxia (at baseline); 5. oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated); 6. occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20; 7. acute hemolysis as defined by: - clinician judgment of hemolysis, as recorded in the chart, or - hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: - reticulocyte count >2 times upper limit of normal at clinical site lab; - haptoglobin < lower limit of normal at clinical site lab; - indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; - lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells; 8. hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L. - To assess baseline vitamin C levels in study participants (before the first dose of investigational product).

NCT ID: NCT04102371 Recruiting - Shock Clinical Trials

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

PRoMPT BOLUS
Start date: August 25, 2020
Phase: Phase 3
Study type: Interventional

The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.

NCT ID: NCT02069028 Active, not recruiting - Sepsis Clinical Trials

Effectiveness of Different Interventions for Implementing Surviving Sepsis Campaign (SSC) Guidelines on Compliance and Mortality: Systematic Review and Meta-analysis

Start date: February 2014
Phase: N/A
Study type: Observational

This is a systematic review and Meta-Analysis of interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction

NCT ID: NCT00457613 Completed - Shock Clinical Trials

Effects of Alkaline Phosphatase on Renal Function in Septic Patients

Start date: November 2004
Phase: Phase 2
Study type: Interventional

Septic shock is the most common cause of death in patients requiring intensive care. The kidney is one of the first organs to fail, stressing the importance to search for clinical interventions that may protect the kidneys during sepsis. Alkaline phosphatase functions as a host defence molecule and is present in many cells and organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for mammals which acts as a partial antagonist on the LPS receptor complex. In several animal studies, administration of alkaline phosphatase attenuates the inflammatory response and reduces mortality. It is unknown whether these results can be extrapolated to septic patients . We studied the effects of alkaline phosphatse administration on kidney damage and function in patients with severe sepsis or septic shock.

NCT ID: NCT00313365 Withdrawn - Arthritis Clinical Trials

Surgical Lavage vs Serial Needle Aspiration for Infected Joints

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

Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury to the joint space could cause the entry of microorganisms, with the potential to cause infection. Septic arthritis refers to the infection of a joint space with microorganisms, usually bacteria. This invasion initiates a process of inflammation and causes irreversible damage to a joint cavity. Patients typically present with pain, swelling, decreased motion, and inability to use the joint. When bacteria enter a joint space, the host immune system responds by concentrating inflammatory cells within the joint. While inflammatory cells serve to eliminate the bacteria, they also produce substances that not only attack bacteria but also could destroy the joint space. These substances are called enzymes, and they could damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone in the process. Because cartilage has a poor ability to cure itself, this process may lead to irreversible damage and chronic joint dysfunction. Studies have found that signs of early joint damage can be found within hours following joint infection. This is true even if antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection. Also, delay in treatment has been related to poor outcome. However, the best method of treating septic arthritis has yet to be determined. Currently, there are two accepted ways for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space in the OR under anesthesia). Antibiotics are also used with these two forms of treatment. Supporters of surgery believe that the most dependable method of eliminating bacteria from a joint space is through arthrotomy (opening the joint with a surgical incision) and lavage (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration support this method because it is quick, does not require opening the joint space, and can be performed without anesthesia.At present, there are no conclusive studies comparing the two techniques. Hopefully, this study will help delineate the best course of management.