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Sepsis clinical trials at UCSF

7 in progress, 3 open to eligible people

Sepsis is a life-threatening reaction to infection that affects the whole body. UCSF is studying a treatment for kidney injury caused by sepsis through a trial investigating TIN816. Another trial investigates how natural genetic elements impact immune aging in sepsis. UCSF is also exploring hydrocortisone use in children with septic shock.

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  • TIN816 in Sepsis-associated Acute Kidney Injury (CLEAR-AKI)

    open to eligible people ages 18-85

    The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

    San Francisco, California and other locations

  • Stress Hydrocortisone In Pediatric Septic Shock

    open to eligible people ages 1 month to 17 years

    SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock. It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).

    Oakland, California and other locations

  • Role of Transposable Elements in Septic Immune Aging

    open to eligible people ages 18 years and up

    The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is: 1. Do transposable elements prematurely age the immune systems of patients with sepsis? 2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU? 3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU? Participants will have blood drawn from them but will not be subjected to additional interventions.

    San Francisco, California

  • GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study

    Sorry, in progress, not accepting new patients

    This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS. Those children who demonstrate immunoparalysis (TNF-alpha response <200 pg/ml) will receive a 7-day course of GM-CSF at a dose of 125 or 250 mcg/m2/day by either the intravenous (IV) or subcutaneous (SQ) route. The goal of the study is to establish the dose and route of delivery that results in resolution of immunoparalysis (TNF-alpha response >=200 pg/ml) by the morning after the 3rd scheduled dose with persistent resolution of immunoparalysis on the morning after the 7th scheduled dose. Resolution of immunoparalysis in 8 out of the first 10 subjects in a study treatment arm represents a successful dose and route. The goal of this study will be achieved through the following Specific Aims: Specific Aim 1. Establish the immunologic efficacy of GM-CSF administered by the IV and SQ routes in children with immunoparalysis in the setting of sepsis-induced MODS. Specific Aim 2. Estimate the pharmacokinetic parameters by the IV and SQ GM-CSF administered in pediatric sepsis-induced MODS. Specific Aim 3. Demonstrate the feasibility of screening, enrollment, drug delivery, and sample collection for a multi-center immunostimulation trial in children with sepsis-induced MODS.

    San Francisco, California and other locations

  • Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

    Sorry, in progress, not accepting new patients

    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.

    San Francisco, California and other locations

  • Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study

    Sorry, in progress, not accepting new patients

    Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock

    San Francisco, California and other locations

  • APS Phenotyping Study

    Sorry, not currently recruiting here

    The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. This study will also generate a biobank of specimens collected from these patients that will be available to investigators for future studies of ARDS, sepsis, and/or pneumonia.

    San Francisco, California and other locations

Our lead scientists for Sepsis research studies include .

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