Sepsis clinical trials at UCSF
7 in progress, 4 open to eligible people
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 5391959, California 5332921 and other locations
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis
open to eligible people ages 2 months to 17 years
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 5391959, California 5332921 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 5378538, California 5332921 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 5391959, California 5332921
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 5391959, California 5332921 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 5391959, California 5332921 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 5391959, California 5332921 and other locations
Our lead scientists for Sepsis research studies include Matt Zinter, MD Judith Hellman, M.D. Matthieu Legrand.
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