EPH Septic Shock Observational Study (ESSOS)

Date Added
May 16th, 2022
PRO Number
Pro00119078
Researcher
Andrew Goodwin

List of Studies


Keywords
Genetics, Immune System, Inflammation, Non-interventional
Summary

This is a multicenter, prospective cohort study. This is an observational study with no intervention. The study will consist of data collection via patient/surrogate interview and medical record review and collection of blood during the first three days of septic shock treatment . Blood samples will undergo RNA sequencing, which will be used to classify patients into sepsis phenotypes. Written informed consent from the patient or legally authorized representative (LAR) will be obtained.

Data will be collected for up to 90 days after enrollment. For patients discharged from the hospital prior to Day 28, three post-discharge assessment will be made at Day 28, Day 60, and Day 90 to ascertain vital status.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis

Date Added
April 20th, 2022
PRO Number
Pro00113274
Researcher
Andrew Goodwin

List of Studies


Keywords
Pulmonary
Summary

The purpose of this research is to find out if a drug called ganciclovir can prevent cytomegalovirus (CMV) reactivation, in which the virus wakes up from an inactive state, in patients with respiratory failure associated with severe sepsis. In order for you to take part in this study, we verified that you also have previously had an infection with a virus called Cytomegalovirus (CMV). Ganciclovir is an FDA approved drug that has been widely used for the prevention and treatment of CMV in patients with weakened immune systems. A total of 482 patients will be enrolled in this study at sites throughout the US.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

CONNECTS Master for Clinical Trials targeting macro-, micro-immunothombosis, vascular hyperinflammation, and hypercoagulability and rein-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)

Date Added
March 24th, 2022
PRO Number
Pro00114224
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response with agents targeting the RAAS improves clinical outcomes among patients with COVID-19.
Potential agents to investigate on this platform include TXA127 and TRV027. Both have potential beneficial effects on the RAAS system in COVID-19. We postulate that SARS-CoV-2 spike protein interaction with the ACE2 receptor leads to unchecked activity of AngII, and RAAS-targeting therapies will counterbalance pathologic RAAS effects. We will evaluate the efficacy of TXA127 and TRV027 in restoring RAAS balance.

Institution
MUSC
Recruitment Contact
Nadine O'Connor
843-792-1221
oconnorn@musc.edu

ASTER: A PETAL Network Multi-Center Phase 2b Randomized Double-Blinded Placebo-Controlled Trial of Two Different Pharmacologic Therapies (Intravenous Vitamin C or Intravenous Acetaminophen)

Date Added
October 26th, 2021
PRO Number
Pro00115458
Researcher
Andrew Goodwin

List of Studies


Keywords
Hypertension/ High Blood Pressure, Kidney, Pulmonary
Summary

The purpose of this study is to evaluate if Vitamin C and/or Acetaminophen help with the treatment of sepsis. Participants will be given either Acetaminophen, Vitamin C, or a placebo through an IV for up to 5 days while in the ICU. The study aims to find a new approach for improving blood pressure and/ or the function of the lungs and kidneys for patients with sepsis. A maximum of 900 patients will be enrolled in the study.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
(843) 792-1221
lemattyc@musc.edu

COVID-19: A Mulicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19

Date Added
April 8th, 2021
PRO Number
Pro00109695
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Drug Studies, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

Crystalloids Liberal Or Vasopressors Early Resuscitation In Sepsis

Date Added
August 21st, 2018
PRO Number
Pro00078104
Researcher
Andrew Goodwin

List of Studies


Keywords
Lung, Pulmonary
Summary

This is a research study of different ways to use intravenous fluids (fluids given through a small tube placed in the vein) and vasopressors (medicines used to raise blood pressure) to treat sepsis, which is a serious infection. We are asking you to be in this study because: a) you have been diagnosed with low blood pressure due to an infection and b) your blood pressure has stayed low after your doctors gave you fluids. We do not know which approach is better in this situation: a)starting medicines to raise blood pressure first and then giving more fluids (if needed), or b) giving a larger amount of fluids first and then giving medicines to raise blood pressure if needed. Right now, the choice of approach is left to the doctors. Some doctors use medicines to raise blood pressure followed by extra fluids, and others use extra fluids followed by medicines to raise blood pressure. Some doctors use a combination of the two. This treatment part of the study will last for 24 hours, and then we will follow you until you go back to where you live. We want to find out whether one of these approaches compared to the other can improve a patient's chances of survival.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@musc.edu



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