Seraph-100 + State of the Art Care for Septic Shock

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Methodist Hospital, San Antonio, TX
Septic Shock+1 More
Seraph-100 + State of the Art Care - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Blood Purification for the Treatment of Pathogen Associated Shock

See full description

Eligible Conditions

  • Septic Shock

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Seraph-100 + State of the Art Care will improve 2 primary outcomes and 6 secondary outcomes in patients with Septic Shock. Measurement will happen over the course of Discharge from hospital.

28 days
Mortality
Discharge from hospital
Safety - Adverse Events
First 28 days
Efficacy - ICU-free days in the first 28 days
Kidney replacement therapy-free days in the first 28 days
Vasopressor-free days in the first 28 days
Ventilator-free days in the first 28 days
Day 90
Hospital Stay
Survival

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

2 - State of the Art Care
1 of 2
1- Seraph-100 plus State of the Art Care
1 of 2
Active Control
Experimental Treatment

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Seraph-100 + State Of The Art Care is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

1- Seraph-100 plus State of the Art Care
Device
The Seraph 100 Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. Seraph 100 is an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream. It is intended for use with standard, commercially available bloodlines compatible with the pump system used. Female Luer connectors are required to connect to the Seraph 100 blood ports.
2 - State of the Art Care
Device
"State of the Art care"is defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock, available at https://www.sccm.org/SurvivingSepsisCampaign/Home

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 90 days for reporting.

Closest Location

Methodist Hospital - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation
Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
Male or non-pregnant female adult.
At least 18 years of age at time of enrollment.
Within 72 hours of admission to the ICU.

Patient Q&A Section

What is shock?

"When the circulatory system does not produce adequate delivery of oxygen and nutrients to the tissues, ischemia or reperfusion, or both, may occur. Shock is the condition of insufficient blood flow to tissues, resulting in cell damage, organ dysfunction, and eventually death." - Anonymous Online Contributor

Unverified Answer

Can shock be cured?

"In conclusion, shock can not only be eliminated, but may be effectively reduced. Since there are multiple ways shock can be reduced, such as medication and lifestyle changes, shock can be controlled to be a manageable amount." - Anonymous Online Contributor

Unverified Answer

What causes shock?

"shock typically arises from a traumatic injury or acute medical illness, and can be caused by the absence of blood circulation or from the failure of the heart to pump blood with pressure to its delivery site. Symptoms include palpitations, shortness of breath, chest discomfort, loss of consciousness, seizures, and shock-induced hypovolemic anemia. Cardiac tamponade results in shock from a buildup of gas around the heart. Bleeding can cause shock due to loss of volume of blood, so loss of blood may also result from a large traumatic injury." - Anonymous Online Contributor

Unverified Answer

What are common treatments for shock?

"Shock in children can be treated with fluids, medications, and physical stimulation. If other interventions have failed, a child should be transported to a children’s hospital in a level 1 or 2 trauma center. Transfers and trauma may be necessary. The resuscitation team should make clear to parents that there is no cure but this step can prevent complications from the shock itself." - Anonymous Online Contributor

Unverified Answer

How many people get shock a year in the United States?

"around 867,000 people in the U.S. seek medical treatment for severe shock between 1994 and 2001, representing about 7% of visits. Despite increasing rates of shock over that time period, the number of people receiving shock treatment is declining. There was also an increase in the utilization of shock care for people aged 65 or older. As the availability of shock treatment becomes more widespread, and utilization remains high, further research should explore whether shock is used appropriately and by whom." - Anonymous Online Contributor

Unverified Answer

What are the signs of shock?

"Symptoms depend on the cause of shock but include vomiting, low blood pressure (below 70 mm Hg), slow heartbeat, dilated pupils, cold and clammy skin, and blue lips/pulse.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving seraph-100 + state of the art care?

"Seraph-100 + state of the art care appears to be beneficial for patients with shock and septic shock. More research is needed to further understand the mechanisms behind this effect in order to replicate these results in a large, multi-centre trial." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating shock?

"In most treatments, the therapeutic options are based on the clinical use of inorganic salts or oxygen, which do not alter the mechanisms of pathogenesis, and inorganic compounds that increase or decrease the hemodynamic properties of the organism and that act on cellular functions. In recent years, a new pharmacological approach has been developed which is inspired by the discovery that the organism is equipped with an elaborate cellular system of autoregulation which operates on the level of the circulation. It is well known that this autoregulation can be manipulated by injecting several substances and to make some of them block others." - Anonymous Online Contributor

Unverified Answer

Does seraph-100 + state of the art care improve quality of life for those with shock?

"Improvements in the quality of life of those with severe septic shock were observed with implementation of new treatment guidelines and the administration of Seraph-100." - Anonymous Online Contributor

Unverified Answer

How does seraph-100 + state of the art care work?

"Seraph-100 + state of the art care leads to a major reduction in cardiac arrests. Although the risk of cardiac arrest is increased during the start of Seraph-100 therapy, the risk seems to decrease when patients are stabilized and are then treated with Seraph-100 in a clinical trial. Recent findings must be taken into account in discussions about the value of Seraph-100 in pediatric patients." - Anonymous Online Contributor

Unverified Answer

How serious can shock be?

"Shock as defined by admission to ICU was associated with significant morbidity and mortality. Patients admitted to ICU with a simplified Acuity Score>15 have an in-hospital mortality of 44%. Patients with a simplified Acuity Score>15 are at high risk for early post-ICU neurological injury and are likely to require prolonged ICU admission." - Anonymous Online Contributor

Unverified Answer

Is seraph-100 + state of the art care typically used in combination with any other treatments?

"Many patients still needed to be treated with the use of state of the art care combined with any other treatments. In a recent study, findings did not identify any single treatment that would optimally control both pain and swelling; thus, an effective treatment would require both pain and swelling to be optimally controlled in conjunction with other treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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