Treatment for Pyemia

Phase-Based Estimates
1
Effectiveness
1
Safety
UPMC Presbyterian, Pittsburgh, PA
Pyemia+4 More
Eligibility
18+
All Sexes
Eligible conditions
Pyemia

Study Summary

This study is evaluating whether a new care model can help reduce the number of days spent in the hospital for individuals with sepsis or lower respiratory tract infection.

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Eligible Conditions

  • Pyemia
  • Sepsis
  • Pneumonia
  • Toxemia
  • Covid19
  • Lower Resp Tract Infection

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Pyemia. Measurement will happen over the course of measured at 90 days after discharge to home.

Day 90
Post-discharge home days
baseline, 90 days
Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)
Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)
measured at 90 days
Hospital readmissions
Mortality
Day 90
Emergent outpatient utilization
Transition to Hospice

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)

This trial requires 1668 total participants across 5 different treatment groups

This trial involves 5 different treatments. Treatment 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.

High-intensity Remote Patient Monitoring (RPM) plus the Standard Team (RPM-High, Standard Team)Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' primary care provider (PCP) or specialist to coordinate care and ensure timely follow-up.
Low-intensity Remote Patient Monitoring (RPM) + Enhanced Team (RPM-Low, Enhanced Team)Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans. In addition to reacting to RPM triggers, team members (e.g., CRNP, social workers, nurses) meet with the patient in-person or virtually in the week after discharge and at least twice more in the next 90 days, conduct assessments and a pharmacy review, develop care plans, and discuss advance directives).
High-intensity Remote Patient Monitoring (RPM) plus the Enhanced Team (RPM-High, Enhanced Team)Questions are pushed to patients multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans.Team members (e.g., CRNP, social workers, nurses) address RPM triggers, meet with the patient three times, pharmacy review, develop care plans, and discuss advance directives).
Structured Telephone Support (STS)
Behavioral
Post-discharge assessment, education, and medication reconciliation delivered telephonically by a health plan case manager, home care as needed, and follow-up with the primary care provider (PCP) within seven days post-discharge.
Low-intensity Remote Patient Monitoring (RPM) + Standard Response Team (RPM-Low, Standard Team)Questions are pushed to members patients times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team. RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' primary care provider (PCP) or specialist to coordinate care and ensure timely follow-up.

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
K. C.
Kalpana Char, Associate Vice President
University of Pittsburgh

Closest Location

UPMC Presbyterian - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Discharged to home, independent living facility, or skilled nursing facility
UPMC Health Plan members
Age 21+ -Hospitalized with a primary diagnosis of sepsis or lower respiratory tract infection, --
Readmission risk is moderate or high

Patient Q&A Section

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

Can pyemia be cured?

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In patients with pyemia, the risk of death is reduced by long-term antibiotic therapy, but not by the use of prophylactic antibiotics in persons not at risk.

Unverified Answer

What are common treatments for pyemia?

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Therapeutic strategies for pyemia treatment are complex, but all involve antibiotic therapy. Because these strategies vary by age group, physicians typically tailor treatment recommendations based on the age of the patient. In elderly women with urinary tract infections who are asymptomatic, antibiotics to prevent further complicated UTIs or bladder lesions are often prescribed.

Unverified Answer

What is pyemia?

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Pyemia is a common and costly condition that often has a delayed and vague onset. In the prehospital environment, the diagnosis of pyemia is often missed, even when laboratory blood tests are performed. The majority of the time, physicians do not have the opportunity to suspect a pyemia. In the emergency department, the treatment of pyemia should be the main focus and prompt treatment is highly recommended.

Unverified Answer

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

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It is estimated that in 2012 15 million US adults will be diagnosed with pyemia. This accounts for 26% of new cases in adults. Furthermore, about 7.9 million will die of this complication.

Unverified Answer

What are the signs of pyemia?

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In summary, physical examination can assist in differentiating between pyemia and other causes of fevers. In particular, physical signs such as a cool, sluggish skin, rapid temperature rise, and a raised respiration rate are significant and can raise suspicion for pyemia. If the patient is haemodynamically unwell, it can be necessary to rule out a number of illnesses and conditions. Laboratory blood counts must be performed for timely diagnosis and for monitoring treatments. In patients who are haemodynamically unstable, the combination of low platelet count and elevated white cell count may be a useful criterion for suspicion and treatment of pyemia.

Unverified Answer

What causes pyemia?

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The source of pyemias is usually the urinary tract. Other potential causes, such as urinary tract infection, kidney disease or other chronic conditions, may need to be ruled out. Other causes of pyemias may include thromboses of veins, arteries or the spinal canal. Other causes include a wide range of other systemic and local conditions.\n

Unverified Answer

Have there been other clinical trials involving treatment?

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In the US, current clinical trials that include patients with a diagnosis of SLE are required by law to report adverse events which occur in greater than 12.5% of patients. The frequency of side effects reported in the clinical trial reporting database appear to match the frequency noted in the reports from previous clinical trials.

Unverified Answer

Is treatment safe for people?

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Patients treated safely with antibiotics are likely to benefit and should continue receiving treatment. The routine use of antibiotics for acute pyelonephritis in children is not supported by either clinical evidence or the evidence reviewed herein. However, the routine use of antibiotics for uncomplicated urinary tract infection and in certain respiratory infections is well established.

Unverified Answer

What are the common side effects of treatment?

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The common adverse effects are transient post-hemorrhagic thrombocytopenia. Most of them are related to hemorrhage, and are dose independent. The thrombocytopenia lasts after treatment has stopped. The most common manifestations of hemolysis are anasarca and fatigue.

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Has treatment proven to be more effective than a placebo?

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With conventional treatment and antibiotic therapy, the 5-year survival for patients with sepsis was 53% as compared to 33% in patients with pyemia without sepsis. These figures highlight the importance of early diagnosis and treatment of sepsis (pyemia) in order to improve outcomes.

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How does treatment work?

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A small cohort of patients developed persistent pyonephrosis after treatment for non-obstructive aequolaparengia. No definite cause for the onset of pyonephrosis after pyelolithotomy has been established, but the fact that pyonephrosis always returns after pyelolithotomy and can be effectively treated with antibiotic treatment has led to speculation of either ongoing infection or malfunctioning of pyelolithotomy itself. A larger prospective study, with a longer follow-up is needed to elucidate the true significance of persistent pyonephrosis after pyelolithotomy.

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Is treatment typically used in combination with any other treatments?

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Treatment regimens are commonly used in combination with other modalities to improve responses to antimicrobial treatment, particularly for MRSA and VRE. However, not all the studies provided data that could answer the question of the most appropriate regimen for treating people with VRE.

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