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D018805: Sepsis

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (14)


Name (Synonyms) Correlation
drug2242 MMR vaccine Wiki 0.35
drug241 Airway pressure release ventilation Wiki 0.35
drug3006 Plasma expansion with Ringer's Acetate Wiki 0.35
Name (Synonyms) Correlation
drug4040 Toraymyxin PMX-20R (PMX Cartridge) Wiki 0.35
drug110 ALLOCETRA-OTS Wiki 0.35
drug2083 LEAF-4L6715 Wiki 0.35
drug3290 Recombinant human alkaline phosphatase Wiki 0.35
drug2555 Nitazoxanide Tablets Wiki 0.35
drug88 ACE inhibitor, angiotensin receptor blocker Wiki 0.35
drug53 2D Telemedicine Wiki 0.25
drug62 3D Telemedicine Wiki 0.20
drug4482 exhaled breath sampling Wiki 0.20
drug2916 Placebo Wiki 0.06
drug421 Azithromycin Wiki 0.06

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D014115 Toxemia NIH 0.63
D000071074 Neonatal Sepsis NIH 0.35
D019446 Endotoxemia NIH 0.35
Name (Synonyms) Correlation
D011645 Puerperal Infection NIH 0.35
D066087 Perinatal Death NIH 0.35
D063130 Maternal Death NIH 0.35
D012772 Shock, Septic NIH 0.25
D011251 Pregnancy Complications, Infectious NIH 0.20
D003643 Death, NIH 0.18
D018746 Systemic Inflammatory Response Syndrome NIH 0.18
D012769 Shock, NIH 0.14
D058186 Acute Kidney Injury NIH 0.14
D013577 Syndrome NIH 0.03
D012127 Respiratory Distress Syndrome, Newborn NIH 0.03
D055371 Acute Lung Injury NIH 0.03
D012128 Respiratory Distress Syndrome, Adult NIH 0.03
D011014 Pneumonia NIH 0.02
D007239 Infection NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0100806 Sepsis HPO 1.00
HP:0003811 Neonatal death HPO 0.35
HP:0040187 Neonatal sepsis HPO 0.35
Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.14
HP:0002090 Pneumonia HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 8 clinical trials


1 MR-Evaluation of Renal Function In Septic Patients

A study of renal blood flow and renal oxygenation measured by magnetic resonance after a standardized fluid challenge in critically ill, resuscitated, patients with sepsis due to COVID-19 or other agents.

NCT02765191
Conditions
  1. Sepsis, Severe
  2. Acute Kidney Injury
  3. COVID-19
Interventions
  1. Other: Plasma expansion with Ringer's Acetate
MeSH:Sepsis Acute Kidney Injury
HPO:Acute kidney injury Sepsis

Primary Outcomes

Description: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST), compared to baseline measurement

Measure: Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus

Time: When achieved according to protocol, approximately 3-10 minutes after intervention

Description: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.

Measure: Descriptive renal oxygenation and blood flow in critical illness due to sepsis

Time: During Critical illness - at one time point

Description: Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) images stratified in groups in regards to KDIGO grade during exam.

Measure: Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI.

Time: During Critical illness - at one time point
2 Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

NCT03871491
Conditions
  1. Maternal Death
  2. Maternal Infections Affecting Fetus or Newborn
  3. Neonatal SEPSIS
  4. Maternal Sepsis During Labor
  5. Neonatal Death
  6. Postpartum Sepsis
Interventions
  1. Drug: Azithromycin
  2. Drug: Placebo
MeSH:Infection Sepsis Toxemia Neonatal Sepsis Pregnancy Complications, Infectious Puerperal Infection Perinatal Death Maternal Death Death
HPO:Neonatal death Neonatal sepsis Sepsis

Primary Outcomes

Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

Time: within 6 weeks (42 days)

Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

Time: 4 weeks (28 days) post-delivery

Secondary Outcomes

Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.

Measure: Incidence of chorioamnionitis

Time: prior to delivery

Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.

Measure: Incidence of endometritis

Time: within 42 days post-delivery

Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).

Measure: Incidence of other infections

Time: within 42 days post-delivery

Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.

Measure: Incidence of use of subsequent maternal antibiotic therapy

Time: after randomization to 42 days post-delivery

Description: Time from drug administration until initial discharge after delivery (time may vary by site).

Measure: Maternal initial hospital length of stay

Time: within 42 days post-delivery

Description: Maternal readmissions within 42 days of delivery

Measure: Incidence of maternal readmissions

Time: within 42 days post-delivery

Description: Maternal admission to special care units

Measure: Incidence of maternal admission to special care units

Time: within 42 days post-delivery

Description: Maternal unscheduled visit for care

Measure: Incidence of maternal unscheduled visit for care

Time: within 42 days post-delivery

Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.

Measure: Incidence of maternal GI symptoms

Time: within 42 days post-delivery

Description: Maternal death due to sepsis using the Global Network algorithm for cause of death

Measure: Incidence of maternal death due to sepsis

Time: within 42 days post-delivery

Description: Incidence of other neonatal infections.

Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection)

Time: within 42 days post-delivery

Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).

Measure: Neonatal initial hospital length of stay

Time: within 28 days of delivery

Description: Neonatal readmissions within 42 days of delivery

Measure: Incidence of neonatal readmissions

Time: within 42 days of delivery

Description: Neonatal admission to special care units

Measure: Incidence of neonatal admission to special care units

Time: within 28 days of delivery

Description: Neonatal unscheduled visit for care

Measure: Incidence of neonatal unscheduled visit for care

Time: within 42 days post-delivery

Description: Neonatal death due to sepsis using the Global Network algorithm for causes of death

Measure: Incidence of neonatal death due to sepsis

Time: within 28 days of delivery

Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.

Measure: Incidence of pyloric stenosis within 42 days of delivery

Time: within 42 days of delivery
3 Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

NCT04352985
Conditions
  1. Septic Shock
  2. Endoto
  3. Endotoxemia
  4. COVID
  5. Corona Virus Infection
  6. Sepsis, Severe
Interventions
  1. Device: Toraymyxin PMX-20R (PMX Cartridge)
MeSH:Shock, Septic Endotoxemia Sepsis Coronavirus Infections Severe Acute Respiratory Syndrome Shock
HPO:Sepsis

4 SQuISH-COVID: A Pilot Study

This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.

NCT04372472
Conditions
  1. Sepsis
  2. COVID-19
MeSH:Sepsis
HPO:Sepsis

Primary Outcomes

Description: The SeptiScan System is an investigational microfluidic assay that measures the biophysical properties of human leukocytes as an aid, in conjunction with other clinical assessments, to detect life-threatening organ dysfunction caused by a dysregulated host immune response to infection. The SeptiScan System score is presented in three Interpretation Bands of low, intermediate, and high probability of disease. Remnant blood samples will be obtained from subjects in Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. The blood samples will be analyzed using the SeptiScan System.

Measure: To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection.

Time: Day of enrollment through Day 5
5 A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes

This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) and are receiving artificial respiratory support due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.

NCT04378920
Conditions
  1. COVID19, Sepsis or Other Causes
  2. Acute Respiratory Distress Syndrome
Interventions
  1. Drug: LEAF-4L6715
MeSH:Sepsis Toxemia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome
HPO:Sepsis

Primary Outcomes

Measure: proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio

Time: 24 hours

Secondary Outcomes

Measure: proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg

Time: 24, 48 and 72 hours

Measure: all cause mortality

Time: 28 days
6 A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI

Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. The study has three distinct SA-AKI trial populations: 1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 3. A COVID-19 population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients. There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

NCT04411472
Conditions
  1. Acute Kidney Injury Due to Sepsis
Interventions
  1. Biological: Recombinant human alkaline phosphatase
  2. Other: Placebo
MeSH:Sepsis Acute Kidney Injury
HPO:Acute kidney injury Sepsis

Primary Outcomes

Description: To demonstrate an effect of recAP on 28 day all cause mortality

Measure: 28-day all-cause mortality

Time: 28 days

Secondary Outcomes

Description: MAKE 90: dead or on RRT or ≥25% decline in estimated glomerular filtration rate (eGFR) on Day 90 relative to the known or assumed pre-AKI reference level.

Measure: To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).

Time: 90 Days

Description: Days alive and free of organ support through Day 28, i.e., days alive with no MV, RRT, vasopressors or inotropes (with death within 28 days counting as zero days).

Measure: To investigate the effect of recAP on use of organ support, i.e., mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors or inotropes.

Time: 28 days

Description: Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

Measure: To investigate the effect of recAP on length of stay (LOS) in ICU.

Time: 28 days

Description: Time to death through Day 90.

Measure: To investigate the effect of recAP on 90-day allcause mortality

Time: 90 days
7 Use of a Live Attenuated Vaccine Repurposed as an Innate Immune-based Preventive Against COVID-19-associated Sepsis/Inflammation

The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers, first responders), can induce non-specific trained innate immune leukocytes that can prevent/dampen pathological inflammation and sepsis associated with COVID-19-infection, if exposed.

NCT04475081
Conditions
  1. Sepsis Syndrome
Interventions
  1. Biological: MMR vaccine
MeSH:Sepsis Toxemia Systemic Inflammatory Response Syndrome
HPO:Sepsis

Primary Outcomes

Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

Measure: Induction of myeloid-derived suppressor cells (MDSCs)

Time: 14 days post-vaccination

Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

Measure: Induction of MDSCs

Time: 30 days post vaccination

Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

Measure: Induction of MDSCs

Time: 60 days post vaccination

Description: peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

Measure: Induction of MDSCs

Time: 12 months post vaccination

Secondary Outcomes

Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Measure: COVID-19 infection positive

Time: 14 days post-vaccination

Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Measure: COVID-19 infection positive

Time: 30 days post-vaccination

Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Measure: COVID-19 infection positive

Time: 60 days post-vaccination

Description: COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

Measure: COVID-19 infection positive

Time: 12 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 14 days post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 30 days post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 60 days post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 3 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 4 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 5 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 6 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 7 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 8 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 9 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 10 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 11 months post-vaccination

Description: Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

Measure: Health questionnaire

Time: 12 months post-vaccination
8 A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

A phase II, multi-center (approximately 10 sites in Israel), randomized, placebo-controlled, dose- finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in up to 160 adult sepsis patients with organ sysfunction.

NCT04612413
Conditions
  1. Sepsis
  2. Community-acquired Pneumonia
  3. Organ Dysfunction Syndrome
Interventions
  1. Drug: ALLOCETRA-OTS
  2. Other: Placebo
MeSH:Sepsis Toxemia Pneumonia
HPO:Pneumonia Sepsis

Primary Outcomes

Description: Number and severity of AEs and SAEs throughout 28 days follow up period

Measure: To compare the safety of different doses and regimens of Allocetra-OTS to that of Placebo in the treatment of organ failure in adult sepsis patients

Time: 28 days

Description: Change from baseline in SOFA score throughout 28 days

Measure: To compare the efficacy of different doses and regimens of Allocetra-OTS to that of Placebo in the treatment of organ failure in adult sepsis patients

Time: 28 days

Secondary Outcomes

Description: Vasopressor-free days over 28 days.

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: Ventilator-free days over 28 days

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients.

Time: 28 days

Description: Days without renal replacement therapy (dialysis).

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: Time in ICU and time in hospital

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: Number of days with creatinine ≤ Baseline levels +20%.

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: All-cause mortality at Day 28 following first dose

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: Changes in CRP levels

Measure: compare other clinical manifestations of different doses and regimens of Allocetra-OTS associated with organ failure in sepsis patients

Time: 28 days

Description: Number and severity of AEs and Serious Adverse Events (SAEs) throughout 12 months follow up period

Measure: Assess long term safety follow up

Time: 12 months

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

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Alphabetical index of all Terms

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