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Clock Genes in Patients With Refractory Septic Shock (SeptiClock) - Pilot Study

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ClinicalTrials.gov Identifier: NCT02044575
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Brief Summary:

Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based sepsis therapy bundles) the mortality of septic shock remains high and causes high socioeconomical burden of disease.

The purpose of this pilot study is to evaluate the design and conduct of a projected full scale clinical trial.


Condition or disease
Septic Shock

Detailed Description:

A functional clock is required for induction of several proinflammatory genes, not shown in septic patient settings, yet.

Clock genes are involved in modulating the activity of several transcription factors that are important regulators of immune functions (e.g. HIF1-α, STAT1, STAT3, and NF-κB) (Bellet MM et al., 2013).

Furthermore, polymorphisms such as rs7221412, a common polymorphism near period homolog 1 (PER1), was associated with the timing of activity rhythms and also showed a suggestive time-dependent relationship with both cerebral cortex and monocytes PER1 expression and an association with time of death (Lim ASP et al., 2012).

This explorative project is a pilot study. First data are generated for the assessment of the circadian system in patients with septic shock.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clock Genes in Patients With Refractory Septic Shock (SeptiClock) - Pilot Study
Actual Study Start Date : April 2014
Actual Primary Completion Date : January 21, 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Critically ill patients
Intensive care unit patients with refractory septic shock



Primary Outcome Measures :
  1. Assessment of circadian regulation [ Time Frame: These parameters are measured during intensive care unit stay, for a maximum of 3 days ]
    Circadian regulation by expression of clock genes


Secondary Outcome Measures :
  1. Time on mechanical ventilation [ Time Frame: They are followed up until the end of intensive care unit stay - or, for a maximum of 28 days ]
  2. Intensive care unit length of stay [ Time Frame: Participants will be followed for the duration of intensive care stay, an expected average of 4 weeks ]
  3. Hospital length of stay [ Time Frame: Participants will be followed for the duration of intensive care stay, an expected average of 5 weeks ]
  4. Simplified Acute Physiology Score (SOFA II) [ Time Frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days. ]
  5. Sequential Organ Failure Assessment (SOFA) [ Time Frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days. ]
  6. Therapeutic Intervention Scoring System (TISS-28) [ Time Frame: They are measured until the end of intensive care unit stay - or, for a maximum of 28 days. ]
  7. Mortality [ Time Frame: 6 months after intensive care unit discharge ]
  8. Light frequencies [ Time Frame: Light frequencies are measured until the end of intensive care unit stay - or, for a maximum of 28 days ]
  9. Light levels (lux) [ Time Frame: Light levels are measured until the end of intensive care unit stay - or, for a maximum of 28 days ]
  10. Cortisol [ Time Frame: This parameter is measured in ng/ml during intensive care unit stay, for a maximum of 3 days ]
  11. Melatonin [ Time Frame: This parameter is measured in pg/ml during intensive care unit stay, for a maximum of 3 days ]
  12. Quality of life [ Time Frame: Up to 3 and 6 months ]
    Quality of life is measured by SF-36 questionnaire

  13. Cognitive function [ Time Frame: Up to 3 and 6 months ]
    Cognitive function is measured by Repeatable Battery for the Assessment of Neuropsychological Status

  14. Multiplex-Genexpression analysis [ Time Frame: These parameters are measured during intensive care unit stay, for a maximum of 3 days ]
    Ncounter neuroinflammation and micro rna panel are analysed


Other Outcome Measures:
  1. Nagalase enzyme activity [ Time Frame: This parameter is measured at the beginning of the investigation ]
    Nagalase Enzyme activity is expressed in nmol/min per Milliliter. Analysis is evaluated with the perioperative Nagalase results of 10 patients in the clinical trial Phydelio (EudraCT-No 2008-007237-47).

  2. Venous return [ Time Frame: This parameter is measured at the beginning of the investigation ]
    Venous return will be assessed after ICU admission by venous return pressure gradient (dVR)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients with septic shock
Criteria

Inclusion Criteria:

  • Male and female patients with age 18 years and above,
  • Patient at intensive care units (8i, 9i and 1i at Charité - University Medicine Berlin , Campus Virchow- Klinikum),
  • Septic shock (ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) consensus definitions) AND Norepinephrine dosage of >0.3 μg/kg/min for at least 2 hours

Exclusion Criteria:

  • Pregnant or lactating female patient,
  • Participation in another interventional study (30 days before study inclusion and during study participation),
  • Acute leucemia,
  • Severe leukocytosis (>50,000/nl),
  • Severe thrombocytopenia (<5,000/nl),
  • Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent or previous transplantation,
  • Patients receiving interferon therapy (last 14 days),
  • Patients with known hypersensitivity GM-CSF or known antibodies against GM-CSF, yeast-derived products or any component of the study medication,
  • Ongoing (concomitant) chemotherapy or radiotherapy for malignancy,
  • Acute pulmonary embolism or acute myocardial infarction within last 72 hours,
  • Cardiopulmonary resuscitation within last 7 days,
  • Moribund patient (life expectancy <72 hrs.),
  • Presence of a do-not-resuscitate or do-not-intubate order,
  • Known human immunodeficiency virus (HIV) infection or chronic viral hepatitis
  • Lacking willingness to save and hand out data within the study
  • Accommodation in an institution due to an official or judicial order
  • The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
  • Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044575


Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Claudia Spies
Investigators
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Study Director: Claudia Spies, MD, Prof. Charite University, Berlin, Germany
Publications:
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Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02044575    
Other Study ID Numbers: SeptiClock
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
Clock genes, circadian regulation
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation