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

NCT02044575 | Completed

• 1 other identifier: SeptiClock
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Clock genes, circadian regulation

Outcome Measures

Primary Outcomes (1)

• Assessment of circadian regulation

  Circadian regulation by expression of clock genes

  These parameters are measured during intensive care unit stay, for a maximum of 3 days

Secondary Outcomes (14)

• Time on mechanical ventilation

  They are followed up until the end of intensive care unit stay - or, for a maximum of 28 days

• Intensive care unit length of stay

  Participants will be followed for the duration of intensive care stay, an expected average of 4 weeks

• Hospital length of stay

  Participants will be followed for the duration of intensive care stay, an expected average of 5 weeks

• Simplified Acute Physiology Score (SOFA II)

  They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.

• Sequential Organ Failure Assessment (SOFA)

  They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.

Other Outcomes (2)

• Nagalase enzyme activity

  This parameter is measured at the beginning of the investigation

• Venous return

  This parameter is measured at the beginning of the investigation

Study Arms (1)

Critically ill patients

Intensive care unit patients with refractory septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients with septic shock

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating female patient,
• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin

Berlin, 13353, Germany

Location

Related Publications (3)

• Bellet MM, Deriu E, Liu JZ, Grimaldi B, Blaschitz C, Zeller M, Edwards RA, Sahar S, Dandekar S, Baldi P, George MD, Raffatellu M, Sassone-Corsi P. Circadian clock regulates the host response to Salmonella. Proc Natl Acad Sci U S A. 2013 Jun 11;110(24):9897-902. doi: 10.1073/pnas.1120636110. Epub 2013 May 28.

  PMID: 23716692 BACKGROUND

• Lim AS, Chang AM, Shulman JM, Raj T, Chibnik LB, Cain SW, Rothamel K, Benoist C, Myers AJ, Czeisler CA, Buchman AS, Bennett DA, Duffy JF, Saper CB, De Jager PL. A common polymorphism near PER1 and the timing of human behavioral rhythms. Ann Neurol. 2012 Sep;72(3):324-34. doi: 10.1002/ana.23636.

  PMID: 23034908 BACKGROUND

• Lachmann G, Ananthasubramaniam B, Wunsch VA, Scherfig LM, von Haefen C, Knaak C, Edel A, Ehlen L, Koller B, Goldmann A, Herzel H, Kramer A, Spies C. Circadian rhythms in septic shock patients. Ann Intensive Care. 2021 Apr 26;11(1):64. doi: 10.1186/s13613-021-00833-5.

  PMID: 33900485 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 24, 2014
• Study Start: April 1, 2014
• Primary Completion: January 21, 2018
• Study Completion: March 31, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

DE (1)