NCT02044575

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Claudia Spies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Septic Shock

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-01-21
• Completion: 2019-03-31
• First posted: 2014-01-24
• Last updated: 2020-06-16

Locations

1 site across 1 country: Germany