Insufficient Oxygenation in Septic Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Critical Care
- Fluid Therapy
- Mitochondria
- Oxygen
- Sepsis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which pos...
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disbalance in the cell and therefore a physiological trigger for fluid therapy. Objectives: 1. To describe mitoPO2 measurements in patients with sepsis who are about to receive fluid therapy 2. To describe the effects of fluid therapy and the associated change in mitoPO2 and change in other physiologic measures of tissue oxygenation and oxygen balance 3.To describe the association between mitoPO2 and vital organ (dis)functions and change of SOFA (Sequential organ failure assessment) score after 24hrs 5. To describe the microcirculatory, cellular and mitochondrial function during the first 24 hours of septic patients. Study population: critically ill patients with sepsis which are admitted to the intensive care unit through the emergency department or hospital ward and in whom fluid therapy (crystalloid, albumin and red cell transfusion) is planned. Main study endpoints Primary endpoint: Change in mitoPO2 after fluid therapy. This will be compared to traditional parameters used to measure oxygenation and oxygen balance Secondary endpoints: Association of mitoPO2 trend with separate (ischemic) organ (dis)function. The SOFA score after 24 hours will also be assessed. Safety of mitoPO2 measurements in critically ill septic patients. Description of the association of sepsis with microcirculatory function, cellular function and mitochondrial function. Description of the association between mitoPO2 change and clinical outcomes , like length of stay(both ICU and in-hospital) and mortality (both ICU and in-hospital).
Tracking Information
- NCT #
- NCT03842722
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Johanna G van der Bom, MD, PhD Leiden University Medical Center and Sanquin Research Leiden Principal Investigator: M S Arbous, MD, PhD Leiden University Medical Center