Insufficient Oxygenation in Septic Patients — INOX-SEPSIS  

Sepsis Clinical Trial

Official title: Insufficient Oxygenation in Septic Patients

Status Completed

Clinical Trial Summary

This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. The mitoPO2 will be measured on prespecified measurement moments in the ICU. With each measurement moment, arterial and central venous blood gasses will be taken too.

Clinical Trial 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 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). ;

Related Conditions & MeSH terms

• Critical Care
• Fluid Therapy
• Mitochondria
• Oxygen
• Sepsis

• NCT number: NCT03842722
• Study type: Observational
• Source: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
• Status: Completed
• Start date: February 13, 2019
• Completion date: September 28, 2023