Insufficient Oxygenation in Septic Patients

NCT03842722 | Completed

• 1 other identifier: NL64824.058.18
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Critical Care; Mitochondria; Oxygen; Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• Change of mitoPO2 during first 24 hours of a septic patient

  The primary endpoint is the change of mitoPO2(mitochondrial oxygenation) before and after fluid therapy in patients with sepsis. This will be compared to traditional parameters used to measure tissue oxygenation and oxygen balance (central venous oxygen saturation, mean arterial pressure and lactate).

  24 hours

Secondary Outcomes (8)

• SOFA (sequential organ failure assessment) score after 24 hours

  24 hours

• Organ (dis)function

  24 hours

• Validation of mitoPO2 measurement with blood based biomarkers of cellular function

  24 hours

• Safety (incidence of adverse and serious adverse events)

  24 hours

• Length of ICU stay

  3 months

Study Arms (1)

Critically ill septic patients

Cohort: patients admitted via the emergency department or hospital ward to the intensive care unit of Leiden University Medical Center with the diagnosis sepsis or septic shock, who receive fluid therapy (either colloid, crystalloid and/or red blood cell) in their first day of admission to the ICU.

Device: Protoporphyrin IX - Triplet State Lifetime Technique

Interventions

Protoporphyrin IX - Triplet State Lifetime Technique DEVICE

Protoporphyrin IX - Triplet State Lifetime Technique is a way to measure mitochondrial oxygen tension in a non-invasive way at bedside.

Critically ill septic patients

Eligibility Criteria

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

Study Population

Patients in the emergency department or hospital ward admitted to the Intensive Care Unit of the Leiden University Medical Center with (the suspicion of) sepsis will be the source population of the study. Leiden Univesity Medical Center is an academic hospital. Septic patients are identified as specified in the Dutch protocol of sepsis identification and management in the emergency department. It consists of having clinical suspicion of sepsis in combination with the at least 2 of the following symptoms: ≥ 20 breaths per minute, heart frequency \> 90 beats per minute, leukocytes \> 12x109 or leukocytes \< 4x10\^9, and/or temperature \> 38 °C or \<36 °C

You may qualify if:

• Age of patient is at least 18 years
• Patients diagnosed with sepsis in the emergency department or hospital ward
• Patients are admitted to the ICU via the hospital ward or emergency department
• Informed consent is given either by the patient or if the patient is too ill to give informed consent, by his or her legal representative.
• Patients have an arterial catheter in situ, since blood samples will be taken for the study. Most patients admitted to the ICU have an arterial catheter in place since it is part of standard care.

You may not qualify if:

• Patients younger than 18 years
• Patients with sepsis discharged after emergency department visit
• Patients admitted to a hospital ward other than the ICU after emergency department visit
• Patients who cannot give informed consent themselves and without a legal representative will be excluded since no informed consent can be obtained
• Patients known with porphyria and/or photodermatosis will be excluded, since the risk of phototoxicity
• Patients with hypersensitivity to the active substance or to the plaster material of ALA (5-aminolevulinic acid)
• Pregnant or breast feeding women since there is no adequate data form the use of ALA in pregnant or breast feeding women
• Insufficient comprehensibility of the Dutch language

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken for measurement of: creatinine, hemoglobin, lactate, central venous oxygen saturation, arterial saturation, arterial oxygen tension, venous oxygen tension, central venous-to-arterial carbon dioxide partial pressure difference. Furthermore, blood based cellular function will be assessed (presence of reactive oxygen species molecules, mitochondrial membrane potential and glutathione activity).

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Johanna G van der Bom, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• M S Arbous, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager clinical transfusion research

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: February 15, 2019
• Study Start: February 13, 2019
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)