Clinical trial NCT04169412: Resuscitation Failure, Oxidative Stress, and Necroptosis as Mortality Predictor in Septic Patient
Official title: Resuscitation Failure, Protein Carbonyl and Receptor Interacting Protein Kinase 3 as Mortality Predictor in Septic Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2019-11-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resuscitation room and ICU

Brief summary: Resuscitation failure, oxidative stress and necroptosis were able to predict mortality in septic patient

Detailed description: This prospective cohort study was conducted at resuscitation room and ICU of Mohammad Hoesin hospital, a single tertiary teaching hospital in Palembang, South Sumatera. This study was started after ethical and location authorization were unleashed in February to August 2019. Inclusion criteria were patients aged 18 years old or above who met Sepsis-3 definition and diagnosed with sepsis. Exclusion criteria were patients whose family did not give any consent to participate, not treated at the ICU, had a late diagnosis (\>24 h), pregnant, and diagnosed with brain dead. Drop out criteria including patients who died \<4 h after diagnosed and could not be followed in 28 days. Investigators were trained to identified all eligible subjects. All the subjects had a standard resuscitation and their blood was taken to be examined at the laboratory. Subjects were observed in 28 days whether there were any mortality or not. Failed resuscitation defined by examined lactate level ≥ 2 mmol/L or lactate reduction \<20%. Data was statistically analyzed with STATA™

Eligibility criteria: Inclusion Criteria:

* Participants aged 18 years old or above
* Diagnosed sepsis using Sepsis-3 definition

Exclusion Criteria:

* Participants whose family did not give any consent to participate
* Not treated at the ICU
* Had a late diagnosis (\>24 h)
* Pregnant
* Brain dead

Primary outcomes:
measure: The Ability of Resuscitation Failure, Protein Carbonyl (PCO) and Receptor Interacting Protein Kinase 3 (RIPK3) for Predicting Mortality in Septic Patients
timeFrame: 28 days
Secondary outcomes:
measure: How Sensitive and Specific Protein Carbonyl (PCO) Level for Predicting Mortality in Septic Patients?
timeFrame: 28 days
measure: How Sensitive and Specific Receptor Interacting Protein Kinase 3 (RIPK3) Level for Predicting Mortality in Septic Patients?
timeFrame: 28 days
Other outcomes:
Locations:
city: Palembang
country: Indonesia
facility: Mohammad Hoesin Central General Hospital
state: South Sumatera
Study officials:
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