Resuscitation Failure, Oxidative Stress, and Necroptosis as Mortality Predictor in Septic Patient

Sepsis Clinical Trial

Official title:

Resuscitation Failure, Protein Carbonyl and Receptor Interacting Protein Kinase 3 as Mortality Predictor in Septic Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169412
• Other study ID #: 047/kepkrsmhfkunsri/2019
• Status: Completed
• Start date: February 22, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: November 2019
• Source: Universitas Sriwijaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

Diagnostic Test:
• Blood Collection
Blood Gas Analysis using Stat Profile pHOx® Series (nova biomedical, Waltham, U.S.) and Enzym-linked Immunosorbent Assay (ELISA) using Bio-Rad (Bio-Rad Laboratories, California, U.S.)

Locations

Country	Name	City	State
Indonesia	Mohammad Hoesin Central General Hospital	Palembang	South Sumatera

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Sriwijaya	Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Ability of Resuscitation Failure, Protein Carbonyl (PCO) and Receptor Interacting Protein Kinase 3 (RIPK3) for Predicting Mortality in Septic Patients	Probability of Mortality in Septic Patients with Resuscitation Failure, High PCO Level and High RIPK3 Level	28 days
Secondary	How Sensitive and Specific Protein Carbonyl (PCO) Level for Predicting Mortality in Septic Patients?	Sensitivity and Specificity of PCO Level for Predicting Mortality in Septic Patients	28 days
Secondary	How Sensitive and Specific Receptor Interacting Protein Kinase 3 (RIPK3) Level for Predicting Mortality in Septic Patients?	Sensitivity and Specificity of RIPK3 Level for Predicting Mortality in Septic Patients	28 days

External Links

•   Data Reports | Sepsis | CDC