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

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ClinicalTrials.gov Identifier: NCT04169412
Recruitment Status : Completed
First Posted : November 19, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Mayang Indah Lestari, Universitas Sriwijaya

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

Condition or disease Intervention/treatment
Sepsis Diagnostic Test: Blood Collection

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™
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Resuscitation Failure, Protein Carbonyl and Receptor Interacting Protein Kinase 3 as Mortality Predictor in Septic Patient
Actual Study Start Date : February 22, 2019
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Resuscitation Failure, High PCO Level, High RIPK3 Level
  1. Resuscitation failure was defined as lactate level ≥2 mmol/L or lactate reduction <20% hour-4 after initial sepsis recognition.
  2. High PCO level was defined as PCO level ≥ cut off point.
  3. High RIPK3 level was defined as PCO level ≥ cut off point.
 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.)
Resuscitation Success, Low PCO Level, Low RIPK3 Level
  1. Resuscitation success was defined as lactate level <2 mmol/L or lactate reduction ≥20% hour-4 after initial sepsis recognition.
  2. Low PCO level was defined as PCO level < cut off point.
  3. Low RIPK3 level was defined as PCO level < cut off point.
 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.)


Outcome Measures
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Primary Outcome Measures :
  1. The Ability of Resuscitation Failure, Protein Carbonyl (PCO) and Receptor Interacting Protein Kinase 3 (RIPK3) for Predicting Mortality in Septic Patients [ Time Frame: 28 days ]
    Probability of Mortality in Septic Patients with Resuscitation Failure, High PCO Level and High RIPK3 Level


Secondary Outcome Measures :
  1. How Sensitive and Specific Protein Carbonyl (PCO) Level for Predicting Mortality in Septic Patients? [ Time Frame: 28 days ]
    Sensitivity and Specificity of PCO Level for Predicting Mortality in Septic Patients

  2. How Sensitive and Specific Receptor Interacting Protein Kinase 3 (RIPK3) Level for Predicting Mortality in Septic Patients? [ Time Frame: 28 days ]
    Sensitivity and Specificity of RIPK3 Level for Predicting Mortality in Septic Patients


Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Resuscitation room and ICU
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169412


Locations
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Indonesia
Mohammad Hoesin Central General Hospital
Palembang, South Sumatera, Indonesia, 30126
Sponsors and Collaborators
Universitas Sriwijaya
Indonesia University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Mayang Indah Lestari, Principal Investigator, Universitas Sriwijaya
ClinicalTrials.gov Identifier: NCT04169412    
Other Study ID Numbers: 047/kepkrsmhfkunsri/2019
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No