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

November 18, 2019 updated by: Mayang Indah Lestari, Universitas Sriwijaya

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30126
        • Mohammad Hoesin Central General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Resuscitation room and ICU

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sriwijaya

Collaborators

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2019

Primary Completion (ACTUAL)

August 20, 2019

Study Completion (ACTUAL)

August 20, 2019

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 047/kepkrsmhfkunsri/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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