SepsisNCT04169412

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

An observational study of Sepsis, run by Universitas Sriwijaya at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Resuscitation failure, oxidative stress and necroptosis were able to predict mortality in septic patient Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Blood Collection
How many people: 72 participants
Where: 1 siteIndonesia
Study dates: 22 Feb 2019to 20 Aug 2019
How long will I take part?: 28 Days
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: Resuscitation room and ICU

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Mohammad Hoesin Central General Hospital
Palembang, South Sumatera, 30126

Other trials in Indonesia

About this study

Official title: 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

Read the 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™

Conditions: Sepsis
Being tested: Blood Collection
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood CollectionDiagnostic test
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.)

Study groups in NCT04169412
Study group	Role	What they receive
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. Receives: Diagnostic Test: Blood Collection
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. Receives: Diagnostic Test: Blood Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 28 days

Secondary outcomes (2)

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
Measured: 28 days
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
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 201920 Aug 2019

First posted19 Nov 2019
Study start22 Feb 2019
Primary completion20 Aug 2019
Study completion20 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 72 participants (actual)
Target duration: 28 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT04169412
Sponsor's protocol ID: 047/kepkrsmhfkunsri/2019
Status last verified: Nov 2019
First submitted: 17 Nov 2019
Last updated: 20 Nov 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.
PubMed 28903154
Dantes RB, Epstein L. Combatting Sepsis: A Public Health Perspective. Clin Infect Dis. 2018 Sep 28;67(8):1300-1302. doi: 10.1093/cid/ciy342.
PubMed 29846544
Marshall JC, Vincent JL, Guyatt G, Angus DC, Abraham E, Bernard G, Bombardier C, Calandra T, Jorgensen HS, Sylvester R, Boers M. Outcome measures for clinical research in sepsis: a report of the 2nd Cambridge Colloquium of the International Sepsis Forum. Crit Care Med. 2005 Aug;33(8):1708-16. doi: 10.1097/01.ccm.0000174478.70338.03.
PubMed 16096445
Weiss SL, Deutschman CS. Elevated malondialdehyde levels in sepsis - something to 'stress' about? Crit Care. 2014 Mar 19;18(2):125. doi: 10.1186/cc13786.
PubMed 25029036
Weinlich R, Oberst A, Beere HM, Green DR. Necroptosis in development, inflammation and disease. Nat Rev Mol Cell Biol. 2017 Feb;18(2):127-136. doi: 10.1038/nrm.2016.149. Epub 2016 Dec 21.
PubMed 27999438
Duprez L, Takahashi N, Van Hauwermeiren F, Vandendriessche B, Goossens V, Vanden Berghe T, Declercq W, Libert C, Cauwels A, Vandenabeele P. RIP kinase-dependent necrosis drives lethal systemic inflammatory response syndrome. Immunity. 2011 Dec 23;35(6):908-18. doi: 10.1016/j.immuni.2011.09.020.
PubMed 22195746
Levy B. Lactate and shock state: the metabolic view. Curr Opin Crit Care. 2006 Aug;12(4):315-21. doi: 10.1097/01.ccx.0000235208.77450.15.
PubMed 16810041
Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.
PubMed 20463176
Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PubMed 20179283
Yu B, Tian HY, Hu ZJ, Zhao C, Liu LX, Zhang Y, Zhu GJ, Wang LT, Wu XH, Li J. [Comparison of the effect of fluid resuscitation as guided either by lactate clearance rate or by central venous oxygen saturation in patients with sepsis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2013 Oct;25(10):578-83. doi: 10.3760/cma.j.issn.2095-4352.2013.10.002. Chinese.
PubMed 24119693
Mahmoodpoor A, Shadvar K, Saghaleini SH, Koleini E, Hamishehkar H, Ostadi Z, Nader ND. Which one is a better predictor of ICU mortality in septic patients? Comparison between serial serum lactate concentrations and its removal rate. J Crit Care. 2018 Apr;44:51-56. doi: 10.1016/j.jcrc.2017.10.019. Epub 2017 Oct 17.
PubMed 29065350
Mantzarlis K, Tsolaki V, Zakynthinos E. Role of Oxidative Stress and Mitochondrial Dysfunction in Sepsis and Potential Therapies. Oxid Med Cell Longev. 2017;2017:5985209. doi: 10.1155/2017/5985209. Epub 2017 Aug 20.
PubMed 28904739
Galley HF. Oxidative stress and mitochondrial dysfunction in sepsis. Br J Anaesth. 2011 Jul;107(1):57-64. doi: 10.1093/bja/aer093. Epub 2011 May 19.
PubMed 21596843
Costa NA, Gut AL, Azevedo PS, Tanni SE, Cunha NB, Fernandes AAH, Polegato BF, Zornoff LAM, de Paiva SAR, Balbi AL, Ponce D, Minicucci MF. Protein carbonyl concentration as a biomarker for development and mortality in sepsis-induced acute kidney injury. Biosci Rep. 2018 Jan 25;38(1):BSR20171238. doi: 10.1042/BSR20171238. Print 2018 Feb 28.
PubMed 29263144

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Resuscitation Failure, Protein Carbonyl and Receptor Interacting Protein Kinase 3 as Mortality Predictor in Septic Patient
ClinicalTrials.gov ID: NCT04169412
Acronym / sponsor ID: 047/kepkrsmhfkunsri/2019
Conditions: Sepsis
Study type: Observational
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Universitas SriwijayaUniversity, hospital or other
Collaborators: Universitas Indonesia
Study start: 22 Feb 2019 (actual)
Primary completion: 20 Aug 2019 (actual)
Study completion: 20 Aug 2019 (actual)
First posted: 19 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 28 Days
Number of arms: 2

Arm	Type	Receives
Resuscitation Failure, High PCO Level, High RIPK3 Level	–	Diagnostic Test: Blood Collection1. 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.
Resuscitation Success, Low PCO Level, Low RIPK3 Level	–	Diagnostic Test: Blood Collection1. 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.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Resuscitation room and ICU

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood CollectionBlood 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.)	Diagnostic test	Resuscitation Failure, High PCO Level, High RIPK3 Level, Resuscitation Success, Low PCO Level, Low RIPK3 Level

Primary outcome

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

2 secondary outcomes

How Sensitive and Specific Protein Carbonyl (PCO) Level for Predicting Mortality in Septic Patients?
Time frame: 28 days
How Sensitive and Specific Receptor Interacting Protein Kinase 3 (RIPK3) Level for Predicting Mortality in Septic Patients?
Time frame: 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Background: PubMed 28903154Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.
Background: PubMed 29846544Dantes RB, Epstein L. Combatting Sepsis: A Public Health Perspective. Clin Infect Dis. 2018 Sep 28;67(8):1300-1302. doi: 10.1093/cid/ciy342.
Background: PubMed 16096445Marshall JC, Vincent JL, Guyatt G, Angus DC, Abraham E, Bernard G, Bombardier C, Calandra T, Jorgensen HS, Sylvester R, Boers M. Outcome measures for clinical research in sepsis: a report of the 2nd Cambridge Colloquium of the International Sepsis Forum. Crit Care Med. 2005 Aug;33(8):1708-16. doi: 10.1097/01.ccm.0000174478.70338.03.
Background: PubMed 25029036Weiss SL, Deutschman CS. Elevated malondialdehyde levels in sepsis - something to 'stress' about? Crit Care. 2014 Mar 19;18(2):125. doi: 10.1186/cc13786.
Background: PubMed 27999438Weinlich R, Oberst A, Beere HM, Green DR. Necroptosis in development, inflammation and disease. Nat Rev Mol Cell Biol. 2017 Feb;18(2):127-136. doi: 10.1038/nrm.2016.149. Epub 2016 Dec 21.
Background: PubMed 22195746Duprez L, Takahashi N, Van Hauwermeiren F, Vandendriessche B, Goossens V, Vanden Berghe T, Declercq W, Libert C, Cauwels A, Vandenabeele P. RIP kinase-dependent necrosis drives lethal systemic inflammatory response syndrome. Immunity. 2011 Dec 23;35(6):908-18. doi: 10.1016/j.immuni.2011.09.020.
Results publication: PubMed 16810041Levy B. Lactate and shock state: the metabolic view. Curr Opin Crit Care. 2006 Aug;12(4):315-21. doi: 10.1097/01.ccx.0000235208.77450.15.
Results publication: PubMed 20463176Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, Willemsen SP, Bakker J; LACTATE study group. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.
Results publication: PubMed 20179283Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
Results publication: PubMed 24119693Yu B, Tian HY, Hu ZJ, Zhao C, Liu LX, Zhang Y, Zhu GJ, Wang LT, Wu XH, Li J. [Comparison of the effect of fluid resuscitation as guided either by lactate clearance rate or by central venous oxygen saturation in patients with sepsis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2013 Oct;25(10):578-83. doi: 10.3760/cma.j.issn.2095-4352.2013.10.002. Chinese.
Results publication: PubMed 29065350Mahmoodpoor A, Shadvar K, Saghaleini SH, Koleini E, Hamishehkar H, Ostadi Z, Nader ND. Which one is a better predictor of ICU mortality in septic patients? Comparison between serial serum lactate concentrations and its removal rate. J Crit Care. 2018 Apr;44:51-56. doi: 10.1016/j.jcrc.2017.10.019. Epub 2017 Oct 17.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
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RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, run by Universitas Sriwijaya at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04169412, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.