Systemic Inflammatory Response Syndrome (SIRS)BCSSNCT02871895
Application of Biomarkers Change to Predict Outcome of Patient With Severe Sepsis
An observational study of Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of severe sepsis and septic shock, as well as strategies for bedside implementation. The treatment recommendations were organized in two bundles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at Kaohsiung Chang Gung Memorial Hospital. All adult patients presenting with sepsis or severe sepsis will be enrolled on admission to medical intensive units (total 34 beds). Sepsis and severe sepsis are defined as American College of Chest Physicians/Society of Critical Care Medicine consensus criteria for sepsis syndromes.
Who may be able to join
- Severe sepsis
- Septic shock
Who cannot join
- Patients are < 18 yrs
- Patients are immunocompromised (treatment with corticosteroids >1 mg/kg equivalent prednisone)
- Bone marrow or organ transplant recipients,
- Leucopenia [white blood cells count< 109/L] or neutropenia [polymorphonuclear granulocyte count <0.5 109/L]
- Hematologic malignancy
- Acquired immune deficiency syndrome
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kaohsiung City
ChiHan Huang, Bachelor, 886 077317123 ext. 2858, cheryl60286@gmail.com
About this study
Official title: Application of Biomarkers Change to Predict Outcome of Patients With Severe Sepsis
In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of severe sepsis and septic shock, as well as strategies for bedside implementation. The treatment recommendations were organized in two bundles. In an international study, enrolling adult patients with severe sepsis admitted to these intensive care units, investigators found that while mortality from severe sepsis is high (44.5%), compliance with resuscitation and management bundles is generally poor in much of Asia. Investigators need to identify the patients at risk for high in-hospital mortality in order to take appropriate steps.
From their past studies, investigators found that sepsis involved inflammation and coagulation. The multiple organ involvement was associated with interaction of novel biomarkers such as cytokines. There is limited data regarding comparing and application of biomarkers of different characteristic on sepsis treatment. A simultaneous detection of multiple cytokines may provide significant prognostic information. For other biomarkers, promising observation data have been put forward, but their potential needs to be evaluated in large-scale, well-designed prospective intervention studies before clinical use can be recommended. Besides many clinical studies on biomarkers were confounded by its lack of standard bundle care for severe sepsis patient.
Read more
Here investigators performed a systematic study aimed at evaluating
- the individual and combined diagnostic accuracy of biomarkers for predicting mortality;
- whether trend change in biomarker level more useful for above prediction;
- which biomarker or biomarker combination checked can predict patients at risk of evolving with severe organ dysfunctions.
Read the detailed description
Variables will be tested for their association with the outcome using Pearson chi-square test for categorical data and Mann-Whitney U test for numerical data. Comparison the different groups will be conducted by using Mann-Whitney U test for numerical data and using Pearson chi-square test for categorical data. The time course of biomarker plasma levels will be assessed by analysis of variance. Multivariate analysis will be performed using a logistic regression model to estimate the odds ratio of organ failure and dying, along with the 95% confidence interval (CI). Forward and backward selection procedures will be used to iteratively select the variables potentially related to death.
Discrimination will be assessed using the area under the receiver operating characteristic curve to evaluate how well the model distinguished patients who lived from those who died and whether progression of organ dysfunction. A survival analysis will be performed using Kaplan-Meier curves and the log-rank test. Analyses will be completed and a two-tailed p<0.05 will be considered significant.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock, Multiple Organ Failure
- Keywords
- sepsis, severe sepsis, septic shock, multiple organ failure
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Shock, Septic, Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of immune dysfunction score to predict 28-day mortality of sepsis patients
Several existing scoring systems developed for mortality prediction, such as APACHE II and Sequential Organ Failure Assessment score (SOFA score). However, none of these take immune dysfunction status into account. With a substantial degree of heterogeneity in the sepsis response ranging from cytokines storm to immunoparalysis, better patient stratification is needed. Investigators aimed to develop and validate a scoring system (minimum:0 to maximum:6 scores) that can determine patients' immune dysfunction status related to outcomes.
Measured: baseline and 4 weeks, up to 24 weeks
Secondary outcomes (2)
Deteriorated dynamic acute kidney injury (AKI) stage associated with immune dysfunction and higher mortality in Septic Patients Admitted to Intensive Care Unit
A series of inflammatory cytokines participated into the mechanism and associated with the severity and worsening of AKI. We assumed the dynamic change of the AKI containing even better predictive value rather than evaluating the AKI in a single time point. We categorized septic patients into 4 groups based on the variation of AKI stage. In addition to mortality comparison, we also made an investigation to the relationships of immune cytokines in those sepsis patients.
Measured: baseline and 4 weeks, up to 24 weeks
To determine whether delta pulse pressure at day 3 compared with day 1 affect survival outcomes in patients who were diagnosed sepsis and septic shock.
Pulse pressure is the difference between the systolic and diastolic blood pressures. It arises from the interaction of cardiac ejection and the properties of the arterial circulation. A wide pulse pressure is associated with increased cardiovascular mortality. However, a widened pulse pressure was suggested as a potential prognostic indicator of decreased mortality in patients with sepsis in a retrospective electronic medical record review. In clinical practice, pulse pressure variation can help predict fluid responsiveness in patients. Furthermore, we sought to determine whether stratification of septic patients according to the changes of pulse pressure (value of pulse pressure at day 3 minus value of pulse pressure at day 1) and status of whether still in need of vasopressor at day 3 could help predict survival. The host immune response to sepsis during progression may play an important role.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJul 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Feng Fang, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871895
- Sponsor's protocol ID
- CMRPG8B1063
- Acronym
- BCSS
- Status last verified
- Jun 2018
- First submitted
- 1 Sep 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Neveu H, Kleinknecht D, Brivet F, Loirat P, Landais P. Prognostic factors in acute renal failure due to sepsis. Results of a prospective multicentre study. The French Study Group on Acute Renal Failure. Nephrol Dial Transplant. 1996 Feb;11(2):293-9. doi: 10.1093/oxfordjournals.ndt.a027256.
PubMed 8700363Vincent JL, Abraham E, Annane D, Bernard G, Rivers E, Van den Berghe G. Reducing mortality in sepsis: new directions. Crit Care. 2002 Dec;6 Suppl 3(Suppl 3):S1-18. doi: 10.1186/cc1860. Epub 2002 Dec 5.
PubMed 12720570Salluh JI, Bozza PT. Biomarkers of sepsis: lost in translation? Crit Care Med. 2008 Jul;36(7):2192-4. doi: 10.1097/CCM.0b013e31817c0cd8. No abstract available.
PubMed 18594226Shiramizo SC, Marra AR, Durao MS, Paes AT, Edmond MB, Pavao dos Santos OF. Decreasing mortality in severe sepsis and septic shock patients by implementing a sepsis bundle in a hospital setting. PLoS One. 2011;6(11):e26790. doi: 10.1371/journal.pone.0026790. Epub 2011 Nov 3.
PubMed 22073193Nguyen HB, Corbett SW, Steele R, Banta J, Clark RT, Hayes SR, Edwards J, Cho TW, Wittlake WA. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med. 2007 Apr;35(4):1105-12. doi: 10.1097/01.CCM.0000259463.33848.3D.
PubMed 17334251Phua J, Koh Y, Du B, Tang YQ, Divatia JV, Tan CC, Gomersall CD, Faruq MO, Shrestha BR, Gia Binh N, Arabi YM, Salahuddin N, Wahyuprajitno B, Tu ML, Wahab AY, Hameed AA, Nishimura M, Procyshyn M, Chan YH; MOSAICS Study Group. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011 Jun 13;342:d3245. doi: 10.1136/bmj.d3245.
PubMed 21669950Jones AE, Puskarich MA. Is lactate the "Holy Grail" of biomarkers for sepsis prognosis? Crit Care Med. 2009 May;37(5):1812-3. doi: 10.1097/CCM.0b013e3181a09487. No abstract available.
PubMed 19373056Schuetz P, Haubitz S, Mueller B. Do sepsis biomarkers in the emergency room allow transition from bundled sepsis care to personalized patient care? Curr Opin Crit Care. 2012 Aug;18(4):341-9. doi: 10.1097/MCC.0b013e328354b2c8.
PubMed 22610364Kwak SH, Wang XQ, He Q, Fang WF, Mitra S, Bdeir K, Ploplis VA, Xu Z, Idell S, Cines D, Abraham E. Plasminogen activator inhibitor-1 potentiates LPS-induced neutrophil activation through a JNK-mediated pathway. Thromb Haemost. 2006 May;95(5):829-35.
PubMed 16676075Wang XQ, Bdeir K, Yarovoi S, Cines DB, Fang W, Abraham E. Involvement of the urokinase kringle domain in lipopolysaccharide-induced acute lung injury. J Immunol. 2006 Oct 15;177(8):5550-7. doi: 10.4049/jimmunol.177.8.5550.
PubMed 17015742Hoke TS, Douglas IS, Klein CL, He Z, Fang W, Thurman JM, Tao Y, Dursun B, Voelkel NF, Edelstein CL, Faubel S. Acute renal failure after bilateral nephrectomy is associated with cytokine-mediated pulmonary injury. J Am Soc Nephrol. 2007 Jan;18(1):155-64. doi: 10.1681/ASN.2006050494. Epub 2006 Dec 13.
PubMed 17167117Lin MC, Leung SY, Fang WF, Chin CH, Chung KF. Down-regulation of insulin-like growth factor I (IGF-I) in the mouse diaphragm during sepsis. Chang Gung Med J. 2010 Sep-Oct;33(5):501-8.
PubMed 20979700
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Biomarkers Change to Predict Outcome of Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT02871895
- Acronym / sponsor ID
- BCSS / CMRPG8B1063
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock, Multiple Organ Failure
- Keywords
- sepsis, severe sepsis, septic shock, multiple organ failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Aug 2016 (estimated)
- 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.
In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of severe sepsis and septic shock, as well as strategies for bedside implementation. The treatment recommendations were organized in two bundles. In an international study, enrolling adult patients with severe sepsis admitted to these intensive care units, investigators found that while mortality from severe sepsis is high (44.5%), compliance with resuscitation and management bundles is generally poor in much of Asia. Investigators need to identify the patients at risk for high in-hospital mortality in order to take appropriate steps.
From their past studies, investigators found that sepsis involved inflammation and coagulation. The multiple organ involvement was associated with interaction of novel biomarkers such as cytokines. There is limited data regarding comparing and application of biomarkers of different characteristic on sepsis treatment. A simultaneous detection of multiple cytokines may provide significant prognostic information. For other biomarkers, promising observation data have been put forward, but their potential needs to be evaluated in large-scale, well-designed prospective intervention studies before clinical use can be recommended. Besides many clinical studies on biomarkers were confounded by its lack of standard bundle care for severe sepsis patient.
Here investigators performed a systematic study aimed at evaluating
- the individual and combined diagnostic accuracy of biomarkers for predicting mortality;
- whether trend change in biomarker level more useful for above prediction;
- which biomarker or biomarker combination checked can predict patients at risk of evolving with severe organ dysfunctions.
Detailed description
Variables will be tested for their association with the outcome using Pearson chi-square test for categorical data and Mann-Whitney U test for numerical data. Comparison the different groups will be conducted by using Mann-Whitney U test for numerical data and using Pearson chi-square test for categorical data. The time course of biomarker plasma levels will be assessed by analysis of variance. Multivariate analysis will be performed using a logistic regression model to estimate the odds ratio of organ failure and dying, along with the 95% confidence interval (CI). Forward and backward selection procedures will be used to iteratively select the variables potentially related to death.
Discrimination will be assessed using the area under the receiver operating characteristic curve to evaluate how well the model distinguished patients who lived from those who died and whether progression of organ dysfunction. A survival analysis will be performed using Kaplan-Meier curves and the log-rank test. Analyses will be completed and a two-tailed p<0.05 will be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at Kaohsiung Chang Gung Memorial Hospital. All adult patients presenting with sepsis or severe sepsis will be enrolled on admission to medical intensive units (total 34 beds). Sepsis and severe sepsis are defined as American College of Chest Physicians/Society of Critical Care Medicine consensus criteria for sepsis syndromes.
Key inclusion criteria (2 listed)
- Severe sepsis
- Septic shock
Key exclusion criteria (6 listed)
- Patients are < 18 yrs
- Patients are immunocompromised (treatment with corticosteroids >1 mg/kg equivalent prednisone)
- Bone marrow or organ transplant recipients,
- Leucopenia [white blood cells count< 109/L] or neutropenia [polymorphonuclear granulocyte count <0.5 109/L]
- Hematologic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of immune dysfunction score to predict 28-day mortality of sepsis patients
Time frame: baseline and 4 weeks, up to 24 weeks
Several existing scoring systems developed for mortality prediction, such as APACHE II and Sequential Organ Failure Assessment score (SOFA score). However, none of these take immune dysfunction status into account. With a substantial degree of heterogeneity in the sepsis response ranging from cytokines storm to immunoparalysis, better patient stratification is needed. Investigators aimed to develop and validate a scoring system (minimum:0 to maximum:6 scores) that can determine patients' immune dysfunction status related to outcomes.
2 secondary outcomes
Deteriorated dynamic acute kidney injury (AKI) stage associated with immune dysfunction and higher mortality in Septic Patients Admitted to Intensive Care Unit
Time frame: baseline and 4 weeks, up to 24 weeks
To determine whether delta pulse pressure at day 3 compared with day 1 affect survival outcomes in patients who were diagnosed sepsis and septic shock.
Time frame: baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Results publication: PubMed 8700363Neveu H, Kleinknecht D, Brivet F, Loirat P, Landais P. Prognostic factors in acute renal failure due to sepsis. Results of a prospective multicentre study. The French Study Group on Acute Renal Failure. Nephrol Dial Transplant. 1996 Feb;11(2):293-9. doi: 10.1093/oxfordjournals.ndt.a027256.
- Results publication: PubMed 12720570Vincent JL, Abraham E, Annane D, Bernard G, Rivers E, Van den Berghe G. Reducing mortality in sepsis: new directions. Crit Care. 2002 Dec;6 Suppl 3(Suppl 3):S1-18. doi: 10.1186/cc1860. Epub 2002 Dec 5.
- Results publication: PubMed 18594226Salluh JI, Bozza PT. Biomarkers of sepsis: lost in translation? Crit Care Med. 2008 Jul;36(7):2192-4. doi: 10.1097/CCM.0b013e31817c0cd8. No abstract available.
- Results publication: PubMed 22073193Shiramizo SC, Marra AR, Durao MS, Paes AT, Edmond MB, Pavao dos Santos OF. Decreasing mortality in severe sepsis and septic shock patients by implementing a sepsis bundle in a hospital setting. PLoS One. 2011;6(11):e26790. doi: 10.1371/journal.pone.0026790. Epub 2011 Nov 3.
- Results publication: PubMed 17334251Nguyen HB, Corbett SW, Steele R, Banta J, Clark RT, Hayes SR, Edwards J, Cho TW, Wittlake WA. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med. 2007 Apr;35(4):1105-12. doi: 10.1097/01.CCM.0000259463.33848.3D.
- Results publication: PubMed 21669950Phua J, Koh Y, Du B, Tang YQ, Divatia JV, Tan CC, Gomersall CD, Faruq MO, Shrestha BR, Gia Binh N, Arabi YM, Salahuddin N, Wahyuprajitno B, Tu ML, Wahab AY, Hameed AA, Nishimura M, Procyshyn M, Chan YH; MOSAICS Study Group. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011 Jun 13;342:d3245. doi: 10.1136/bmj.d3245.
- Results publication: PubMed 19373056Jones AE, Puskarich MA. Is lactate the "Holy Grail" of biomarkers for sepsis prognosis? Crit Care Med. 2009 May;37(5):1812-3. doi: 10.1097/CCM.0b013e3181a09487. No abstract available.
- Results publication: PubMed 22610364Schuetz P, Haubitz S, Mueller B. Do sepsis biomarkers in the emergency room allow transition from bundled sepsis care to personalized patient care? Curr Opin Crit Care. 2012 Aug;18(4):341-9. doi: 10.1097/MCC.0b013e328354b2c8.
- Results publication: PubMed 16676075Kwak SH, Wang XQ, He Q, Fang WF, Mitra S, Bdeir K, Ploplis VA, Xu Z, Idell S, Cines D, Abraham E. Plasminogen activator inhibitor-1 potentiates LPS-induced neutrophil activation through a JNK-mediated pathway. Thromb Haemost. 2006 May;95(5):829-35.
- Results publication: PubMed 17015742Wang XQ, Bdeir K, Yarovoi S, Cines DB, Fang W, Abraham E. Involvement of the urokinase kringle domain in lipopolysaccharide-induced acute lung injury. J Immunol. 2006 Oct 15;177(8):5550-7. doi: 10.4049/jimmunol.177.8.5550.
- Results publication: PubMed 17167117Hoke TS, Douglas IS, Klein CL, He Z, Fang W, Thurman JM, Tao Y, Dursun B, Voelkel NF, Edelstein CL, Faubel S. Acute renal failure after bilateral nephrectomy is associated with cytokine-mediated pulmonary injury. J Am Soc Nephrol. 2007 Jan;18(1):155-64. doi: 10.1681/ASN.2006050494. Epub 2006 Dec 13.
- Results publication: PubMed 20979700Lin MC, Leung SY, Fang WF, Chin CH, Chung KF. Down-regulation of insulin-like growth factor I (IGF-I) in the mouse diaphragm during sepsis. Chang Gung Med J. 2010 Sep-Oct;33(5):501-8.
- Individual participant dataSharing planned: Undecided
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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.
Wen-Feng Fang, M.D. principal investigator
Chang Gung Memorial Hospital
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 Systemic Inflammatory Response Syndrome (SIRS) and Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChiHan Huang, Bachelor (886 077317123 ext. 2858, cheryl60286@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of immune dysfunction score to predict 28-day mortality of sepsis patients (time frame: baseline and 4 weeks, up to 24 weeks). 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 NCT02871895, which also lists 12 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 18 Jul 2018.