Sepsis, SevereIPSEPSISNCT04163705
Immune Profile of Patients With Sepsis
An observational study of Sepsis, Severe, run by Hospital El Cruce.
Trial summary
The immune response can acquire different profiles (proinflammatory and anti-inflammatory response) depending on the activating agent.The objective of this study is to compare the immunological profile in patients with severe sepsis and positive blood cultures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis, Severe
- What is being tested?
- blood sample collection
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Jul 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis and positive blood cultures will be included prospectively, within 24 hours of diagnosis of sepsis.
Who may be able to join
None listed.
Who cannot join
- VIH immunosuppression Autoimmune disease Neoplasm Pregnant women Cirrhosis Bone Marrow Disease Malnutrition.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immune Profile of Patients With Positive Blood Cultures and Multiple Organ Dysfunctions
The immune response can acquire different profiles (proinflammatory and anti-inflammatory response) depending on the activating agent.The objective of this study is to compare the immunological profile in patients with severe sepsis and positive blood cultures.
Read the detailed description
Sepsis is one of the leading causes of death in patients admitted to intensive care. It is characterized by being an exaggerated and deregulated inflammatory response triggered by an infection. Although inflammation affects the compartmentalization of the infection, the activation of the immune system in sepsis has a systemic problem, which sometimes affects the organs distant from the site of infection. Within this context, two processes are recognized, which can often coexist: the pro-inflammatory response and the anti-inflammatory response. While it is assumed that the proinflammatory response may favor the development of multiple organ failure, sepsis-induced immunosuppression would favor a new infection, especially of endogenous and intranosocomial germs, mortality increases. The pro-anti-inflammatory nature of sepsis (if so can be defined) depends on a multitude of factors: the type of infection, personal history, genetic conditions, associated diseases, environmental factors, the use of immunosuppressive medications and nutrition. state, among others. Recent studies found that the immune response profile differs depending on the type of infection (Gram negative or Gram positive). Defining the predominant immune condition is not a simple task. Here there are no commonly used clinical variables that define the immune status, except for neutrophil counts.
Objetive:
- Define whether there are differences in the immunological profile between patients with sepsis and positive blood cultures by Gram negative and Gram positive.
- Identify easily accessible clinical and / or laboratory patterns that can predict the predominant immune character.
Design: The study was approved by the Scientific and Ethics committee of the institution. Informed consent will be requested.
Patients with severe sepsis and positive blood cultures will be included prospectively, within 24 hours of diagnosis of sepsis.
Consider severe sepsis to life-threatening organic dysfunction caused by a deregulated host response to infection. This concept includes at least a score of the SOFA (sequential evaluation of organic insufficiency) scale equal to or greater than 2 points The presence of one or more positive samples will be considered positive blood cultures.
Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed.
Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative.
Patients with severe sepsis but with negative blood cultures will be considered a control group. In patients with positive blood cultures, new blood samples will be taken between days 3 to 5 of sample 0 to define the evolution of the pro and anti-inflammatory response.
Minimum 12 patients per group will be included. The level of proinflammatory cytokines (TNF alpha and IL 1) and anti-inflammatory (IL10 and IL1 receptor) will be measured by ELISA method. Finally, the data will be analyzed and the differences between patients with Gram-positive and Gram-negative infections will be established.
Primary Outcome Measure:
Measurement of the pro-inflammatory and anti-inflammatory response in patients with severe sepsis and positive blood cultures
- Conditions
- Sepsis, Severe
- Being tested
- blood sample collection
- Keywords
- Multiple organ dysfunctions
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionDiagnostic test
Routine Laboratory Analysis
| Study group | Role | What they receive |
|---|---|---|
| Gram negative | The presence of one or more positive samples will be considered positive blood cultures.
Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed.
Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative. Receives: Diagnostic Test: blood sample collection | |
| Gram positive | The presence of one or more positive samples will be considered positive blood cultures.
Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed.
Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative. Receives: Diagnostic Test: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proinflammatory response.
Plasma level comparison of: TNF-alpha, IL-6 and IL-1 between both groups, by flow cytometry.
Measured: Six months
Comparison of the anti-inflammatory response
Plasma level comparison of: TNF-alpha receptor, INF-gamma and IL-10 between both groups, by flow cytometry.
Measured: Six months
Secondary outcomes (2)
Mortality comparison
Mortality between both groups will be compared for the 28th day of admission to the protocol.
Measured: Six months
SOFA score comparison
Multiple organ dysfunction will be measured with the SOFA score at the time of admission to the protocol and between days 3 to 5. The severity score will be compared between groups.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sepsis, SevereStudies 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
- 40 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Nestor Pistillo, MD, Principal investigator, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163705
- Sponsor's protocol ID
- Hospital El Cruce
- Acronym
- IPSEPSIS
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
PubMed 23353941Gotts JE, Matthay MA. Sepsis: pathophysiology and clinical management. BMJ. 2016 May 23;353:i1585. doi: 10.1136/bmj.i1585.
PubMed 27217054Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PubMed 23480440Zeni F, Vindimian M, Pain P, Gery P, Tardy B, Bertrand JC. Antiinflammatory and proinflammatory cytokines in patients with severe sepsis. J Infect Dis. 1995 Oct;172(4):1171-2. doi: 10.1093/infdis/172.4.1171. No abstract available.
PubMed 7561209Endo S, Inada K, Inoue Y, Kuwata Y, Suzuki M, Yamashita H, Hoshi S, Yoshida M. Two types of septic shock classified by the plasma levels of cytokines and endotoxin. Circ Shock. 1992 Dec;38(4):264-74.
PubMed 1292890Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.
PubMed 15639681Minasyan H. Sepsis and septic shock: Pathogenesis and treatment perspectives. J Crit Care. 2017 Aug;40:229-242. doi: 10.1016/j.jcrc.2017.04.015. Epub 2017 Apr 18.
PubMed 28448952Guenter CA, Hinshaw LB. Comparison of septic shock due to gram-negative and gram-positive organisms. Proc Soc Exp Biol Med. 1970 Jul;134(3):780-3. doi: 10.3181/00379727-134-34882. No abstract available.
PubMed 4988179Janols H, Bergenfelz C, Allaoui R, Larsson AM, Ryden L, Bjornsson S, Janciauskiene S, Wullt M, Bredberg A, Leandersson K. A high frequency of MDSCs in sepsis patients, with the granulocytic subtype dominating in gram-positive cases. J Leukoc Biol. 2014 Nov;96(5):685-93. doi: 10.1189/jlb.5HI0214-074R. Epub 2014 Jun 13.
PubMed 24929004
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profile of Patients With Positive Blood Cultures and Multiple Organ Dysfunctions
- ClinicalTrials.gov ID
- NCT04163705
- Acronym / sponsor ID
- IPSEPSIS / Hospital El Cruce
- Conditions
- Sepsis, Severe
- Keywords
- Multiple organ dysfunctions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 15 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.
The immune response can acquire different profiles (proinflammatory and anti-inflammatory response) depending on the activating agent.The objective of this study is to compare the immunological profile in patients with severe sepsis and positive blood cultures.
Detailed description
Sepsis is one of the leading causes of death in patients admitted to intensive care. It is characterized by being an exaggerated and deregulated inflammatory response triggered by an infection. Although inflammation affects the compartmentalization of the infection, the activation of the immune system in sepsis has a systemic problem, which sometimes affects the organs distant from the site of infection. Within this context, two processes are recognized, which can often coexist: the pro-inflammatory response and the anti-inflammatory response. While it is assumed that the proinflammatory response may favor the development of multiple organ failure, sepsis-induced immunosuppression would favor a new infection, especially of endogenous and intranosocomial germs, mortality increases. The pro-anti-inflammatory nature of sepsis (if so can be defined) depends on a multitude of factors: the type of infection, personal history, genetic conditions, associated diseases, environmental factors, the use of immunosuppressive medications and nutrition. state, among others. Recent studies found that the immune response profile differs depending on the type of infection (Gram negative or Gram positive). Defining the predominant immune condition is not a simple task. Here there are no commonly used clinical variables that define the immune status, except for neutrophil counts.
Objetive:
- Define whether there are differences in the immunological profile between patients with sepsis and positive blood cultures by Gram negative and Gram positive.
- Identify easily accessible clinical and / or laboratory patterns that can predict the predominant immune character.
Design: The study was approved by the Scientific and Ethics committee of the institution. Informed consent will be requested.
Patients with severe sepsis and positive blood cultures will be included prospectively, within 24 hours of diagnosis of sepsis.
Consider severe sepsis to life-threatening organic dysfunction caused by a deregulated host response to infection. This concept includes at least a score of the SOFA (sequential evaluation of organic insufficiency) scale equal to or greater than 2 points The presence of one or more positive samples will be considered positive blood cultures.
Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed.
Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative.
Patients with severe sepsis but with negative blood cultures will be considered a control group. In patients with positive blood cultures, new blood samples will be taken between days 3 to 5 of sample 0 to define the evolution of the pro and anti-inflammatory response.
Minimum 12 patients per group will be included. The level of proinflammatory cytokines (TNF alpha and IL 1) and anti-inflammatory (IL10 and IL1 receptor) will be measured by ELISA method. Finally, the data will be analyzed and the differences between patients with Gram-positive and Gram-negative infections will be established.
Primary Outcome Measure:
Measurement of the pro-inflammatory and anti-inflammatory response in patients with severe sepsis and positive blood cultures
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gram negative | – | Diagnostic Test: blood sample collectionThe presence of one or more positive samples will be considered positive blood cultures. Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed. Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative. |
| Gram positive | – | Diagnostic Test: blood sample collectionThe presence of one or more positive samples will be considered positive blood cultures. Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed. Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis and positive blood cultures will be included prospectively, within 24 hours of diagnosis of sepsis.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- VIH immunosuppression Autoimmune disease Neoplasm Pregnant women Cirrhosis Bone Marrow Disease Malnutrition.
- -
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 sample collectionRoutine Laboratory Analysis | Diagnostic test | Gram negative, Gram positive |
Primary outcome
Comparison of the proinflammatory response.
Time frame: Six months
Plasma level comparison of: TNF-alpha, IL-6 and IL-1 between both groups, by flow cytometry.
Comparison of the anti-inflammatory response
Time frame: Six months
Plasma level comparison of: TNF-alpha receptor, INF-gamma and IL-10 between both groups, by flow cytometry.
2 secondary outcomes
Mortality comparison
Time frame: Six months
SOFA score comparison
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Background: PubMed 23353941Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
- Background: PubMed 27217054Gotts JE, Matthay MA. Sepsis: pathophysiology and clinical management. BMJ. 2016 May 23;353:i1585. doi: 10.1136/bmj.i1585.
- Background: PubMed 23480440Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
- Background: PubMed 7561209Zeni F, Vindimian M, Pain P, Gery P, Tardy B, Bertrand JC. Antiinflammatory and proinflammatory cytokines in patients with severe sepsis. J Infect Dis. 1995 Oct;172(4):1171-2. doi: 10.1093/infdis/172.4.1171. No abstract available.
- Background: PubMed 1292890Endo S, Inada K, Inoue Y, Kuwata Y, Suzuki M, Yamashita H, Hoshi S, Yoshida M. Two types of septic shock classified by the plasma levels of cytokines and endotoxin. Circ Shock. 1992 Dec;38(4):264-74.
- Background: PubMed 15639681Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.
- Background: PubMed 28448952Minasyan H. Sepsis and septic shock: Pathogenesis and treatment perspectives. J Crit Care. 2017 Aug;40:229-242. doi: 10.1016/j.jcrc.2017.04.015. Epub 2017 Apr 18.
- Background: PubMed 4988179Guenter CA, Hinshaw LB. Comparison of septic shock due to gram-negative and gram-positive organisms. Proc Soc Exp Biol Med. 1970 Jul;134(3):780-3. doi: 10.3181/00379727-134-34882. No abstract available.
- Results publication: PubMed 24929004Janols H, Bergenfelz C, Allaoui R, Larsson AM, Ryden L, Bjornsson S, Janciauskiene S, Wullt M, Bredberg A, Leandersson K. A high frequency of MDSCs in sepsis patients, with the granulocytic subtype dominating in gram-positive cases. J Leukoc Biol. 2014 Nov;96(5):685-93. doi: 10.1189/jlb.5HI0214-074R. Epub 2014 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Sepsis, Severe
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
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.
Nestor Pistillo, MD principal investigator
Hospital El Cruce
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, Severe, run by Hospital El Cruce.
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 0 inclusion and 2 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Nestor Pistillo, MD (54-011 4210-9000 ext. 5636, npistillo@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proinflammatory response. (time frame: Six months). The study lists 2 primary outcomes in all. 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 NCT04163705, which also lists 9 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 Nov 2019.