Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04163705
Study type Observational [Patient Registry]
Source Hospital El Cruce
Contact Nestor Pistillo, MD
Phone 54-011 4210-9000
Email npistillo@yahoo.com.ar
Status Not yet recruiting
Phase
Start date December 1, 2019
Completion date July 1, 2020

See also
  Status Clinical Trial Phase
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Recruiting NCT04796636 - High-dose Intravenous Vitamin C in Patients With Septic Shock Phase 1
Terminated NCT04134624 - EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock N/A
Withdrawn NCT04821414 - Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children
Recruiting NCT05357339 - Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock N/A
Recruiting NCT06178822 - Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
Completed NCT04833621 - Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW? N/A
Not yet recruiting NCT04105400 - Procalcitonin in Diagnosis of Sepsis in Critically Ill Patient
Completed NCT04459572 - As an Early Indicator Biomarker of Prognosis and Mortality in Children With Sepsis and Septic Shock: suPAR N/A
Completed NCT04508296 - The Effect pf Goal-directed De-escalation in ARDS on Organ Function and Mortality N/A
Recruiting NCT03685214 - Comparison of Balanced Crystalloids and Normal Saline in Septic Patients N/A
Not yet recruiting NCT04850456 - Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
Completed NCT04747795 - Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments Phase 3
Terminated NCT03821038 - Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients Phase 2
Completed NCT05246969 - Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
Recruiting NCT05442710 - Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy Phase 2
Completed NCT05467605 - Effect of Probiotics on Cytokines in Sepsis in Children N/A
Completed NCT03974386 - Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock N/A
Recruiting NCT04203979 - Sepsis: From Syndrome to Personalized Care
Not yet recruiting NCT03367026 - Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine N/A