Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

Status Completed

Clinical Trial Summary

Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis Campaign (SSC) recommends a first 6 hours "resuscitative bundle" to improve patient's outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of the guidelines and several difficulties in their clinical implementation. In recognition of this, a "sepsis six" bundle is designed to facilitate early intervention with just three diagnostic and three therapeutic steps to be delivered by staff within 1 h. The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI) could improve septic patient's outcome in no Critical Care Units. The second endpoint is to evaluate if the compliance to the "sepsis six" bundle could improve after this sort of intervention.

Clinical Trial Description

Methods 39 Medical Wards and 12 Emergency Departments, belonging to 12 hospitals, were voluntarily enrolled. Through the collaboration of 12 Multidisciplinary Teams (MT), we took a Pre-EOI picture of the human resources (i.e. doctors to patients ratio) and of the organisational structures (i.e. laboratory's opening hours) of each hospital. For six months, each unit enrolled was asked to fill in a Clinical Checklist for every patient suspected for severe sepsis or septic shock; so that the Pre-EOI "sepsis six" bundle compliance could be evaluated. Then, we planned several pre-agreed educational meetings for all of the doctors and nurses belonging to the enrolled wards. In the meanwhile the MT worked to overcome any impediment to a better septic patient management. Finally, the educated medical staff was asked to fill in again the same Clinical Checklist used in the Pre-EOI phase; so that the Post-EOI "sepsis six" bundle compliance could be evaluated and a comparison with the Pre-EOI phase could be done. Hypothesis This is the first study aimed to analyze the impact of an Educational and Organizational Intervention in the outcome of septic patients managed in no Critical Care Units. We guess that the differences showed in human resources and organizational structures among the hospitals could have a role in the "sepsis six" bundle compliance and in the patient's outcome, but only a comparison with data collected from the clinical checklist and patient's outcome will confirm our guess. Likewise, we believe that an educational intervention could improve the septic patient's management, but we need the Post-EOI phase conclusion to demonstrate or not our hypothesis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01804764
Study type	Observational
Source	University of Milano Bicocca
Contact
Status	Completed
Phase
Start date	May 2011
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04804306` - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Completed	`NCT02539147` - Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis	N/A
Completed	`NCT01929772` - German Lactat Clearance in Severe Sepsis	N/A
Completed	`NCT01932814` - Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful?	N/A
Completed	`NCT01449721` - Preemptive Resuscitation for Eradication of Septic Shock	N/A
Active, not recruiting	`NCT01162109` - Zinc Therapy in Critical Illness	Phase 1
Not yet recruiting	`NCT01211899` - 4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock	N/A
Completed	`NCT00934011` - Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections	N/A
Recruiting	`NCT00335907` - Protocol-driven Hemodynamic Support for Patients With Septic Shock	N/A
Completed	`NCT00463645` - Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients	N/A
Completed	`NCT02361528` - GM-CSF to Decrease ICU Acquired Infections	Phase 3
Completed	`NCT02734550` - (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis	N/A
Completed	`NCT02973243` - The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III	N/A
Terminated	`NCT03895853` - Early Metabolic Resuscitation for Septic Shock	Phase 2
Completed	`NCT01945983` - Early Use of Norepinephrine in Septic Shock Resuscitation	N/A
Completed	`NCT01598831` - Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy	Phase 3
Enrolling by invitation	`NCT02258984` - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial	N/A