Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

NCT01804764 | Completed DMC

• 1 other identifier: IX/001137-23/12/2010
• Study Type: observational
• Target: 1,123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Sepsis

Keywords

Severe Sepsis; Septic Shock; Sepsis Six bundle

Outcome Measures

Primary Outcomes (1)

• An improvement in Sepsis Six Bundle implementation for Severe Sepsis and Septic Shock

  within 12 months after an Educational and Organizational Intervention

Secondary Outcomes (1)

• All cause Mortality

  1 month afte diagnosis of Severe Sepsis / Septic Shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the Emergency Department out-patients and the Medical Wards in -patients presenting with suspected svere sepsis or septic shock

You may qualify if:

• Any patient having a SIRS due to Sepsis and at least on of the following criteria: Systolic Blood Pressure \< 90 mmHg and/or serum lactate \> 4 mg/dl and/or organ failure

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Niguarda Ca' Granda Hospital

Milan, Italy

Location

Related Publications (9)

• Cardoso T, Carneiro AH, Ribeiro O, Teixeira-Pinto A, Costa-Pereira A. Reducing mortality in severe sepsis with the implementation of a core 6-hour bundle: results from the Portuguese community-acquired sepsis study (SACiUCI study). Crit Care. 2010;14(3):R83. doi: 10.1186/cc9008. Epub 2010 May 10.

  PMID: 20459716 BACKGROUND

• Micek ST, Roubinian N, Heuring T, Bode M, Williams J, Harrison C, Murphy T, Prentice D, Ruoff BE, Kollef MH. Before-after study of a standardized hospital order set for the management of septic shock. Crit Care Med. 2006 Nov;34(11):2707-13. doi: 10.1097/01.CCM.0000241151.25426.D7.

  PMID: 16943733 BACKGROUND

• Thiel SW, Asghar MF, Micek ST, Reichley RM, Doherty JA, Kollef MH. Hospital-wide impact of a standardized order set for the management of bacteremic severe sepsis. Crit Care Med. 2009 Mar;37(3):819-24. doi: 10.1097/CCM.0b013e318196206b.

  PMID: 19237883 BACKGROUND

• Funk D, Sebat F, Kumar A. A systems approach to the early recognition and rapid administration of best practice therapy in sepsis and septic shock. Curr Opin Crit Care. 2009 Aug;15(4):301-7. doi: 10.1097/MCC.0b013e32832e3825.

  PMID: 19561493 BACKGROUND

• Girardis M, Rinaldi L, Donno L, Marietta M, Codeluppi M, Marchegiano P, Venturelli C; Sopravvivere alla Sepsi Group of the Modena-University Hospital. Effects on management and outcome of severe sepsis and septic shock patients admitted to the intensive care unit after implementation of a sepsis program: a pilot study. Crit Care. 2009;13(5):R143. doi: 10.1186/cc8029. Epub 2009 Sep 3.

  PMID: 19728879 BACKGROUND

• Cronshaw HL, Daniels R, Bleetman A, Joynes E, Sheils M. Impact of the Surviving Sepsis Campaign on the recognition and management of severe sepsis in the emergency department: are we failing? Emerg Med J. 2011 Aug;28(8):670-5. doi: 10.1136/emj.2009.089581. Epub 2010 Jul 26.

  PMID: 20660901 BACKGROUND

• Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.

  PMID: 18158437 BACKGROUND

• Talan DA, Moran GJ, Abrahamian FM. Severe sepsis and septic shock in the emergency department. Infect Dis Clin North Am. 2008 Mar;22(1):1-31, v. doi: 10.1016/j.idc.2007.09.005.

  PMID: 18295681 BACKGROUND

• Ferrer R, Artigas A, Levy MM, Blanco J, Gonzalez-Diaz G, Garnacho-Montero J, Ibanez J, Palencia E, Quintana M, de la Torre-Prados MV; Edusepsis Study Group. Improvement in process of care and outcome after a multicenter severe sepsis educational program in Spain. JAMA. 2008 May 21;299(19):2294-303. doi: 10.1001/jama.299.19.2294.

  PMID: 18492971 BACKGROUND

Related Links

• Surviving Sepsis Campaign Guidelines

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sergio Vesconi, MD

  Niguarda Ca' Granda Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: May 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

IT (1)