The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

Sepsis Clinical Trial

Official title:

The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973829
• Other study ID #: 12-007998
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test whether the health care provider access and training in CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate timely and error free best-practice delivery and minimize preventable death and costly complications in critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5215
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

All adult (= 18 years) patients admitted for the first time to the participating ICUs will be included.

Exclusion:

Not critically Ill, admitted for low risk monitoring, planned ICU admissions for routine postoperative surveillance for less than 24 hours after uncomplicated surgery, readmission and transferred from outside ICU.

Related Conditions & MeSH terms

• Bleeding
• Coma
• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Shock
• Trauma

Intervention

Other:
• Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
This study is about training and implementation of best critical care practices in the international ICUs with variable resources facilitated by access to a specifically designed electronic checklist

Locations

Country	Name	City	State
Belarus	Gomel Regional Clinical Hospital	Gomel
Bosnia and Herzegovina	University Hospital Banja Luka	Banja Luka
Bosnia and Herzegovina	Sveucilišna klinicka bolnica	Mostar
Bosnia and Herzegovina	Prim.Dr. Abdulah Nakaš	Sarajevo
Brazil	Hospital Israelita Albert Einstein	Sao Paulo
China	Beijing Hospital	Beijing
China	Guang An Men Hospital	Beijing
China	China West China Hospital	Chengdu
China	1st Affiliated Hospital of Guangzhou Medical University	Guangzhusi
China	Anhui Province Hospital	Hefei
China	China Shanghai Changhai Hospital	Shanghai
China	Tianjin First Center Hospital	Tianjin
Croatia	KBC Rijeka	Rijeka
Dominican Republic	Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT	Santo Domingo
India	Kasturba Hospital	Manial	Karnataka
India	Lok Nayak Hospital	New Delhi	Delhi
India	Ispat General Hospital	Raurkela	Odisha
Ireland	St James Hosptial	Dublin
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)	Mexico City
Mongolia	Central State University Hospital	Ulaanbaatar
Pakistan	Shaukat Khanum Memorial Cancer Hospital and Research Center	Lahore
Philippines	St. Luke's Medical Center	Manila
Philippines	The Med City Hospital	Manila
Poland	Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznan	Poznan
Saudi Arabia	King Abdulaziz Medical City,	Riyadh
Serbia	Military Medical Academy	Belgrade
Serbia	The Institute for pulmonary diseases of Vojvodina	Sremska Kamenica
Turkey	Akdeniz University Hospital	Antalya
Turkey	Gulhane Military Medical Faculty	Antalya
Uganda	International hospital Kampala	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Countries where clinical trial is conducted

Belarus,  Bosnia and Herzegovina,  Brazil,  China,  Croatia,  Dominican Republic,  India,  Ireland,  Mexico,  Mongolia,  Pakistan,  Philippines,  Poland,  Saudi Arabia,  Serbia,  Turkey,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to best critical care practices	Adherence to best practice in initial evaluation and treatment of critically ill medical and surgical patients Appropriate shock resuscitation Appropriate sepsis treatment Appropriate mechanical ventilation Appropriate peptic ulcer, deep vein thrombosis and infectious disease prophylaxis	Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Primary	ICU and hospital lengths of stay	Patient will be followed till they get discharged from hospital for whatever length they stay.	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Mortality for 4 weeks	Patient will be followed for 4 weeks and hospital discharge(up to total 10 weeks post discharge)	Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge)

External Links

•   education and introduction website