Clinical trial NCT01973829: The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Official title: The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Sepsis
Respiratory Failure
Shock
Coma
Bleeding
Trauma
Keywords: CERTAIN, Checklist, ICU, Outcome, Adults
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 5215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to best critical care practices
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
measure: ICU and hospital lengths of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary outcomes:
measure: Mortality for 4 weeks
timeFrame: Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge)
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Hospital
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Hospital Banja Luka
city: Mostar
country: Bosnia and Herzegovina
facility: Sveučilišna klinička bolnica
city: Sarajevo
country: Bosnia and Herzegovina
facility: Prim.Dr. Abdulah Nakaš
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Guang An Men Hospital
city: Chengdu
country: China
facility: China West China Hospital
city: Guangzhusi
country: China
facility: 1st Affiliated Hospital of Guangzhou Medical University
city: Hefei
country: China
facility: Anhui Province Hospital
city: Shanghai
country: China
facility: China Shanghai Changhai Hospital
city: Tianjin
country: China
facility: Tianjin First Center Hospital
city: Rijeka
country: Croatia
facility: KBC Rijeka
city: Santo Domingo
country: Dominican Republic
facility: Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT
city: New Delhi
country: India
facility: Lok Nayak Hospital
state: Delhi
city: Manial
country: India
facility: Kasturba Hospital
state: Karnataka
city: Raurkela
country: India
facility: Ispat General Hospital
state: Odisha
city: Dublin
country: Ireland
facility: St James Hosptial
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
city: Ulaanbaatar
country: Mongolia
facility: Central State University Hospital
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital and Research Center
city: Manila
country: Philippines
facility: St. Luke's Medical Center
city: Manila
country: Philippines
facility: The Med City Hospital
city: Poznan
country: Poland
facility: Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City,
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Sremska Kamenica
country: Serbia
facility: The Institute for pulmonary diseases of Vojvodina
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
city: Antalya
country: Turkey
facility: Gulhane Military Medical Faculty
city: Kampala
country: Uganda
facility: International hospital Kampala
Study officials:
affiliation: Mayo Clinic
name: Ognjen Gajic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Pulmonary Diseases, Novi Sad, Serbia
name: Marija Kojicic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Rahul Kashyap, MD
role: STUDY_DIRECTOR
affiliation: University of Amsterdam
name: Marcus Schultz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center, New York USA
name: Michelle N Gong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulhane Military Medical Faculty, Ankara, Turkey
name: Oguz Kilickaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Toronto Canada
name: Neill Adhikari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Health Sciences, University of Delavere, Delawere USA
name: Linda Bucher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deakoness Medical Center, Boston USA
name: Daniel Talmor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Yue Dong, MD
role: STUDY_DIRECTOR
References:
citation: Vukoja M, Dong Y, Adhikari NKJ, Schultz MJ, Arabi YM, Martin-Loeches I, Hache M, Gavrilovic S, Kashyap R, Gajic O; Checklist for Early Recognition and Treatment of Acute Illness and Injury (CERTAIN) Investigators of the SCCM Discovery Network. Checklist for Early Recognition and Treatment of Acute Illness and Injury: An Exploratory Multicenter International Quality-Improvement Study in the ICUs With Variable Resources. Crit Care Med. 2021 Jun 1;49(6):e598-e612. doi: 10.1097/CCM.0000000000004937.