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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01973829
Other study ID # 12-007998
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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