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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01973829
First received: October 23, 2013
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Critical Illness
Sepsis
Respiratory Failure
Shock
Coma
Bleeding
Trauma
Other: Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Adherence to best critical care practices [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    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

  • ICU and hospital lengths of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks ] [ Designated as safety issue: No ]
    Patient will be followed till they get discharged from hospital for whatever length they stay.


Secondary Outcome Measures:
  • Mortality for 4 weeks [ Time Frame: Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge) ] [ Designated as safety issue: No ]
    Patient will be followed for 4 weeks and hospital discharge(up to total 10 weeks post discharge)


Estimated Enrollment: 15000
Study Start Date: November 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline arm
Baseline data collection (3 months or 50 patients per ICU)
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
Other Name: Checklist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973829

Locations
Bosnia and Herzegovina
Sveučilišna klinička bolnica Recruiting
Mostar, Bosnia and Herzegovina
Contact: Mateo Paric, MD       mateo.peric@gmail.com   
Contact: Dragana Vladic, MD         
Sveučilišna klinička bolnica Recruiting
Mostar, Bosnia and Herzegovina
Contact: Dajana Vladic, MD       daki.vladic@hotmail.com   
Contact: Dragana Markotić, MD       drag_m@live.com   
Brazil
Hospital Israelita Albert Einstein Recruiting
Sao Paulo, Brazil
Contact: Antonio Capone Neto, MD       antonio.cneto@einstein.br   
Contact: Leonardo Rocha, MD       lrocha23@gmail.com   
China
Guang An Men Hospital Recruiting
Beijing, China
Contact: Zhao Xin, MD       echo0111@sina.com   
Principal Investigator: Zhao Xin, MD         
Tianjin First Center Hospital Recruiting
Tianjin, China
Contact: Hongmei Gao, MD       ghm182@163.com   
Contact: Lin Dou, MD       doulint@163.com   
Dominican Republic
Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT Recruiting
Santo Domingo, Dominican Republic
Contact: Rafael Tolentino       rtolentino@cedimat.net   
Principal Investigator: Rafael Tolentino, MD         
India
Ispat General Hospital Recruiting
Rourkela, India
Contact: Rajyabardhan Pattnaik, MD       rajyabardhan@gmail.com   
Principal Investigator: Rajyabardhan Pattnaik, MD         
Ireland
St James Hosptial Recruiting
Dublin, Ireland
Contact: Ignacio Martin-Loeches, MD       drmartinloeches@gmail.com   
Contact: Zieta O Hagan, RN       ZOHogan@stjames.ie   
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) Recruiting
Mexico City, Mexico
Contact: Gustavo Barraza       gustavobarraza@hotmail.com   
Principal Investigator: Guillermo Domínguez-Cherit, MD         
Mongolia
Central State University Hospital Recruiting
Ulaanbaatar, Mongolia
Contact: Otgontuya Gombo       g_otgontuya@yahoo.com   
Principal Investigator: Ganbold Lundeg, MD         
Saudi Arabia
King Abdulaziz Medical City, Recruiting
Riyadh, Saudi Arabia
Contact: Yaseen Arabi, MD       yassenarabi@yahoo.com   
Contact: Shihab Mundekkadan, RN       mundekkadansh@NGHA.MED.SA   
Serbia
Military Medical Academy Recruiting
Belgrade, Serbia
Contact: Maja Surbatovic, MD       maja.surbatovic@gmail.com   
Principal Investigator: Maja Surbatovic, MD         
The Institute for pulmonary diseases of Vojvodina Recruiting
Sremska Kamenica, Serbia
Contact: Marija Vukoja, MD       kojicic.marija@gmail.com   
Contact: Jovan Matijasevic, MD       jovanmat99@yahoo.com   
Principal Investigator: Marija Vukoja, MD         
Turkey
Akdeniz University Hospital Recruiting
Antalya, Turkey
Contact: Atilla Ramazanoglu, MD       atilla.ramazanoglu@gmail.com   
Contact: Aysen Erdogan, MD       aydoganer@gmail.com   
Gulhane Military Medical Faculty Recruiting
Antalya, Turkey
Contact: Oguz Kilickaya, MD       drokkaya@gmail.com   
Uganda
International hospital Kampala Recruiting
Kampala, Uganda
Contact: Arthur Kwitzera, MD       kwizera.arthur@gmail.com   
Principal Investigator: Arthur Kwitzera, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ognjen Gajic, MD Mayo Clinic
Principal Investigator: Marija Kojicic, MD Institute for Pulmonary Diseases, Novi Sad, Serbia
Study Director: Rahul Kashyap, MD Mayo Clinic
Principal Investigator: Marcus Schultz, MD VU University of Amsterdam
Principal Investigator: Michelle N Gong, MD Montefiore Medical Center, New York USA
Principal Investigator: Oguz Kilickaya, MD Gulhane Military Medical Faculty, Ankara, Turkey
Principal Investigator: Neill Adhikari, MD University of Toronto, Toronto Canada
Principal Investigator: Linda Bucher, PhD College of Health Sciences, University of Delavere, Delawere USA
Principal Investigator: Daniel Talmor, MD Beth Israel Deakoness Medical Center, Boston USA
  More Information

Additional Information:
No publications provided

Responsible Party: Ognjen Gajic, CONS-CRITICAL CARE, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01973829     History of Changes
Other Study ID Numbers: 12-007998
Study First Received: October 23, 2013
Last Updated: February 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
CERTAIN, Checklist, ICU, Outcome, Adults

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 02, 2015