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

August 16, 2018 updated by: Ognjen Gajic, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Baseline arm
baseline data (50 patients or 3 months per center)
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 Names:
  • Checklist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to best critical care practices
Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
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
ICU and hospital lengths of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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, 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
  • Study Director: Yue Dong, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-007998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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