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

This study is currently recruiting participants.
Verified March 2017 by Ognjen Gajic, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01973829
First Posted: November 1, 2013
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic
  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: Intervention Model: Single Group Assignment
Masking: None (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 Ognjen Gajic, 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 ]
    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 ]
    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) ]
    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: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Checklist

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973829


Contacts
Contact: Rahul Kashyap, MD kashyap.rahul@mayo.edu
Contact: Yue Dong, MD dong.yue@mayo.edu

  Show 30 Study Locations
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 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
  More Information

Additional Information:
Responsible Party: Ognjen Gajic, CONS-CRITICAL CARE, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01973829     History of Changes
Other Study ID Numbers: 12-007998
First Submitted: October 23, 2013
First Posted: November 1, 2013
Last Update Posted: March 22, 2017
Last Verified: March 2017

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

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