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

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ClinicalTrials.gov Identifier: NCT01973829
Recruitment Status : Recruiting
First Posted : November 1, 2013
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
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)
Study Start Date : November 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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)


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: November 1, 2013    Key Record Dates
Last Update Posted: January 9, 2018
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