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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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