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

Primary Purpose

Critical Illness, Sepsis, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring CERTAIN, Checklist, ICU, Outcome, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gomel Regional Clinical Hospital
  • University Hospital Banja Luka
  • Sveučilišna klinička bolnica
  • Prim.Dr. Abdulah Nakaš
  • Hospital Israelita Albert Einstein
  • Beijing Hospital
  • Guang An Men Hospital
  • China West China Hospital
  • 1st Affiliated Hospital of Guangzhou Medical University
  • Anhui Province Hospital
  • China Shanghai Changhai Hospital
  • Tianjin First Center Hospital
  • KBC Rijeka
  • Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT
  • Lok Nayak Hospital
  • Kasturba Hospital
  • Ispat General Hospital
  • St James Hosptial
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
  • Central State University Hospital
  • Shaukat Khanum Memorial Cancer Hospital and Research Center
  • St. Luke's Medical Center
  • The Med City Hospital
  • Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań
  • King Abdulaziz Medical City,
  • Military Medical Academy
  • The Institute for pulmonary diseases of Vojvodina
  • Akdeniz University Hospital
  • Gulhane Military Medical Faculty
  • International hospital Kampala

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Baseline arm

Arm Description

baseline data (50 patients or 3 months per center)

Outcomes

Primary Outcome Measures

Adherence to best critical care practices
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
Patient will be followed till they get discharged from hospital for whatever length they stay.

Secondary Outcome Measures

Mortality for 4 weeks
Patient will be followed for 4 weeks and hospital discharge(up to total 10 weeks post discharge)

Full Information

First Posted
October 23, 2013
Last Updated
August 16, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01973829
Brief Title
The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Official Title
The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sepsis, Respiratory Failure, Shock, Coma, Bleeding, Trauma
Keywords
CERTAIN, Checklist, ICU, Outcome, Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline arm
Arm Type
Other
Arm Description
baseline data (50 patients or 3 months per center)
Intervention Type
Other
Intervention Name(s)
Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
Other Intervention Name(s)
Checklist
Intervention Description
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
Primary Outcome Measure Information:
Title
Adherence to best critical care practices
Description
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
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Title
ICU and hospital lengths of stay
Description
Patient will be followed till they get discharged from hospital for whatever length they stay.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary Outcome Measure Information:
Title
Mortality for 4 weeks
Description
Patient will be followed for 4 weeks and hospital discharge(up to total 10 weeks post discharge)
Time Frame
Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ognjen Gajic, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marija Kojicic, MD
Organizational Affiliation
Institute for Pulmonary Diseases, Novi Sad, Serbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahul Kashyap, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcus Schultz, MD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle N Gong, MD
Organizational Affiliation
Montefiore Medical Center, New York USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oguz Kilickaya, MD
Organizational Affiliation
Gulhane Military Medical Faculty, Ankara, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neill Adhikari, MD
Organizational Affiliation
University of Toronto, Toronto Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Bucher, PhD
Organizational Affiliation
College of Health Sciences, University of Delavere, Delawere USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Talmor, MD
Organizational Affiliation
Beth Israel Deakoness Medical Center, Boston USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yue Dong, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
Country
Belarus
Facility Name
University Hospital Banja Luka
City
Banja Luka
Country
Bosnia and Herzegovina
Facility Name
Sveučilišna klinička bolnica
City
Mostar
Country
Bosnia and Herzegovina
Facility Name
Prim.Dr. Abdulah Nakaš
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
Country
Brazil
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Guang An Men Hospital
City
Beijing
Country
China
Facility Name
China West China Hospital
City
Chengdu
Country
China
Facility Name
1st Affiliated Hospital of Guangzhou Medical University
City
Guangzhusi
Country
China
Facility Name
Anhui Province Hospital
City
Hefei
Country
China
Facility Name
China Shanghai Changhai Hospital
City
Shanghai
Country
China
Facility Name
Tianjin First Center Hospital
City
Tianjin
Country
China
Facility Name
KBC Rijeka
City
Rijeka
Country
Croatia
Facility Name
Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT
City
Santo Domingo
Country
Dominican Republic
Facility Name
Lok Nayak Hospital
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
Kasturba Hospital
City
Manial
State/Province
Karnataka
Country
India
Facility Name
Ispat General Hospital
City
Raurkela
State/Province
Odisha
Country
India
Facility Name
St James Hosptial
City
Dublin
Country
Ireland
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
City
Mexico City
Country
Mexico
Facility Name
Central State University Hospital
City
Ulaanbaatar
Country
Mongolia
Facility Name
Shaukat Khanum Memorial Cancer Hospital and Research Center
City
Lahore
Country
Pakistan
Facility Name
St. Luke's Medical Center
City
Manila
Country
Philippines
Facility Name
The Med City Hospital
City
Manila
Country
Philippines
Facility Name
Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań
City
Poznan
Country
Poland
Facility Name
King Abdulaziz Medical City,
City
Riyadh
Country
Saudi Arabia
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Facility Name
The Institute for pulmonary diseases of Vojvodina
City
Sremska Kamenica
Country
Serbia
Facility Name
Akdeniz University Hospital
City
Antalya
Country
Turkey
Facility Name
Gulhane Military Medical Faculty
City
Antalya
Country
Turkey
Facility Name
International hospital Kampala
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
33729718
Citation
Vukoja M, Dong Y, Adhikari NKJ, Schultz MJ, Arabi YM, Martin-Loeches I, Hache M, Gavrilovic S, Kashyap R, Gajic O; Checklist for Early Recognition and Treatment of Acute Illness and Injury (CERTAIN) Investigators of the SCCM Discovery Network. Checklist for Early Recognition and Treatment of Acute Illness and Injury: An Exploratory Multicenter International Quality-Improvement Study in the ICUs With Variable Resources. Crit Care Med. 2021 Jun 1;49(6):e598-e612. doi: 10.1097/CCM.0000000000004937.
Results Reference
derived
Links:
URL
http://icertain.org/
Description
education and introduction website

Learn more about this trial

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

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