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

NCT01973829 | Completed

• 1 other identifier: 12-007998
• Study Type: interventional
• Target: 5,215
• Locations: 17 countries
• Sites: 30

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.

Conditions

Critical Illness; Sepsis; Respiratory Failure; Shock; Coma; Bleeding; Trauma

Keywords

CERTAIN, Checklist, ICU, Outcome, Adults

Outcome Measures

Primary Outcomes (2)

• 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

  Participants will be followed for the duration of ICU stay, an expected average of 2 weeks

• ICU and hospital lengths of stay

  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 Outcomes (1)

• Mortality for 4 weeks

  Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge)

Study Arms (1)

Baseline arm

OTHER

baseline data (50 patients or 3 months per center)

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

Interventions

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

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

Also known as: Checklist

Baseline arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult (≥ 18 years) patients admitted for the first time to the participating ICUs will be included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (30)

Gomel Regional Clinical Hospital

Homyel, Belarus

Location

University Hospital Banja Luka

Banja Luka, Bosnia and Herzegovina

Location

Sveučilišna klinička bolnica

Mostar, Bosnia and Herzegovina

Location

Prim.Dr. Abdulah Nakaš

Sarajevo, Bosnia and Herzegovina

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Beijing Hospital

Beijing, China

Location

Guang An Men Hospital

Beijing, China

Location

China West China Hospital

Chengdu, China

Location

1st Affiliated Hospital of Guangzhou Medical University

Guangzhusi, China

Location

Anhui Province Hospital

Hefei, China

Location

China Shanghai Changhai Hospital

Shanghai, China

Location

Tianjin First Center Hospital

Tianjin, China

Location

KBC Rijeka

Rijeka, Croatia

Location

Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT

Santo Domingo, Dominican Republic

Location

Kasturba Hospital

Manial, Karnataka, India

Location

Lok Nayak Hospital

New Delhi, National Capital Territory of Delhi, India

Location

Ispat General Hospital

Raurkela, Odisha, India

Location

St James Hosptial

Dublin, Ireland

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

Mexico City, Mexico

Location

Central State University Hospital

Ulaanbaatar, Mongolia

Location

Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Pakistan

Location

St. Luke's Medical Center

Manila, Philippines

Location

The Med City Hospital

Manila, Philippines

Location

Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań

Poznan, Poland

Location

King Abdulaziz Medical City,

Riyadh, Saudi Arabia

Location

Military Medical Academy

Belgrade, Serbia

Location

The Institute for pulmonary diseases of Vojvodina

Kamenitz, Serbia

Location

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

Location

Gulhane Military Medical Faculty

Antalya, Turkey (Türkiye)

Location

International hospital Kampala

Kampala, Uganda

Location

Related Publications (2)

• Tekin A, Swart P, Flurin L, Vukoja M, Kashyap R, Schultz MJ, Gajic O, Dong Y; CERTAIN investigators of the Society of Critical Care Medicine Discovery Network. The Weekend Effect on Evidence-Based Care Adherence Before and After Implementation of Checklist-Based Care in the Intensive Care Unit: A Multinational Study. J Intensive Care Med. 2025 Nov 24:8850666251396016. doi: 10.1177/08850666251396016. Online ahead of print.

  PMID: 41284657 DERIVED

• 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.

  PMID: 33729718 DERIVED

Related Links

• education and introduction website

MeSH Terms

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency; Shock; Coma; Hemorrhage; Wounds and Injuries

Interventions

Checklist; Association

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders; Respiratory Tract Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ognjen Gajic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Marija Kojicic, MD

  Institute for Pulmonary Diseases, Novi Sad, Serbia

  PRINCIPAL INVESTIGATOR

• Rahul Kashyap, MD

  Mayo Clinic

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Yue Dong, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CONS-CRITICAL CARE

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 1, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

IE (1); BR (1); PH (2); BO (3); BE (1); SA (1); SE (2); MO (1); CN (7); PA (1); IN (3); CR (1); DO (1); UG (1); ME (1); PL (1); TU (2)