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CompletedNCT01973829Updated Aug 20, 2018

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

An interventional study of Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN) in Critical Illness, Sepsis and Respiratory Failure, sponsored by Mayo Clinic. Completed at 30 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.

Primary conditionSepsisRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sepsis
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
5,215
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • CERTAIN, Checklist, ICU, Outcome, Adults
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In context

Sepsis Reclassified

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's enrollment of 5,215 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Compared within Sepsis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5,215 participants (actual)

Study arms

  • Other
    Baseline arm

    baseline data (50 patients or 3 months per center)

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

Interventions

  • OtherChecklist 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

    Also known as: Checklist

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What researchers measure

Primary outcomes

  1. 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

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

  2. ICU and hospital lengths of stay

    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 outcomes

  1. Mortality for 4 weeks

    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)

07

Study locations

30 sites
  • Gomel Regional Clinical Hospital
    Gomel, Belarus
  • University Hospital Banja Luka
    Banja Luka, Bosnia and Herzegovina
  • Sveučilišna klinička bolnica
    Mostar, Bosnia and Herzegovina
  • Prim.Dr. Abdulah Nakaš
    Sarajevo, Bosnia and Herzegovina
  • Hospital Israelita Albert Einstein
    Sao Paulo, Brazil
  • Beijing Hospital
    Beijing, China
  • Guang An Men Hospital
    Beijing, China
  • China West China Hospital
    Chengdu, China
  • 1st Affiliated Hospital of Guangzhou Medical University
    Guangzhusi, China
  • Anhui Province Hospital
    Hefei, China
  • China Shanghai Changhai Hospital
    Shanghai, China
  • Tianjin First Center Hospital
    Tianjin, China
  • KBC Rijeka
    Rijeka, Croatia
  • Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT
    Santo Domingo, Dominican Republic
  • Lok Nayak Hospital
    New Delhi, Delhi, India
  • Kasturba Hospital
    Manial, Karnataka, India
  • Ispat General Hospital
    Raurkela, Odisha, India
  • St James Hosptial
    Dublin, Ireland
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
    Mexico City, Mexico
  • Central State University Hospital
    Ulaanbaatar, Mongolia
  • Shaukat Khanum Memorial Cancer Hospital and Research Center
    Lahore, Pakistan
  • St. Luke's Medical Center
    Manila, Philippines
  • The Med City Hospital
    Manila, Philippines
  • Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań
    Poznan, Poland
  • King Abdulaziz Medical City,
    Riyadh, Saudi Arabia
  • Military Medical Academy
    Belgrade, Serbia
  • The Institute for pulmonary diseases of Vojvodina
    Sremska Kamenica, Serbia
  • Akdeniz University Hospital
    Antalya, Turkey
  • Gulhane Military Medical Faculty
    Antalya, Turkey
  • International hospital Kampala
    Kampala, Uganda
08

References and documents

Publications

  • 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. PubMed 33729718 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01973829
Lead sponsor
Mayo Clinic
Responsible party
Ognjen Gajic (CONS-CRITICAL CARE, Mayo Clinic) — Principal investigator
First posted
Nov 1, 2013
Start date
Nov 2013
Primary completion
Dec 2017
Completion
Mar 2018
Last update
Aug 20, 2018

Study contacts

Ognjen Gajic, MD
principal investigator · Mayo Clinic
Marija Kojicic, MD
principal investigator · Institute for Pulmonary Diseases, Novi Sad, Serbia
Rahul Kashyap, MD
study director · Mayo Clinic
Marcus Schultz, MD
principal investigator · University of Amsterdam
Michelle N Gong, MD
principal investigator · Montefiore Medical Center, New York USA
Oguz Kilickaya, MD
principal investigator · Gulhane Military Medical Faculty, Ankara, Turkey
Neill Adhikari, MD
principal investigator · University of Toronto, Toronto Canada
Linda Bucher, PhD
principal investigator · College of Health Sciences, University of Delavere, Delawere USA
Daniel Talmor, MD
principal investigator · Beth Israel Deakoness Medical Center, Boston USA
Yue Dong, MD
study director · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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