Critical IllnessNCT01973829
The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
A study testing Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN) in people with Critical Illness and Sepsis, run by Mayo Clinic at 30 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Respiratory Failure
- What is being tested?
- Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,215 participants
- Where
- 30 sitesin 17 countries
- Study dates
- Nov 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (≥ 18 years) patients admitted for the first time to the participating ICUs will be included.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 17 countries.
30 sites in 17 countries
China7 sites
Beijing Hospital
Beijing
Guang An Men Hospital
Beijing
China West China Hospital
Chengdu
1st Affiliated Hospital of Guangzhou Medical University
Guangzhusi
Anhui Province Hospital
Hefei
China Shanghai Changhai Hospital
Shanghai
Tianjin First Center Hospital
Tianjin
Bosnia and Herzegovina3 sites
University Hospital Banja Luka
Banja Luka
Sveučilišna klinička bolnica
Mostar
Prim.Dr. Abdulah Nakaš
Sarajevo
India3 sites
Kasturba Hospital
Manial, Karnataka
Lok Nayak Hospital
New Delhi, National Capital Territory of Delhi
Ispat General Hospital
Raurkela, Odisha
Philippines2 sites
St. Luke's Medical Center
Manila
The Med City Hospital
Manila
Serbia2 sites
Military Medical Academy
Belgrade
The Institute for pulmonary diseases of Vojvodina
Kamenitz
Turkey (Türkiye)2 sites
Akdeniz University Hospital
Antalya
Gulhane Military Medical Faculty
Antalya
Dominican Republic1 site
Centro De Diagnostica Imagenes Medicina Avanzada y Telemedicina CEDIMAT
Santo Domingo
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
Mexico City
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital and Research Center
Lahore
Poland1 site
Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznań
Poznan
About this study
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
- Being tested
- Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
- Keywords
- CERTAIN, Checklist, ICU, Outcome, Adults
- Medical subject headings
- Critical Illness, Sepsis, Respiratory Insufficiency, Shock, Coma, Hemorrhage, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)Other
Also called Checklist
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
| Study group | Role | What they receive |
|---|---|---|
| Baseline arm | Other | baseline data (50 patients or 3 months per center) Receives: Other: Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: Participants will be followed for the duration of 4 weeks and hospital discharge (up to 10 weeks post discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Ognjen Gajic, MD, Principal investigator, Mayo ClinicMarija Kojicic, MD, Principal investigator, Institute for Pulmonary Diseases, Novi Sad, SerbiaRahul Kashyap, MD, Study director, Mayo ClinicMarcus Schultz, MD, Principal investigator, University of AmsterdamMichelle N Gong, MD, Principal investigator, Montefiore Medical Center, New York USAOguz Kilickaya, MD, Principal investigator, Gulhane Military Medical Faculty, Ankara, TurkeyNeill Adhikari, MD, Principal investigator, University of Toronto, Toronto CanadaLinda Bucher, PhD, Principal investigator, College of Health Sciences, University of Delavere, Delawere USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973829
- Sponsor's protocol ID
- 12-007998
- Status last verified
- Aug 2018
- First submitted
- 23 Oct 2013
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2026 Jul;41(7):660-669. doi: 10.1177/08850666251396016. Epub 2025 Nov 24.
PubMed 41284657Vukoja 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)
- ClinicalTrials.gov ID
- NCT01973829
- Acronym / sponsor ID
- 12-007998
- Conditions
- Critical Illness, Sepsis, Respiratory Failure, Shock, Coma, Bleeding
- Keywords
- CERTAIN, Checklist, ICU, Outcome, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,215 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline arm | Other | Other: Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)baseline data (50 patients or 3 months per center) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (≥ 18 years) patients admitted for the first time to the participating ICUs will be included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)Also: ChecklistThis 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 | Baseline arm |
Primary outcome
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
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Derived from this study: PubMed 41284657Tekin 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. 2026 Jul;41(7):660-669. doi: 10.1177/08850666251396016. Epub 2025 Nov 24.
- Derived from this study: PubMed 33729718Vukoja 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.
- education and introduction websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
30 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN) in people with Critical Illness and Sepsis, run by Mayo Clinic at 30 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China, Bosnia and Herzegovina, India, Philippines, Serbia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to best critical care practices (time frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.