Covid19NCT04713852
Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients
An observational study of Covid19, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the SOFA and Apache scores in a COVID-19 ICU cohort and to develop a new prediction model for COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 116 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Mar 2020to 31 Dec 2020
- Phase
- Observational
- 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
Study population: COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.
Who may be able to join
- COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study
The aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the SOFA and Apache scores in a COVID-19 ICU cohort and to develop a new prediction model for COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.
Read the detailed description
The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide. The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61%. The application of scoring systems can facilitate the effective evaluation by physicians to screen severe patients. At present, however, there are no specific scoring systems for the evaluation of COVID-19 patients. Scoring systems such as the Sequential Organ Failure Assessment (SOFA) score can help emergency or critical care physicians for prognosis and predicting mortality. The SOFA score described the condition of multiple organ dysfunction through several parameters, including oxygenation index, mean arterial pressure, Glasgow come scale, creatinine or urine volume, bilirubin, platelets for the respiratory, circulatory, neurological, renal, hepatogenic and coagulation systems respectively. The function of each organ system is scored from 0 to 4, and the individual SOFA scores are summed to a total score. Although SOFA was not initially designed to predict mortality, several studies reveal that SOFA could predict morbidity and mortality in severe ill patients.
Besides the SOFA score, the Acute Physiology and Chronic Health Evaluation (Apache II) scores was designed to measure the severity of disease of patients admitted to the ICU and to predict mortality. The Apache II score is calculated based on physiological measurements such as body temperature, mean arterial pressure, pH, heart and respiratory rate, Glasgow coma scale, oxygenation and blood parameters such as sodium, potassium, creatinine, hematocrit and white blood cell count. Recently, the Apache IV score is developed where additional parameters such as admission information, admission diagnosis and chronic health conditions were take into account.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To predict the mortality based on the SOFA and Apache scores in critically ill ICU patients
Measured: Patients admitted from 13th march 2020 to 17th october 2020
Secondary outcomes (1)
Predictive value
Predictive value of DNR code, gender, BMI, hypertension, Diabetes, age, P/F ratio, anticoagulation and Rockwood Clinical Frailty index
Measured: Patients admitted from 13th march 2020 to 17th october 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start13 Mar 2020
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713852
- Sponsor's protocol ID
- 2020-174
- Status last verified
- Sep 2023
- First submitted
- 15 Jan 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vandenbrande J, Verbrugge L, Bruckers L, Geebelen L, Geerts E, Callebaut I, Gruyters I, Heremans L, Dubois J, Stessel B. Validation of the Acute Physiology and Chronic Health Evaluation (APACHE) II and IV Score in COVID-19 Patients. Crit Care Res Pract. 2021 Jun 19;2021:5443083. doi: 10.1155/2021/5443083. eCollection 2021.
PubMed 34258059
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study
- ClinicalTrials.gov ID
- NCT04713852
- Acronym / sponsor ID
- 2020-174
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jan 2021 (actual)
- 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 aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the SOFA and Apache scores in a COVID-19 ICU cohort and to develop a new prediction model for COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.
Detailed description
The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide. The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61%. The application of scoring systems can facilitate the effective evaluation by physicians to screen severe patients. At present, however, there are no specific scoring systems for the evaluation of COVID-19 patients. Scoring systems such as the Sequential Organ Failure Assessment (SOFA) score can help emergency or critical care physicians for prognosis and predicting mortality. The SOFA score described the condition of multiple organ dysfunction through several parameters, including oxygenation index, mean arterial pressure, Glasgow come scale, creatinine or urine volume, bilirubin, platelets for the respiratory, circulatory, neurological, renal, hepatogenic and coagulation systems respectively. The function of each organ system is scored from 0 to 4, and the individual SOFA scores are summed to a total score. Although SOFA was not initially designed to predict mortality, several studies reveal that SOFA could predict morbidity and mortality in severe ill patients.
Besides the SOFA score, the Acute Physiology and Chronic Health Evaluation (Apache II) scores was designed to measure the severity of disease of patients admitted to the ICU and to predict mortality. The Apache II score is calculated based on physiological measurements such as body temperature, mean arterial pressure, pH, heart and respiratory rate, Glasgow coma scale, oxygenation and blood parameters such as sodium, potassium, creatinine, hematocrit and white blood cell count. Recently, the Apache IV score is developed where additional parameters such as admission information, admission diagnosis and chronic health conditions were take into account.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.
Key inclusion criteria (1 listed)
- COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Patients admitted from 13th march 2020 to 17th october 2020
To predict the mortality based on the SOFA and Apache scores in critically ill ICU patients
1 secondary outcome
Predictive value
Time frame: Patients admitted from 13th march 2020 to 17th october 2020
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 28 Sep 2023.
- Derived from this study: PubMed 34258059Vandenbrande J, Verbrugge L, Bruckers L, Geebelen L, Geerts E, Callebaut I, Gruyters I, Heremans L, Dubois J, Stessel B. Validation of the Acute Physiology and Chronic Health Evaluation (APACHE) II and IV Score in COVID-19 Patients. Crit Care Res Pract. 2021 Jun 19;2021:5443083. doi: 10.1155/2021/5443083. eCollection 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Jessa Hospital at 1 site in Belgium.
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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Mortality (time frame: Patients admitted from 13th march 2020 to 17th october 2020). 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 NCT04713852, which also lists 1 linked publication.
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 28 Sep 2023.