ICU Scoring System in Covid 19NCT05308524
Scoring Systems covid19
An observational study of ICU Scoring System in Covid 19, run by Assiut University.
Trial summary
In this study, we planned to investigate the role and determine the predictive performance of both APACHE II and SAPS II scoring systems and compare them in COVID-19 patients admitted to the intensive care unit of Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ICU Scoring System in Covid 19
- What is being tested?
- ICU scoring system in covid 19
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to Dec 2023
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Sample size was calculated using Epi- Info7. Based on previous studies the mortality rate of Covid-19 ICU admitted patients varies between countries, in low resources sittings the mortality rate was around 50% *[7 ]*. With a confidence limits of 10% and a confidence level of 90% the minimum number of patients required for this study is 70 patients
Who may be able to join
- • This study will be conducted on laboratory-confirmed COVID-19 patients who will be transferred to the intensive care unit of Assiut University Hospital
Who cannot join
- Patients would be excluded from this study if they died or were discharged from the intensive care unit prior collection of data required for both the APACHE II and SAPS II scoring systems, if they were discharged before their outcomes were determined and if we could not obtain consent from them or their companions to participate in this study. All patients involved will be subjected to a full history with special stress on age, gender, special habits, and associated diseases. Information such as the patient's need for ventilatory support as well as the length of ICU stay will be entered. Also, the laboratory results and Imaging findings will be registered. Scores of APACHE II and SAPS II were calculated as illustrated in the previously published works *[5,6]* .Patients will be followed up until their outcome was determined.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Disease Severity Scoring Systems in Predicting Mortality covid19 Pts in AUH
In this study, we planned to investigate the role and determine the predictive performance of both APACHE II and SAPS II scoring systems and compare them in COVID-19 patients admitted to the intensive care unit of Assiut University Hospital.
Read the detailed description
Since the start of the coronavirus disease 2019 (COVID-19) pandemic, intensive care units (ICUs) worldwide have struggled to treat affected patients who require a completely different approach to treatment than other patients
- [1]* .This study aims to evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anaesthesia alone.Although many severe cases are admitted to ICUs, it is unknown whether the conventional disease-severity scoring systems that were developed for ICU patients can be applied to patients with COVID-19.Several recent studies have used Acute Physiology and Chronic Health Evaluation (APACHE) and Simplified Acute Physiology Score (SAPS) to provide information on the clinical severity of COVID-19
- [2-4]*. However, very few reports have examined their validity of applying them to patients with COVID-19.
- Conditions
- ICU Scoring System in Covid 19
- Being tested
- ICU scoring system in covid 19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU scoring system in covid 19Diagnostic test
The intensive care unit (ICU) at Assiut University Hospital, which is supervised by the staff members of the Chest Diseases Department and designated to deal with critically ill Covid 19 patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU scoring system in covid 19
SAPS ,APACHE ICU scoring system in covid 19
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
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 ICU Scoring System in Covid 19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Mohamed Thabet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308524
- Sponsor's protocol ID
- ICU scoring system in covid19
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
PubMed 32087114Michard F, Vieillard-Baron A. Critically ill patients with COVID-19: are they hemodynamically unstable and do we know why? Intensive Care Med. 2021 Feb;47(2):254-255. doi: 10.1007/s00134-020-06238-5. Epub 2020 Sep 10. No abstract available.
PubMed 32910203
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Disease Severity Scoring Systems in Predicting Mortality covid19 Pts in AUH
- ClinicalTrials.gov ID
- NCT05308524
- Acronym / sponsor ID
- ICU scoring system in covid19
- Conditions
- ICU Scoring System in Covid 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Apr 2022 (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.
In this study, we planned to investigate the role and determine the predictive performance of both APACHE II and SAPS II scoring systems and compare them in COVID-19 patients admitted to the intensive care unit of Assiut University Hospital.
Detailed description
Since the start of the coronavirus disease 2019 (COVID-19) pandemic, intensive care units (ICUs) worldwide have struggled to treat affected patients who require a completely different approach to treatment than other patients
- [1]* .This study aims to evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anaesthesia alone.Although many severe cases are admitted to ICUs, it is unknown whether the conventional disease-severity scoring systems that were developed for ICU patients can be applied to patients with COVID-19.Several recent studies have used Acute Physiology and Chronic Health Evaluation (APACHE) and Simplified Acute Physiology Score (SAPS) to provide information on the clinical severity of COVID-19
- [2-4]*. However, very few reports have examined their validity of applying them to patients with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sample size was calculated using Epi- Info7. Based on previous studies the mortality rate of Covid-19 ICU admitted patients varies between countries, in low resources sittings the mortality rate was around 50% *[7 ]*. With a confidence limits of 10% and a confidence level of 90% the minimum number of patients required for this study is 70 patients
Key inclusion criteria (1 listed)
- • This study will be conducted on laboratory-confirmed COVID-19 patients who will be transferred to the intensive care unit of Assiut University Hospital
Key exclusion criteria (1 listed)
- Patients would be excluded from this study if they died or were discharged from the intensive care unit prior collection of data required for both the APACHE II and SAPS II scoring systems, if they were discharged before their outcomes were determined and if we could not obtain consent from them or their companions to participate in this study. All patients involved will be subjected to a full history with special stress on age, gender, special habits, and associated diseases. Information such as the patient's need for ventilatory support as well as the length of ICU stay will be entered. Also, the laboratory results and Imaging findings will be registered. Scores of APACHE II and SAPS II were calculated as illustrated in the previously published works *[5,6]* .Patients will be followed up until their outcome was determined.
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 |
|---|---|---|
| ICU scoring system in covid 19The intensive care unit (ICU) at Assiut University Hospital, which is supervised by the staff members of the Chest Diseases Department and designated to deal with critically ill Covid 19 patients. | Diagnostic test | – |
Primary outcome
ICU scoring system in covid 19
Time frame: Baseline
SAPS ,APACHE ICU scoring system in covid 19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 32087114Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32910203Michard F, Vieillard-Baron A. Critically ill patients with COVID-19: are they hemodynamically unstable and do we know why? Intensive Care Med. 2021 Feb;47(2):254-255. doi: 10.1007/s00134-020-06238-5. Epub 2020 Sep 10. No abstract available.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Scoring System in Covid 19, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtesam Mohamed thabet, 1 (01020135853, ebtesamm582@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU scoring system in covid 19 (time frame: Baseline). 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 NCT05308524, 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 4 Apr 2022.