Intensive Care UnitNCT05955547
The New ICU Prognostic Score APACHE-INf
An observational study of Intensive Care Unit and Inflammation, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Intensive care units (ICUs) aim to provide specialized care for patients with high morbidity and mortality risks. To effectively identify patients requiring urgent diagnosis and treatment, various scoring systems have been developed, including APACHE-II. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Inflammation, Nutritional Deficiency
- What is being tested?
- Prognosis Scoring
- How many people
- 15,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were admitted to ICU between 2019 and 2023
Who may be able to join
- ICU admission
- Age over 18
Who cannot join
- Incomplete data
- Age under 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Bursa Sehir Training & Research Hospital
Nilufer, Bursa, 16110
Nizameddin Koca, MD, 05052324063, nkoca@yahoo.com
Nizameddin Koca, MD
About this study
Official title: Comparison of the New Score (APACHE-INf), Including Inflammatory and Nutritional Parameters, With APACHE-II in the Prognosis of Patients Admitted to ICU
Intensive care units (ICUs) aim to provide specialized care for patients with high morbidity and mortality risks. To effectively identify patients requiring urgent diagnosis and treatment, various scoring systems have been developed, including APACHE-II. However, these systems primarily focus on evaluating organ dysfunction and do not consider the patient's nutritional status or the role of inflammation. Recent studies have highlighted the crucial role of inflammation in patient outcomes, emphasizing the need to incorporate inflammatory parameters into scoring systems for accurate prognosis prediction. Additionally, nutritional status upon ICU admission has been largely overlooked in current scoring systems, despite its significant impact on patient outcomes. Malnourished patients have higher risks of complications, prolonged hospital stays, and increased mortality rates. Adequate nutrition supports immune function, tissue repair, and the response to therapeutic interventions, ultimately minimizing complications. Integrating nutritional assessment into existing scoring systems allows for early identification of malnourished patients and timely interventions, improving overall care quality in the ICU. Considering the importance of inflammation and nutritional status, this study aims to develop a new scoring system by adding inflammatory and nutritional parameters to APACHE II score. This comprehensive approach holds promise for enhancing patient outcomes, accurately evaluating clinical severity, and facilitating immediate interventions in critical care settings.
Read the detailed description
Intensive care units are units where patients with high morbidity and mortality risk are followed up and treated. Risk stratification of patients in intensive care admission is very important in terms of quickly identifying patients who will require urgent diagnosis and treatment. For this reason, many scoring systems have been developed in recent years, and although the most common APACHE-II score is routinely applied in our intensive care units, there is no universally accepted consensus yet. Existing scoring systems predict prognosis mostly by evaluating organ dysfunction. The importance of inflammation and inflammatory response in organ functions has been better understood, especially in the COVID process. Nutritional status upon admission has not been evaluated in the current scoring systems.
Inflammation plays an important role in both regeneration and the fight against microorganisms at the cellular and tissue level. Recent studies have clearly demonstrated the importance of inflammation and inflammatory response in the morbidity and mortality of patients. In this context, there are studies reporting that some prominent inflammatory parameters are associated with morbidity and mortality rates in intensive care patients.
Based on the available evidence, it is evaluated that a scoring system that does not include inflammatory parameters cannot provide an accurate prognosis prediction.
the evaluation of nutritional status upon ICU admission is a vital component of patient care that has been largely overlooked in current scoring systems.
Malnourished patients are at a higher risk of developing complications, prolonged hospital stays, and increased mortality rates compared to well-nourished patients. Adequate nutrition not only supports immune function and tissue repair but also impacts the patient's response to therapeutic interventions and the prevention of complications during their ICU stay. Recognizing the significance of adequate nutrition in critical illness is essential to optimize patient outcomes and minimize complications. By integrating nutritional assessment into existing scoring systems, healthcare providers can identify malnourished patients early, implement timely interventions, and improve the overall quality of care in the ICU. This comprehensive approach holds promise for enhancing patient outcomes, reducing morbidity and mortality rates, and optimizing resource utilization in critical care settings.
Incorporating inflammation and nutritional status evaluation into existing scoring systems can provide a more comprehensive assessment of a patient's overall condition. Therefore, in this study, we aimed to evaluate whether a new scoring system, which will be created by adding inflammatory and nutritional parameters to APACHE II and SOFA scores, will provide a more accurate prognosis prediction.The electronic files of the patients who were followed up in Bursa City Hospital Intensive Care Units between 01.01.2020-31.12.2022 will be scanned retrospectively. Demographic data, clinical and laboratory data detailed below will be recorded in the files. After determining the cut-off points and scoring scale for each of the inflammatory tests at the time of admission obtained from the patient files, the competencies of the new and old scores obtained in prognosis prediction will be compared. By determining the cut-off points for the new scoring, it will be possible to evaluate the clinical severity of the patients more accurately and to carry out the necessary procedures immediately.
Data to be scanned from files:
Demographic data of the patient: Age, height, weight, Glasgow Coma score, APACHE 2 score, SOFA score, Concomitant diseases, Respiratory rate, Fever, Heart rate, SBP, DBP, OABP, Blood gas data: pH, pO2, PCO2, Osmolarity, Lactate, HCO3 Laboratory data: Detailed Hemogram data (WBC, Hgb, Hct, MCV, MPV, RDW, Plt, neutrophil, lymphocyte), Glucose, BUN, Cre, AST, ALT, T.bil, D.bil, Na, K, Ca, Mg, T. Protein, Albumin, Prealbumin, INR, aPTT, Vitamin D, Total cholesterol, LDL, HDL and Triglyseride Inflammation Parameters: Sedimentation, CRP, ferritin, D-dimer, fibrinogen, IL-6, procalcitonin
- Conditions
- Intensive Care Unit, Inflammation, Nutritional Deficiency
- Being tested
- Prognosis Scoring
- Keywords
- APACHE-INf, Prognosis scoring, Intensive Care Unit, inflammation, nutrition
- Medical subject headings
- Inflammation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognosis ScoringOther
To determine the prognosis of patients admitted to ICU with a scoring system that includes inflammation and nutritional status
| Study group | Role | What they receive |
|---|---|---|
| APACHE-II | Not described Receives: Other: Prognosis Scoring | |
| APACHE-Inf | Not described Receives: Other: Prognosis Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Prediction
Development with a score system that includes inflammation and nutritional status data in addition to APACHE-II scores would give a chance to evaluate ICU patient's overall status and predict the mortality risk more accurately
Measured: data of the ICU patients from 2019 to 2023 were evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Nermin Kelebek Girgin, Ayşegül Özkan, Gülbahar Çalışkan
- Responsible party
- Principal investigator, Nizameddin Koca, MD, Bursa City Hospital
- Investigators
- Nizameddin Koca, MD, Principal investigator, University of Health Sciences, Bursa Sehir Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955547
- Sponsor's protocol ID
- APACHE-INf
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study would be performed as a multicenter study after single center data evaluation. IPD data would be shared with the participants of multicenter design researchers after the completion of single center study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the New Score (APACHE-INf), Including Inflammatory and Nutritional Parameters, With APACHE-II in the Prognosis of Patients Admitted to ICU
- ClinicalTrials.gov ID
- NCT05955547
- Acronym / sponsor ID
- APACHE-INf
- Conditions
- Intensive Care Unit, Inflammation, Nutritional Deficiency
- Keywords
- APACHE-INf, Prognosis scoring, Intensive Care Unit, inflammation, nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Nermin Kelebek Girgin, Ayşegül Özkan, Gülbahar Çalışkan
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Jul 2023 (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.
Intensive care units (ICUs) aim to provide specialized care for patients with high morbidity and mortality risks. To effectively identify patients requiring urgent diagnosis and treatment, various scoring systems have been developed, including APACHE-II. However, these systems primarily focus on evaluating organ dysfunction and do not consider the patient's nutritional status or the role of inflammation. Recent studies have highlighted the crucial role of inflammation in patient outcomes, emphasizing the need to incorporate inflammatory parameters into scoring systems for accurate prognosis prediction. Additionally, nutritional status upon ICU admission has been largely overlooked in current scoring systems, despite its significant impact on patient outcomes. Malnourished patients have higher risks of complications, prolonged hospital stays, and increased mortality rates. Adequate nutrition supports immune function, tissue repair, and the response to therapeutic interventions, ultimately minimizing complications. Integrating nutritional assessment into existing scoring systems allows for early identification of malnourished patients and timely interventions, improving overall care quality in the ICU. Considering the importance of inflammation and nutritional status, this study aims to develop a new scoring system by adding inflammatory and nutritional parameters to APACHE II score. This comprehensive approach holds promise for enhancing patient outcomes, accurately evaluating clinical severity, and facilitating immediate interventions in critical care settings.
Detailed description
Intensive care units are units where patients with high morbidity and mortality risk are followed up and treated. Risk stratification of patients in intensive care admission is very important in terms of quickly identifying patients who will require urgent diagnosis and treatment. For this reason, many scoring systems have been developed in recent years, and although the most common APACHE-II score is routinely applied in our intensive care units, there is no universally accepted consensus yet. Existing scoring systems predict prognosis mostly by evaluating organ dysfunction. The importance of inflammation and inflammatory response in organ functions has been better understood, especially in the COVID process. Nutritional status upon admission has not been evaluated in the current scoring systems.
Inflammation plays an important role in both regeneration and the fight against microorganisms at the cellular and tissue level. Recent studies have clearly demonstrated the importance of inflammation and inflammatory response in the morbidity and mortality of patients. In this context, there are studies reporting that some prominent inflammatory parameters are associated with morbidity and mortality rates in intensive care patients.
Based on the available evidence, it is evaluated that a scoring system that does not include inflammatory parameters cannot provide an accurate prognosis prediction.
the evaluation of nutritional status upon ICU admission is a vital component of patient care that has been largely overlooked in current scoring systems.
Malnourished patients are at a higher risk of developing complications, prolonged hospital stays, and increased mortality rates compared to well-nourished patients. Adequate nutrition not only supports immune function and tissue repair but also impacts the patient's response to therapeutic interventions and the prevention of complications during their ICU stay. Recognizing the significance of adequate nutrition in critical illness is essential to optimize patient outcomes and minimize complications. By integrating nutritional assessment into existing scoring systems, healthcare providers can identify malnourished patients early, implement timely interventions, and improve the overall quality of care in the ICU. This comprehensive approach holds promise for enhancing patient outcomes, reducing morbidity and mortality rates, and optimizing resource utilization in critical care settings.
Incorporating inflammation and nutritional status evaluation into existing scoring systems can provide a more comprehensive assessment of a patient's overall condition. Therefore, in this study, we aimed to evaluate whether a new scoring system, which will be created by adding inflammatory and nutritional parameters to APACHE II and SOFA scores, will provide a more accurate prognosis prediction.The electronic files of the patients who were followed up in Bursa City Hospital Intensive Care Units between 01.01.2020-31.12.2022 will be scanned retrospectively. Demographic data, clinical and laboratory data detailed below will be recorded in the files. After determining the cut-off points and scoring scale for each of the inflammatory tests at the time of admission obtained from the patient files, the competencies of the new and old scores obtained in prognosis prediction will be compared. By determining the cut-off points for the new scoring, it will be possible to evaluate the clinical severity of the patients more accurately and to carry out the necessary procedures immediately.
Data to be scanned from files:
Demographic data of the patient: Age, height, weight, Glasgow Coma score, APACHE 2 score, SOFA score, Concomitant diseases, Respiratory rate, Fever, Heart rate, SBP, DBP, OABP, Blood gas data: pH, pO2, PCO2, Osmolarity, Lactate, HCO3 Laboratory data: Detailed Hemogram data (WBC, Hgb, Hct, MCV, MPV, RDW, Plt, neutrophil, lymphocyte), Glucose, BUN, Cre, AST, ALT, T.bil, D.bil, Na, K, Ca, Mg, T. Protein, Albumin, Prealbumin, INR, aPTT, Vitamin D, Total cholesterol, LDL, HDL and Triglyseride Inflammation Parameters: Sedimentation, CRP, ferritin, D-dimer, fibrinogen, IL-6, procalcitonin
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APACHE-II | – | Other: Prognosis Scoring |
| APACHE-Inf | – | Other: Prognosis Scoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were admitted to ICU between 2019 and 2023
Key inclusion criteria (2 listed)
- ICU admission
- Age over 18
Key exclusion criteria (2 listed)
- Incomplete data
- Age under 18
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 |
|---|---|---|
| Prognosis ScoringTo determine the prognosis of patients admitted to ICU with a scoring system that includes inflammation and nutritional status | Other | APACHE-II, APACHE-Inf |
Primary outcome
Mortality Prediction
Time frame: data of the ICU patients from 2019 to 2023 were evaluated
Development with a score system that includes inflammation and nutritional status data in addition to APACHE-II scores would give a chance to evaluate ICU patient's overall status and predict the mortality risk more accurately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Undecided. The study would be performed as a multicenter study after single center data evaluation. IPD data would be shared with the participants of multicenter design researchers after the completion of single center study.
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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.
Nizameddin Koca, MD principal investigator
University of Health Sciences, Bursa Sehir Training & Research Hospital
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 Intensive Care Unit and Inflammation, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 21 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nizameddin Koca, MD (05052324063, nkoca@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Prediction (time frame: data of the ICU patients from 2019 to 2023 were evaluated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.