Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05955547 |
| Other study ID # |
APACHE-INf |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Bursa City Hospital |
| Contact |
Nizameddin Koca, MD |
| Phone |
05052324063 |
| Email |
nkoca[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
