The impact of initial scores, white blood cell and platelet counts, and albumin on length of stay and mortality in sepsis patients
| ISRCTN | ISRCTN13543394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13543394 |
- Submission date
- 02/07/2023
- Registration date
- 13/07/2023
- Last edited
- 14/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sepsis is the failure of the immune system to overcome the reaction to infection. Sepsis is a global problem. Simple clinical scores are used in the early detection of sepsis patients, but there are no satisfactory parameters in predicting patient outcomes, especially length of stay and in-hospital mortality. Early detection is a crucial part of its management. This study aims to provide a good parameter to predict the length of stay and in-hospital mortality in sepsis patients. These parameters are expected from clinical scores and laboratory examinations so that they can be used widely.
Who can participate?
Patients aged 18 - 80 years old were admitted from the emergency department to ICU and diagnosed with sepsis
What does the study involve?
This study uses medical record data from sepsis patients who were admitted to the ICU. Vital sign data (respiratory rate, pulse rate, blood pressure, temperature, oxygen saturation) will be extracted to predict patient outcomes (length of stay in the ICU and mortality). The data taker extracts these data from medical records manually. Then these data will be analysed by the investigator.
What are the possible benefits and risks of participating?
The results of this study are expected to provide information to clinicians (general practitioners and related specialists) based on simple clinical and laboratory scores regarding the degree of patient severity and its relationship to patient outcomes. More attention to patients with poor parameter results is expected to reduce the risk of morbidity and mortality in sepsis patients at UPI. The risk from the use of patient data is the leakage of patient information. However, this risk is mitigated by storing research data in special cabinets with certain locks. Access is only allowed by the principal investigator.
Where is the study run from?
Mohammad Soewandhie General Hospital Surabaya (Indonesia)
When is the study starting and how long is it expected to run for?
August 2022 to August 2023
Who is funding the study?
Universitas Ciputra Surabayaa (Indonesia)
Who is the main contact?
Erik Jaya Gunawan, erik.jaya@ciputra.ac.id (Indonesia)
Contact information
Principal Investigator
Anesthesiologist
School of Medicine
Universitas Ciputra Surabaya
Medical Doctor Profession (MDP) Department
CitraLand CBD Boulevard, Made, Kecamatan Sambikerep
Surabaya
60219
Indonesia
 ORCID ID |
0000-0002-7739-4568 |
|---|---|
| Phone | +62 82234573389 |
| erik.jaya@ciputra.ac.id |
Scientific
Anesthesiologist
School of Medicine
Universitas Ciputra Surabaya
Medical Doctor Profession (MDP) Department
CitraLand CBD Boulevard, Made, Kecamatan Sambikerep
Surabaya
60219
Indonesia
| Phone | +62 82234573389 |
|---|---|
| erik.jaya@ciputra.ac.id |
Public
Anesthesiologist
School of Medicine
Universitas Ciputra Surabaya
Medical Doctor Profession (MDP) Department
CitraLand CBD Boulevard, Made, Kecamatan Sambikerep
Surabaya
60219
Indonesia
| Phone | +62 82234573389 |
|---|---|
| erik.jaya@ciputra.ac.id |
Scientific
Department of Medical Doctor Profession
School of Medicine
Universitas Ciputra Surabaya
CitraLand CBD Boulevard, Made, Kecamatan, Sambikerep
Surabaya
60219
Indonesia
| Phone | +62 (031) 7451699 |
|---|---|
| amy.pangestu@ciputra.ac.id |
Public
Department of Medical Doctor Profession
School of Medicine
Universitas Ciputra Surabaya
CitraLand CBD Boulevard, Made, Kecamatan, Sambikerep
Surabaya
60219
Indonesia
| Phone | +62 (031) 7451699 |
|---|---|
| amy.pangestu@ciputra.ac.id |
Study information
| Study design | Single-center observational cohort retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical scores, leucocyte differential counts, platelet counts, and albumin serum levels in emergency department predict the length of stay and in-hospital mortality in sepsis patient in the ICU |
| Study objectives | Higher clinical scores, higher neutrophil, lower lymphocyte, lower platelet, and lower albumin serum levels predict longer length of stay and higher in-hospital mortality in sepsis patients in the ICU |
| Ethics approval(s) |
Approved 15/08/2022, Komite Etik Penelitian Kesehatan RSUD dr. Mohamad Soewandhie (Ethical Comittee in Health Research Mohommad Soewandhie General Hospital) (Jalan Tambak Rejo No. 45-47, Surabaya, 60142, Indonesia; + 62 (031) 3717141; rsud_soewandhie@surabaya.go.id), ref: 013/KE/KEPK/2022 |
| Health condition(s) or problem(s) studied | Sepsis |
| Intervention | This study looks at the impact of initial scores, white blood cell and platelet counts, and albumin on length of stay and mortality in sepsis patients. Sepsis is a global problem. Simple clinical scores are used in the early detection of sepsis patients, but there are no satisfactory parameters in predicting patient outcomes, especially length of stay and in-hospital mortality. These parameters are expected from clinical scores and laboratory examinations so that they can be used widely. This is an observational study using medical record data. Vital sign data in the first 24 hours at the Emergency Department (ED) will be extracted to calculate the clinical score. Laboratory results at ED will be extracted. Length of stay in the ICU (days) will be counted from the first day of care in the ICU. In-hospital mortality was extracted from the death certificate in the medical record. All Data from patients who were admitted to the ICU from September 2021 to August 2022, aged 18-80 years old, diagnosed with sepsis will be extracted. The exclusion criteria include patients who survived in ICU < 24 hours, pregnancy, cancer, autoimmune disease, and COVID-19 disease. The dropout criteria are incomplete and duplicate data. Patient demographic data (sex, age, weight, source of infection, and comorbidities) extraction will be performed from September – November 2022 and analysed using descriptive statistical methods in SPSS Software. Each data collection session obtained 10-15 medical records. Data from independent and dependent variables are subjected to a bivariate test (using a different test according to the type of data). All independent variables which have significant differences are analyzed using multivariate analysis (using a logistic regression test). For significant variables, statistical analysis is continued using the ROC curve to determine the sensitivity and specificity values. Management and recording of data are performed by the healthcare provider in charge. The healthcare provider included General Practitioner on duty and a nurse on duty in ED and ICU. Medical record data is extracted by the data taker. The data taker was a medical student who was trained to fill out the case report form. Extraction of medical record data was undertaken using a manual procedure (from medical record data to hand-written case report form) at the hospital medical record unit at Mohamad Soewandhie General Hospital Surabaya (medical record unit). |
| Intervention type | Other |
| Primary outcome measure | 1. Length of Stay in ICU (days) measured using total days of care in the ICU from medical record data (admitted until discharged from ICU) at the time of data collection 2. In-hospital mortality measured using death certificates in the medical record data at the time of data collection. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 12/08/2022 |
| Completion date | 11/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 150 |
| Key inclusion criteria | 1. Aged 18-80 years old 2. Patient admitted to the Emergency Department 3. Diagnosed with Sepsis |
| Key exclusion criteria | 1. Did not survive > 24 hours after being admitted to ICU 2. Pregnancy or post partum 3. Cancer 4. Autoimmune disease 5. COVID-19 infection |
| Date of first enrolment | 13/09/2022 |
| Date of final enrolment | 04/11/2022 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Surabaya
60142
Indonesia
Sponsor information
University/education
CitraLand CBD Boulevard
Made
Kecamatan Sambikerep
Surabaya
60219
Indonesia
| Phone | +62 031-7451699 |
|---|---|
| info@ciputra.ac.id | |
| Website | https://www.uc.ac.id/en/ |
"ROR" |
https://ror.org/01zj4g759 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 11/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 13/11/2023: Publication in a high-impact national reviewed journal Previous publication and dissemination plan: Planned publication in a Scopus-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Erik Jaya Gunawan, erik.jaya@ciputra.ac.id. These datasets will take the form of raw data in Excel and will be shared by email. Patient data will be identified only by using a participant ID number. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/07/2023 | No | No | ||
| Basic results | 14/11/2023 | No | No |
Additional files
Editorial Notes
14/11/2023: Basic results uploaded.
13/11/2023: The publication and dissemination plan was changed.
14/08/2023: The intention to publish date has been changed from 11/08/2023 to 11/11/2023.
13/07/2023: Trial's existence confirmed by the Health Research Ethics Committee of Dr Mohamad Soewandhie General Hospital (Indonesia)
