NCT07233551

Brief Summary

Utilization of CBC-Derived Inflammatory Indices in Assessing Severity and Prognosis of Acute Pancreatitis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

September 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

November 18, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 16, 2025

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Correlation between Prognostic Nutritional Index (PNI) and Clinical Severity of Acute Pancreatitis

    PNI will be calculated as: PNI = 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (/mm³). The correlation between PNI (numeric value) and the clinical severity of acute pancreatitis (based on the Revised Atlanta Classification) will be assessed

    Between 48 and 72 hours after hospital admission

  • Correlation between Systemic Immune-Inflammation Index (SII) and Clinical Severity of Acute Pancreatitis

    SII will be calculated as: SII = (Platelet count × Neutrophil count) / Lymphocyte count. The correlation between SII (numeric value) and clinical severity will be assessed.

    Between 48 and 72 hours after hospital admission

  • Correlation between Systemic Inflammation Response Index (SIRI) and Clinical Severity of Acute Pancreatitis

    SIRI will be calculated as: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count. The correlation between SIRI (numeric value) and clinical severity will be assessed.

    Between 48 and 72 hours after hospital admission

  • Correlation between Platelet-to-Lymphocyte Ratio (PLR) and Clinical Severity of Acute Pancreatitis

    PLR will be calculated as: PLR = Platelet count / Lymphocyte count. The correlation between PLR (numeric ratio) and clinical severity will be assessed.

    Between 48 and 72 hours after hospital admission

  • Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and Clinical Severity of Acute Pancreatitis

    NLR will be calculated as: NLR = Neutrophil count / Lymphocyte count. The correlation between NLR (numeric ratio) and clinical severity will be assessed

    Between 48 and 72 hours after hospital admission

Interventions

Complete blood count, CBC\_based inflammatory indices: 1. Prognostic nutritional index (PNI): PNI is a score based on serum albumin and lymphocyte count, used to assess nutritional and immune status. 2. Systemic inflammation response index (SIRI) : SIRI is an inflammatory marker used to assess systemic inflammation and predict prognosis in various diseases, including cancer and acute conditions. 3. Systemic immune inflammation index (SII) : SII is a composite marker reflecting the balance between host immune and inflammatory status. It is widely used as a prognostic indicator in cancers, cardiovascular disease, and acute inflammatory conditions. 4. platelet lymphcyte ratio (PLR) : (PLR) reflects the balance between thrombosis/inflammation (platelets) and immune regulation (lymphocytes). 5. Neutrophile to lymphcyte ratio (NLR) : (NLR) is a widely used inflammatory marker derived from CBC, indicating systemic inflammation and immune response.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with AP who were treated in our hospital (Al Rhaghe hospital) from January 2019 to March 2025 (age ≥18 years old; written consent will be obtained); also, we prospectively will analyse data of patients with AP who will be admitted within one year

You may qualify if:

  • adult patients aged 18 years old or older.
  • patients with acute pancreatitis who were treated in our hospital from January 2019 to March 2025.

You may not qualify if:

  • history of chronic kidney disease
  • Pregnancy.
  • History of neoplasm
  • present of acute infection
  • history of hematological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wu W, Zhang Y, Zhang Y, Qu X, Zhang Z, Zhang R. Association Between the Systemic Inflammation Response Index and Severity of Acute Pancreatitis: A Retrospective Cohort Study. J Inflamm Res. 2025 Mar 27;18:4471-4480. doi: 10.2147/JIR.S512553. eCollection 2025.

    PMID: 40166595BACKGROUND
  • Alzarea AI, Khan YH, Alanazi AS, Butt MH, Almalki ZS, AlAhmari AK, Alsahali S, Mallhi TH. Barriers and Facilitators of Pharmacoeconomic Studies: A Review of Evidence from the Middle Eastern Countries. Int J Environ Res Public Health. 2022 Jun 27;19(13):7862. doi: 10.3390/ijerph19137862.

    PMID: 35805521BACKGROUND
  • Mirzaei-Alavijeh M, Amini M, Moradinazar M, Eivazi M, Jalilian F. Disparity in cognitive factors related to cancer screening uptake based on the theory of planned behavior. BMC Cancer. 2024 Jul 16;24(1):845. doi: 10.1186/s12885-024-12607-w.

    PMID: 39014335BACKGROUND
  • Krinsley JS, Rule P, Pappy L, Ahmed A, Huley-Rodrigues C, Prevedello D, Preiser JC. The Interaction of Acute and Chronic Glycemia on the Relationship of Hyperglycemia, Hypoglycemia, and Glucose Variability to Mortality in the Critically Ill. Crit Care Med. 2020 Dec;48(12):1744-1751. doi: 10.1097/CCM.0000000000004599.

    PMID: 33031146BACKGROUND
  • Lu Y, Zhang Q, Lou J. Blood glucose-related indicators are associated with in-hospital mortality in critically ill patients with acute pancreatitis. Sci Rep. 2021 Jul 28;11(1):15351. doi: 10.1038/s41598-021-94697-1.

    PMID: 34321549BACKGROUND
  • Kim Y, Choi H, Jung SM, Song JJ, Park YB, Lee SW. Systemic immune-inflammation index could estimate the cross-sectional high activity and the poor outcomes in immunosuppressive drug-naive patients with antineutrophil cytoplasmic antibody-associated vasculitis. Nephrology (Carlton). 2019 Jul;24(7):711-717. doi: 10.1111/nep.13491. Epub 2019 Apr 29.

    PMID: 30203901BACKGROUND
  • Liu G, Tao J, Zhu Z, Wang W. The early prognostic value of inflammatory markers in patients with acute pancreatitis. Clin Res Hepatol Gastroenterol. 2019 Jun;43(3):330-337. doi: 10.1016/j.clinre.2018.11.002. Epub 2018 Dec 10.

    PMID: 30545732BACKGROUND
  • Gorgel SN, Akin Y, Koc EM, Kose O, Ozcan S, Yilmaz Y. Retrospective study of systemic immune-inflammation index in muscle invasive bladder cancer: initial results of single centre. Int Urol Nephrol. 2020 Mar;52(3):469-473. doi: 10.1007/s11255-019-02325-9. Epub 2019 Oct 28.

    PMID: 31659597BACKGROUND
  • Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.

    PMID: 30315778BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Abdelhameed Ahmed Abdelhameed, Master Degree

CONTACT

Mohamed Abozaid Ali, Doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician of internal medicine in Assiut university hospitals

Study Record Dates

First Submitted

September 16, 2025

First Posted

November 18, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

November 18, 2025

Record last verified: 2025-09