Neutrophil-Creatinine Index in Patients with Acute Pancreatitis: Assessment of Severity and Outcome

NCT ID: NCT06828965

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2026-12-31

Brief Summary

Acute pancreatitis is a disease that usually has a mild disease course. However, around 20-30% of the patients develop severe complications. Persistent organ failure, with or without the presence of local complications such as (peri-) pancreatic necrosis and secondary infections, is the main determinant for mortality, and these patients are classified as having severe acute pancreatitis according to the revised Atlanta classification . The most widely used classification systems for determining the severity and course of AP are the revised Atlanta classification and the Bedside Index of Severity in Acute Pancreatitis (BISAP). According to the revised Atlanta classification, the severity of AP is graded as mild acute pancreatitis (MAP), moderately severe acute pancreatitis (MSAP), or severe acute pancreatitis (SAP) . In addition to the revised Atlanta classification and BISAP, several other prognostic scoring systems and classifications have been developed to predict the severity of AP. Ranson's criteria, the Acute Physiology and Chronic Health Evaluation (APACHE) II score, the Modified Glasgow Prognostic Score, and the Balthazar index are other commonly used prognostic systems . Most of these scoring systems include multiple determinants or parameters that must be noted 24 to 48 h after hospitalization, and the estimation of the severity of AP is delayed until 48 h after hospitalization. Thus, these scoring systems are of limited use at admission. On the other hand, in view of the complexity of prognostic scoring systems, several studies have been conducted on the role of simple laboratory parameters and indices in predicting the disease severity of AP and mortality . The most widely studied laboratory parameters and indices are the white blood cell count (WBC), neutrophil count, neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), C-reactive protein (CRP), and procalcitonin. These laboratory parameters have also been used as part of several prognostic scoring systems. Nevertheless, none of the laboratory parameters or prognostic scoring systems can predict the severity of AP or MOF with sufficient accuracy . Moreover, it is not easy to predict the course and severity of acute pancreatitis at the first assessment of hospital admission. At the time of admission, most laboratory parameters are insufficient to differentiate mild disease from severe disease, and changes in laboratory parameters over time, including inflammatory markers and parameters related to organ/system dysfunction, provide important clues regarding the course of the disease . On the other hand, there is a need for simple, reliable, widely used parameters at admission for predicting the course of the disease. Sahin (2024) found a new index named the neutrophil-creatinine index (NCI), which was established based on the levels of neutrophil count and creatinine, to predict the severity of AP at admission . It's known that neutrophil infiltration and activation is one of the early events in acute pancreatitis and results in higher neutrophil count values at admission. Similarly, higher creatinine values at admission indicate renal hypoperfusion, which is associated with third-space leakage resulting from a systemic inflammatory state. It was assumed that the NCI may serve as an efficient test to represent the combination of inflammatory response and organ dysfunction .

Detailed Description

Inclusion criteria

• All patients with AP will be enrolled.
• Both sexes
• Age of patient > 18 years old Exclusion criteria Any patient with one or more of the following criteria is excluded;
• Age less than 18 years old
• Pancreatic cancer
• Picture of chronic pancreatitis
• Recurrent pancreatitis

Conditions

Acute Pancreatitis (AP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Neutrophil creatinine index

Neutrophil creatinine index will be calculated

Intervention Type: OTHER

Neutrophil creatinine index

Neutrophi creatinine index will be calculated in all patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients with AP will be enrolled.
• Both sexes
• Age of patient > 18 years old

Exclusion Criteria

• Age less than 18 years old
• Pancreatic cancer
• Picture of chronic pancreatitis
• Recurrent pancreatitis
• pregnancy, end-stage renal disease, hematological disorders, pancreatic carcinoma or cholangiocarcinoma, and incomplete records.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Ahmed Mohamed Abdelrahman

Principal Investigator Marwa Ahmed Mohamed Abdelrahman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Ahmed Abdelrahman, Master Degree

Role: PRINCIPAL_INVESTIGATOR

Marwa Ahmed Abdelrahman

Locations

Assiut University Egypt

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Marwa Ahmed Abdelrahman, Master Degree

Role: CONTACT

m.hazem75@icloud.com

01201777557 ext. 002

Mohammad Alyamany Kobeisy, PHD

Role: CONTACT

yamany1@med.aun.edu.eg

01005509890 ext. 002

Other Identifiers

Marwa protocol

Identifier Type: -

Identifier Source: org_study_id