Acute Pancreatitis (AP)NCT06828965
Neutrophil-Creatinine Index in Patients with Acute Pancreatitis: Assessment of Severity and Outcome
An observational study of Acute Pancreatitis (AP), run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Pancreatitis (AP)
- What is being tested?
- Neutrophil creatinine index
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Based on previous reported estimated proportion of severe acute pancreatitis that was 15-20% (Silva-Vaz et al., 2020, Heckler et al., 2021) in addition to probability error 5% and 80% power on a two-tailed test, a minimum of 84 patients with acute pancreatitis are needed as an effective sample size for the current issue. To avoid drop out, a total of 120 patients will be recruited. It was calculated by OpenEpi
Who may be able to join
- All patients with AP will be enrolled.
- Both sexes
- Age of patient > 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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 .
Read the 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)
- Being tested
- Neutrophil creatinine index
- Keywords
- acute pancreatitis, severity, accuracy, mortality
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil creatinine indexOther
Neutrophil creatinine index will be calculated
Neutrophil creatinine indexOther
Neutrophi creatinine index will be calculated in all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of neutrophil/creatinine index in prediction severity of acute pancreatitis
A receiver operator characteristics curve will be used to determine the cut-off point of neutrophil/creatinine index in prediction severity of acute pancreatitis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start27 Mar 2025 (estimated)
- Primary completion27 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Mohamed Abdelrahman, Assiut University
- Investigators
- Marwa Ahmed Abdelrahman, Master Degree, Principal investigator, Marwa Ahmed Abdelrahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828965
- Sponsor's protocol ID
- Marwa protocol
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Till finishing the study
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-Creatinine Index in Patients with Acute Pancreatitis: Assessment of Severity and Outcome
- ClinicalTrials.gov ID
- NCT06828965
- Acronym / sponsor ID
- Marwa protocol
- Conditions
- Acute Pancreatitis (AP)
- Keywords
- acute pancreatitis, severity, accuracy, mortality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Mar 2025 (estimated)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Based on previous reported estimated proportion of severe acute pancreatitis that was 15-20% (Silva-Vaz et al., 2020, Heckler et al., 2021) in addition to probability error 5% and 80% power on a two-tailed test, a minimum of 84 patients with acute pancreatitis are needed as an effective sample size for the current issue. To avoid drop out, a total of 120 patients will be recruited. It was calculated by OpenEpi
Key inclusion criteria (3 listed)
- All patients with AP will be enrolled.
- Both sexes
- Age of patient > 18 years old
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Neutrophil creatinine indexNeutrophil creatinine index will be calculated | Other | – |
| Neutrophil creatinine indexNeutrophi creatinine index will be calculated in all patients | Other | – |
Primary outcome
Accuracy of neutrophil/creatinine index in prediction severity of acute pancreatitis
Time frame: One year
A receiver operator characteristics curve will be used to determine the cut-off point of neutrophil/creatinine index in prediction severity of acute pancreatitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No. Till finishing the 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.
Marwa Ahmed Abdelrahman, Master Degree principal investigator
Marwa Ahmed Abdelrahman
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 Acute Pancreatitis (AP), run by Assiut University at 1 site in Egypt.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Feb 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Ahmed Abdelrahman, Master Degree (01201777557 ext. 002, m.hazem75@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of neutrophil/creatinine index in prediction severity of acute pancreatitis (time frame: One year). 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 17 Feb 2025.