Acute PancreatitisNCT06240338
Acute Pancreatitis : Comparison of Various Scores in Predicting Severity and Outcome
An observational study of Acute Pancreatitis, run by Sohag University.
Trial summary
The study will make a comparison between Various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- laboratory investigation and Imaging
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * age <18 years old, * patients with metastatic tumor * late stage of liver cirrhosis * active tuberculosis * refractory heart failure * previous transplantation * immunosuppressive therapy * pregnancy * patients with chronic pancreatitis or pancreas carcinoma
Who may be able to join
- Any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study.
Who cannot join
- -
About this study
The study will make a comparison between Various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis
Read the detailed description
the study will evaluate the relationship between homeostatic model assessment of insulin resistance , bedside index of severity score and the harmless acute pancreatitis score and prognosis of acute pancreatitis ,will compare of these scores in predicting severity of acute pancreatitis and will compare of these scores in predicting outcome of acute pancreatitis.
- Conditions
- Acute Pancreatitis
- Being tested
- laboratory investigation and Imaging
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory investigation and ImagingDiagnostic test
laboratory parameters (white blood cell count,neutrophil count, lymphocyte count, hemoglobin level, platelet level, red cell distribution width (RDW) level, hematocrit (HCT), renal function, hepatic function, electrolytes, arterial blood gas, HOMA-IR) will be assessed and imaging: Abdominal ultrasonography, Abdominal CT or MRI if needed
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of various scores in predicting severity and outcome in patients with acute pancreatitis. 1.Homeostatic model assessment of insulin resistance. 2.The harmless acute pancreatitis score.
- Homeostatic model assessment of insulin resistance it measure severity of insulin resistance, there is an association between insulin resistance and severity of acute pancreatitis. It is defined as fasting glucose (mmol/L) × fasting insulin (μmol/L)/22.5] or [fasting glucose (mg/dL) × fasting insulin (μmol/L) Reference index levels is ≤ 2. If index ˃ 2 indicate presence of insulin resistance
- The harmless acute pancreatitis score Harmless acute pancreatitis score contains three parameters - blood urea nitrogen, levels of serum creatinine and haematocrit . The patient is classified as harmless acute pancreatitis score negative (-) if they have blood urea nitrogen <25 mg/dL, serum creatinine levels < 2 mg/dL, and haematocrit levels of <43% for males and <39.6% for females at the time of admission. The patient is considered positive (+) if any one of the above parameters is positive.
Measured: within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Bakr Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240338
- Sponsor's protocol ID
- Soh-Med-23-12-05MD
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pancreatitis : Comparison of Various Scores in Predicting Severity and Outcome
- ClinicalTrials.gov ID
- NCT06240338
- Acronym / sponsor ID
- Soh-Med-23-12-05MD
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 5 Feb 2024 (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.
The study will make a comparison between Various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis
Detailed description
the study will evaluate the relationship between homeostatic model assessment of insulin resistance , bedside index of severity score and the harmless acute pancreatitis score and prognosis of acute pancreatitis ,will compare of these scores in predicting severity of acute pancreatitis and will compare of these scores in predicting outcome of acute pancreatitis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * age <18 years old, * patients with metastatic tumor * late stage of liver cirrhosis * active tuberculosis * refractory heart failure * previous transplantation * immunosuppressive therapy * pregnancy * patients with chronic pancreatitis or pancreas carcinoma
Key inclusion criteria (1 listed)
- Any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| laboratory investigation and Imaginglaboratory parameters (white blood cell count,neutrophil count, lymphocyte count, hemoglobin level, platelet level, red cell distribution width (RDW) level, hematocrit (HCT), renal function, hepatic function, electrolytes, arterial blood gas, HOMA-IR) will be assessed and imaging: Abdominal ultrasonography, Abdominal CT or MRI if needed | Diagnostic test | – |
Primary outcome
Comparison of various scores in predicting severity and outcome in patients with acute pancreatitis. 1.Homeostatic model assessment of insulin resistance. 2.The harmless acute pancreatitis score.
Time frame: within 18 months
1. Homeostatic model assessment of insulin resistance it measure severity of insulin resistance, there is an association between insulin resistance and severity of acute pancreatitis. It is defined as fasting glucose (mmol/L) × fasting insulin (μmol/L)/22.5] or [fasting glucose (mg/dL) × fasting insulin (μmol/L) Reference index levels is ≤ 2. If index ˃ 2 indicate presence of insulin resistance 2. The harmless acute pancreatitis score Harmless acute pancreatitis score contains three parameters - blood urea nitrogen, levels of serum creatinine and haematocrit . The patient is classified as harmless acute pancreatitis score negative (-) if they have blood urea nitrogen <25 mg/dL, serum creatinine levels < 2 mg/dL, and haematocrit levels of <43% for males and <39.6% for females at the time of admission. The patient is considered positive (+) if any one of the above parameters is positive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Sohag University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of various scores in predicting severity and outcome in patients with acute pancreatitis. 1.Homeostatic model assessment of insulin resistance. 2.The harmless acute pancreatitis score. (time frame: within 18 months). 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 14 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.