NCT06240338

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

January 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

January 2, 2024

Last Update Submit

February 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    within 18 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of tropical medicine

Study Record Dates

First Submitted

January 2, 2024

First Posted

February 5, 2024

Study Start

February 20, 2024

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02