- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03740685
Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis
November 9, 2018 updated by: Mahmoud Abdelhamed, Assiut University
changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assuit, Egypt, 171516
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with acute pancreatitis
Description
Inclusion Criteria:
- Age>=18 years
Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
- Typical epigastric abdominal pain
- Elevation amylase/lipase >3 times upper limit normal and/or
- Confirmatory findings on cross-sectional imaging
- Enrollment within 8 hours of presentation
Exclusion Criteria:
- Class II or greater NYHA heart failure
- Oxygen dependent COPD
- Chronic kidney disease>stage 2
- Existing necrosis on abdominal CT
- Organ dysfunction prior to enrollment
- Sepsis
- Acute respiratory distress syndrome
- Malignancy not in remission for at least 5 years
- Active drug use
- Known allergy to dexamethasone
- Altered mental status
- Insulin-requiring diabetes
- Abdominal surgery within 60days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with acute pancreatitis
All patients will recive different lines of treatment {saline,antibiotics,dexamethasone}
|
High sesitive C reactive protien will be evaluated at admission time and after 36 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High sesitive C reactive protien
Time Frame: 72hours
|
Level of High sesitive C reactive protien expected to be changed with different lines of treatment and will be compaered
|
72hours
|
|
Serum Amylase
Time Frame: 72hours
|
Level of Serum Amylase expected to be changed with different lines of treatment and will be compaered
|
72hours
|
|
Serum Lipase
Time Frame: 72hours
|
Level of Serum Lipase expected to be changed with different lines of treatment and will be compaered
|
72hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 9, 2018
Primary Completion (Anticipated)
November 9, 2018
Study Completion (Anticipated)
October 8, 2019
Study Registration Dates
First Submitted
October 11, 2018
First Submitted That Met QC Criteria
November 9, 2018
First Posted (Actual)
November 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
November 9, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHCPWDTM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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