Pancreatitis, AcuteNCT03740685
Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis
An observational study of Pancreatitis, Acute, run by Assiut University at 1 site in Egypt.
Trial summary
changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- High sesitive C reactive protien
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2018to 8 Oct 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute pancreatitis
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis
- Conditions
- Pancreatitis, Acute
- Being tested
- High sesitive C reactive protien
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High sesitive C reactive protienDiagnostic test
High sesitive C reactive protien will be evaluated at admission time and after 36 hours
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute pancreatitis | All patients will recive different lines of treatment {saline,antibiotics,dexamethasone} Receives: Diagnostic Test: High sesitive C reactive protien |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sesitive C reactive protien
Level of High sesitive C reactive protien expected to be changed with different lines of treatment and will be compaered
Measured: 72hours
Serum Amylase
Level of Serum Amylase expected to be changed with different lines of treatment and will be compaered
Measured: 72hours
Serum Lipase
Level of Serum Lipase expected to be changed with different lines of treatment and will be compaered
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start9 Nov 2018 (estimated)
- Primary completion9 Nov 2018 (estimated)
- Study completion8 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelhamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740685
- Sponsor's protocol ID
- CHCPWDTM
- Status last verified
- Nov 2018
- First submitted
- 11 Oct 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in High Sensitive C Reactive Protien With Different Treatment Modalities in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03740685
- Acronym / sponsor ID
- CHCPWDTM
- Conditions
- Pancreatitis, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 9 Nov 2018 (estimated)
- Primary completion
- 9 Nov 2018 (estimated)
- Study completion
- 8 Oct 2019 (estimated)
- First posted
- 14 Nov 2018 (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.
changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute pancreatitis | – | Diagnostic Test: High sesitive C reactive protienAll patients will recive different lines of treatment {saline,antibiotics,dexamethasone} |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute pancreatitis
Key inclusion criteria (6 listed)
- Age>=18 years
- Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| High sesitive C reactive protienHigh sesitive C reactive protien will be evaluated at admission time and after 36 hours | Diagnostic test | Patients with acute pancreatitis |
Primary outcome
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
Serum Amylase
Time frame: 72hours
Level of Serum Amylase expected to be changed with different lines of treatment and will be compaered
Serum Lipase
Time frame: 72hours
Level of Serum Lipase expected to be changed with different lines of treatment and will be compaered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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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.
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 Pancreatitis, Acute, 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 6 inclusion and 13 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 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud Abd Elhamed, principal participant (01017141345, mahmoudsisi100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sesitive C reactive protien (time frame: 72hours). The study lists 3 primary outcomes in all. 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 Nov 2018.