NCT03740685

Brief Summary

changes in high sensitive C reactive protien with different treatment modalities in acute pancreatitis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 11, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

October 11, 2018

Last Update Submit

November 9, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    72hours

  • Serum Amylase

    Level of Serum Amylase expected to be changed with different lines of treatment and will be compaered

    72hours

  • Serum Lipase

    Level of Serum Lipase expected to be changed with different lines of treatment and will be compaered

    72hours

Study Arms (1)

Patients with acute pancreatitis

All patients will recive different lines of treatment {saline,antibiotics,dexamethasone}

Diagnostic Test: High sesitive C reactive protien

Interventions

High sesitive C reactive protien will be evaluated at admission time and after 36 hours

Patients with acute pancreatitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute pancreatitis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

mahmoud Abd Elhamed, principal participant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

November 14, 2018

Study Start

November 9, 2018

Primary Completion

November 9, 2018

Study Completion

October 8, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations