CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Fluid Managementother
Likely dose
Not stated in record
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Search/NCT03242473
NCT03242473N/ACompleted

Mitigating the Inflammatory Response in Acute Pancreatitis With Appropriate Fluid Management; A Randomized Clinical Control Trial Comparing the Effects of Lactated Ringers and Normal Saline

Children's Hospital Medical Center, Cincinnati·interventional·Posted Aug 8, 2017·Updated Aug 17, 2021

In Brief

A clinical study evaluating Fluid Management for Pancreatitis. Completed, enrolled 79 participants across 3 sites.

Detailed Summary

Acute pancreatitis is increasingly common diagnosis in children. Most of the guidelines related to the details of management of acute pancreatitis are extrapolated from the adult literature. There is only limited data regarding management of acute pancreatitis in children. The mainstay of management is bowel and pancreatic rest with significant fluid support to minimize the effect of the cytokines on the pancreas and other organs. The standard fluid choices are Lactated Ringer's solution (LR) and normal saline (NS). Currently, both LR and NS are used at the discretion of the treating physician as the standard of care for acute pancreatitis. The investigators hope to examine the question of ideal fluid choice for fluid resuscitation in children with acute pancreatitis by assessing recovery time in the context of measured inflammatory markers and SIRS status at 24 and 48 hours after admission. The ideal fluid choice in the initial resuscitation of acute pancreatitis has not been effectively evaluated before in the pediatric population. Even if there is no statistically significant difference between the two fluid options, this trial will still provide clinically significant information.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatitis
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 8, 2017
Enrollment StartDec 1, 2014
Primary CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 8.9 years ago

Interventions

Fluid Managementother

The patient will remain NPO for at least the first 24 hours. The following studies will be obtained at the time of admission if not previously obtained in the ED: CMP, GGT, Amylase, Lipase, Triglycerides, CBC, and CRP, along with an abdominal ultrasound. CBC, CRP, BMP, amylase and lipase levels will be obtained at 24 and 48 hours (+/- 2 hours). SIRS status will be evaluated with vital sign checks every 4 hours and the leukocyte counts every 24 hours.