Comparing the Effects of Lactated Ringers and Normal Saline in Acute Pancreatitis
NCT03242473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2021-08-17
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.
Conditions
Interventions
- OTHER
-
Fluid Management
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.
Sponsors & Collaborators
-
Children's National Research Institute
collaborator OTHER -
Children's Hospital of The King's Daughters
collaborator OTHER -
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Peter R Farrell, MD · Children's Hospital Medical Center, Cincinnati
-
Sona Sehgal, MD · Children's National Research Institute
-
Rana Ammoury, MD · Children's Hospital of The King's Daughters
-
Maisam Abu-El-Haija, MD · Children's Hospital Medical Center, Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2020-10-23
- Completion
- 2020-10-23
Countries
- United States
Study Locations
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