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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242473 on ClinicalTrials.gov