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Comparing the Effects of Lactated Ringers and Normal Saline in Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT03242473
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Children's Research Institute
Information provided by (Responsible Party):
Peter Farrell, Children's Hospital of The King's Daughters

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Other: Fluid Management Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Lactated Ringers (LR)
The subject will be placed on 1.5x maintenance IVF with the fluids to which they are randomized. Fluid Management will be the intervention.
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.
Other Name: Resuscitative fluids for acute pancreatitis

Experimental: Normal Saline (NS)
The subject will be placed on 1.5x maintenance IVF with the fluids to which they are randomized. Fluid Management will be the intervention.
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.
Other Name: Resuscitative fluids for acute pancreatitis




Primary Outcome Measures :
  1. C-Reactive Protein (CRP) [ Time Frame: At admission, 24 and 48 hours ]
    Primary marker of inflammation, change measured at baseline and then every 24 hours for 48 hours


Secondary Outcome Measures :
  1. Blood Urea Nitrogen (BUN) [ Time Frame: At admission, 24 and 48 hours ]
    Trend BUN

  2. Serum Amylase [ Time Frame: At admission, 24 and 48 hours ]
    Trend Amylase over the course of the admission

  3. Serum Lipase [ Time Frame: At admission, 24 and 48 hours ]
    Trend Lipase over the course of the admission

  4. Average length of stay [ Time Frame: Total length of stay in the hospital, measured in hours, usually around 4 days (96 hours). ]
    Total length of stay in the hospital

  5. Time to initiation of enteral feeds [ Time Frame: Total length of time to initiate feeds in the hospital, measured in hours, usually around 2 days (48 hours). ]
    Total time required to start oral feeds as defined by placement of order to start feeds

  6. SIRS Criteria [ Time Frame: At admission, 24 and 48 hours ]
    Signs of Systemic Inflammatory Response Syndrome (SIRS) as defined by Goldstein et al will be compared.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 0-18 years diagnosed with acute pancreatitis in the emergency department or inpatient ward at Children's Hospital of The King's Daughters or one of the affiliated institutions participating in the study.

Exclusion Criteria:

  • Patients greater than 18 years of age
  • Patients who are not diagnosed with acute pancreatitis
  • Patients who have any previous history of acute pancreatitis, past medical history of underlying illness including congenital heart disease, chronic lung disease, or renal failure
  • Patients who have any of the following: hyperkalemia, systemic acidosis, acute dehydration, extensive tissue breakdown, adrenal insufficiency, concomitant use of potassium-sparing diuretics, use of extended-release preparations in patients with esophageal compression caused by an enlarged left atrium, hypersensitivity to sodium chloride, hypernatremia, or fluid retention
  • Patients who are pregnant females
  • Patients who have additional comorbidities at time of admission that would prevent adequate treatment with the methods described above will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242473


Contacts
Contact: Peter R Farrell, MD 917-696-5731 peter.farrell@cchmc.org

Locations
United States, District of Columbia
Children's National Health System Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Sona Sehgal, MD    888-884-2327    SSehgal@childrensnational.org   
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Peter R Farrell, MD    917-696-5731    peter.farrell@cchmc.org   
Sponsors and Collaborators
Children's Hospital of The King's Daughters
Children's Research Institute
Investigators
Principal Investigator: Peter R Farrell, MD Children's Hospital of The King's Daughters
Principal Investigator: Sona Sehgal, MD Children's National Health System

Publications:
Responsible Party: Peter Farrell, Chief Resident, Department of Pediatrics, Children's Hospital of The King's Daughters
ClinicalTrials.gov Identifier: NCT03242473     History of Changes
Other Study ID Numbers: 14-12-FB-0245
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share the data obtained at CHKD with our partners at Children's National Medical Center, and we intend to have them share their data with us as well.

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases