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

NCT03242473 | Completed DMC

• 1 other identifier: 14-12-FB-0245
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein (CRP)

  Primary marker of inflammation, change measured at baseline and then every 24 hours for 48 hours

  At admission, 24 and 48 hours

Secondary Outcomes (6)

• Blood Urea Nitrogen (BUN)

  At admission, 24 and 48 hours

• Serum Amylase

  At admission, 24 and 48 hours

• Serum Lipase

  At admission, 24 and 48 hours

• Average length of stay

  Total length of stay in the hospital, measured in hours, usually around 4 days (96 hours).

• Time to initiation of enteral feeds

  Total length of time to initiate feeds in the hospital, measured in hours, usually around 2 days (48 hours).

Study Arms (2)

Lactated Ringers (LR)

EXPERIMENTAL

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

Normal Saline (NS)

EXPERIMENTAL

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

Interventions

Fluid Management OTHER

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.

Also known as: Resuscitative fluids for acute pancreatitis

Lactated Ringers (LR); Normal Saline (NS)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Children's National Research Institute: collaborator
• Children's Hospital of The King's Daughters: collaborator

Study Sites (3)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (6)

• Srinath AI, Lowe ME. Pediatric pancreatitis. Pediatr Rev. 2013 Feb;34(2):79-90. doi: 10.1542/pir.34-2-79. No abstract available.

  PMID: 23378615 BACKGROUND

• Sarr MG. Early fluid "resuscitation/therapy" in acute pancreatitis: which fluid? What rate? What parameters to gauge effectiveness? Ann Surg. 2013 Feb;257(2):189-90. doi: 10.1097/SLA.0b013e318280e19e. No abstract available.

  PMID: 23291660 BACKGROUND

• Meyer A, Coffey MJ, Oliver MR, Ooi CY. Contrasts and comparisons between childhood and adult onset acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4):429-35. doi: 10.1016/j.pan.2013.06.005. Epub 2013 Jun 27.

  PMID: 23890143 BACKGROUND

• Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.

  PMID: 21645639 BACKGROUND

• Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.

  PMID: 15636651 BACKGROUND

• Farrell PR, DesPain AW, Farmer P, Farrell LM, Greenfield B, Rogers ME, Hornung L, Kim E, Pearman R, Neway B, Thompson T, Heubi JE, Sehgal S, Amoury R, Abu-El-Haija M. Faster discharge with lactated ringers than normal saline in first 72 h of acute pancreatitis: A multicenter randomized trial. J Pediatr Gastroenterol Nutr. 2024 Feb;78(2):360-368. doi: 10.1002/jpn3.12082. Epub 2023 Dec 11.

  PMID: 38374568 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Peter R Farrell, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Sona Sehgal, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Rana Ammoury, MD

  Children's Hospital of The King's Daughters

  PRINCIPAL INVESTIGATOR

• Maisam Abu-El-Haija, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 8, 2017
• Study Start: December 1, 2014
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be shared for up to 3 years after the conclusion of recruitment.

Locations

US (3)