Lactated Ringer's Versus Normal Saline for Acute Pancreatitis

Completed · Not applicable

Conditions studied: Pancreatitis, Acute

In brief

Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis. The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis. Patients presenting to the Los Angeles County Hospital with acute pancreatitis will be randomized to fluid resuscitation with NS or LR with volumes of fluid administered according to a pre-determined algorithm that will be the same for both treatment arms. The primary outcome of the study will be the change in SIRS prevalence from enrollment to 24 hours. Secondary outcomes will include the change in SIRS prevalence from enrollment to 48 hours and 72 hours, development of moderately severe or severe pancreatitis, change in PASS score, ICU admission, length of hospitalization, persistent pain or disability after discharge, and time of advancement to oral diet and discharge.

Key facts

Study ID

NCT03642769

Run by

University of Southern California

People needed

121

Starts

2018-09-18

Expected to finish

2021-08-16

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase > 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding.

You may not qualify if…

• Patients with severe pancreatitis as defined by the Revised Atlanta Classification will be excluded. Severe pancreatitis is defined by the Revised Atlanta Classification as those with a Modified Marshall score of >2 for their cardiovascular renal, or respiratory system will be excluded (Figure 2).13 Practically this includes patients with systolic blood pressure <90, serum creatinine >1.9, and PaO2/FiO2 <300 (Figure 3). Since blood gases are unlikely to be drawn on those with mild pancreatitis we will exclude patients with an oxygen saturation <92% on room air and certainly any patients which require intubation for respiratory failure due to pancreatitis.
• Patients who cannot tolerate increased doses of fluids for other reasons will also be excluded. This consists of those with cardiac insufficiency (CI, >NYHA Class II heart failure), pulmonary edema, dialysis requirement, or severe liver dysfunction (albumin < 3mg/dL, known cirrhosis).
• Pregnant women will also be excluded as they are prone to retain sodium and water, which puts them at increased risk of pulmonary congestion, ascites or peripheral edema.
• Patients who are incarcerated, younger than eighteen, or unable to give informed consent will be excluded.
• Individuals who present with clinical signs of edema or anasacra, including pulmonary congestion, peripheral swelling, and ascites, will also be ineligible for the study.
• Administration of fluids prior to the enrollment in the study will not be an exclusion criterion as this reflects actual clinical practice (hydration during evaluation period) however all fluids given prior to the study will be meticulously recorded.

Where it is running

• LAC+USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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