Reference: N Engl J Med. 2022 Sep 15;387(11):989-1000
Practice Point: Avoid aggressive IV hydration in patients with acute pancreatitis. Instead, opt for moderate hydration (such as 1.5 mL/kg/hr) to reduce the risk of fluid overload and maybe even improve clinical outcomes.
EBM Pearl: Adequate statistical power is achieved by enrolling enough participants to detect a difference between groups if one exists. However, a study outcome is still valid even if the trial is underpowered if a significant difference is found.
The year is 2012. A patient with non-severe acute pancreatitis is admitted to the hospital. They are made NPO, aggressively fluid resuscitated, and started on systemic opioids. Discharge planning begins around hospital day #6 just as they begin to eat and you start to wean their oxygen.
Fast forward ten years. The same patient is admitted. You open the admission orders and check the boxes for diet-as-tolerated and systemic opioids. You then come to the box marked “lactated Ringer’s solution, 500 mL/hour”, reflecting guideline-directed therapy for aggressive hydration. You pause before checking the box as you recall the recent WATERFALL trial you came across in NEJM that showed evidence of harm with aggressive fluid resuscitation in patients with acute pancreatitis.
You take another look at the study. The open label trial randomized 249 adults with non-severe pancreatitis to receive either aggressive (20 mL/kg bolus followed by 3 mL/kg/hr infusion), or moderate (10 mL/kg bolus only in hypovolemic patients followed by 1.5 mL/kg/hr infusion) fluid resuscitation. Researchers planned to enroll 744 patients but halted enrollment at the first planned interim analysis due to a significant increase in fluid overload in the aggressive hydration arm (20.5% vs 6.3%; adjusted relative risk 2.85, 95% CI 1.36-5.94). There was no significant difference between groups in the primary outcome of progression to moderately-severe or severe pancreatitis, but because the trial only enrolled 249 of the planned 744 patients, it was underpowered. The data collected trended in the direction of better clinical outcomes and shorter hospital stay in the moderate hydration arm (hypothesis-generating only, of course). As an astute clinician, you consider potential threats to validity in the trial, including several baseline differences between groups and the lack of blinding, but conclude the study is moderate-to-high quality evidence.
Do you still check the box for aggressive hydration, or enter a different order for slower fluids? Guidelines strongly recommend aggressive hydration, and all the other hospitalists are practicing this way. Being among the first to implement practice-changing information, especially if you are going against guidelines, is challenging if not scary. After all, clinicians love guidelines because they tell you what to do and offer the support of a group of experts. But you know what? High-quality evidence has your back even more than experts do.
To pioneer practice change, first you need a system for keeping up with emerging evidence, such as using DynaMed or reading email alerts from online journals like JAMA or NEJM. Once you are aware of evidence that differs from current practice recommendations, engage your colleagues in conversations that take the tone of “being curious”. Offer up new information in an effort towards shared learning. You can say, “have you seen the new study about fluid resuscitation for pancreatitis in NEJM? It looks like aggressive hydration might cause more harm than good. I can send you the link.” There is often a lag in awareness of new evidence and most people are eager to learn more when engaged in this way (as opposed to being told they are doing something wrong). If you fear medicolegal repercussions or worry your colleagues might question your ‘rogue’ decision-making, consider including the study citation or link in your documentation. Passive knowledge-sharing reaches more people than you realize. And chances are your colleagues will think even more highly of you for staying on top of medical literature and respect you for your thoughtful and bold evidence-informed clinical practice.
We all make decisions based on the best information available to us at the time. But with new or better information, sometimes the ‘best decision’ must become a different one. So do the harder thing and don’t check the box for aggressive hydration. Be brave enough to enter your own order while you wait for (and encourage) the rest of the medical community to catch up!
For more information, see the topic Acute Pancreatitis in Adults in DynaMed.
DynaMed EBM Focus Editorial Team
This EBM Focus was written by Katharine DeGeorge, MD, MS, Deputy Editor at DynaMed and Associate Professor of Family Medicine at the University of Virginia. Edited by Alan Ehrlich, MD, Executive Editor at DynaMed and Associate Professor in Family Medicine at the University of Massachusetts Medical School; Dan Randall, MD, Deputy Editor at DynaMed; Nicole Jensen, MD, Family Physician at WholeHealth Medical; Vincent Lemaitre, PhD, Senior Medical Writer at DynaMed; and Sarah Hill, MSc, Associate Editor at DynaMed.