Comparative Study between Restrictive versus Liberal Intravenous Fluid Administration in Severe Sepsis and Septic Shock; A Randomized Clinical Trial

Abstract

Abstract Background Sepsis is an inflammatory response to severe infection characterized by hypovolemia and vasodilation and treated with early antibiotics and fluid resuscitation. In-hospital mortality rates have decreased from 80% in the early years of intensive care to 20-30% in the modern era through improved surveillance, early treatment of underlying infection, and advances in support for failing organs. Despite the central role intravenous (IV) fluid administration has played in sepsis management for the last 15 years, fundamental questions regarding “which fluid” and “in what amount” remain unanswered. Objective To compare between the outcomes of fluid administration strategies in the form of restricted or usual fluid administration in patient with severe sepsis and septic shock, and to detect the optimal strategy of fluid administration which decreases morbidity and mortality. Patients and Methods This was a Prospective controlled; randomized, comparative study was conducted in the intensive care units at Ain-Shams University Hospitals and Gamal Abdelnaser Hospital. This study was conducted on 80 adult patients divided into two groups: Group A: 40 adult patients taking the Usual Care, and Group B: 40 adult patients taking the Restrictive Care. Results The restrictive fluid group received significantly less resuscitative IV fluid than the usual care group prior to randomization, over 24 hours, over 48 hours, over 72 hours and total, Moreover; the restrictive fluid group also received a lower fraction of non-resuscitative IV fluid than the usual care group. In addition, the restrictive fluid group also received less amount of total forms IV fluid than the usual care group. There were no statistically significant differences between the two groups in adjunct resuscitative measures administered including albumin, blood transfusion, or stress dose steroids. By day 30, 9 participants (22.5%) in the restrictive fluid group and 7 participants (17.5%) in the usual care had died with no statistical significant difference between the both groups (p = 0.29). Conclusion A restrictive resuscitation strategy that significantly limited the amount of IV fluid administered to patients with severe sepsis and septic shock show slight improvement as regard mean arterial blood pressure, urine output and lactate level. at the same time did not appear to increase mortality, organ dysfunction, or adverse events. Our data contribute to the current state of clinical equipoise surrounding the use of IV fluids in sepsis, support a larger multicenter trial addressing this topic, and inform future study design. This study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. Although limited by the sample size, we observed no increase in mortality, organ failure, or adverse events.