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Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited. At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation with lactated Ringer's solution. Aggressive fluid resuscitation consisted of a bolus of 20 ml per kilogram of body weight, followed by 3 ml per kilogram per hour. Moderate fluid resuscitation consisted of a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml per kilogram per hour in all patients in this group. Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to the patient's clinical status. The primary outcome was the development of moderately severe or severe pancreatitis during the hospitalization. The main safety outcome was fluid overload. The planned sample size was 744, with a first planned interim analysis after the enrollment of 248 patients. A total of 249 patients were included in the interim analysis. The trial was halted owing to between-group differences in the safety outcomes without a significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P = 0.32). Fluid overload developed in 20.5% of the patients who received aggressive resuscitation and in 6.3% of those who received moderate resuscitation (adjusted relative risk, 2.85; 95% CI, 1.36 to 5.94, P = 0.004). The median duration of hospitalization was 6 days (interquartile range, 4 to 8) in the aggressive-resuscitation group and 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group. In this randomized trial involving patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes. (Funded by Instituto de Salud Carlos III and others; WATERFALL ClinicalTrials.gov number, NCT04381169.).

Background Recent evidence suggests that acetate-buffered infusions result in better hemodynamic stabilization than 0.9% saline in patients undergoing major surgery. The choice of buffer in balanced crystalloid solutions may modify their hemodynamic effects. We therefore compared the inopressor requirements of Ringer’s acetate and lactate for perioperative fluid management in patients undergoing cardiac surgery. Methods Using a randomized controlled double-blind design, we compared Ringer’s acetate (RA) to Ringer’s lactate (RL) with respect to the average rate of inopressor administered until postoperative hemodynamic stabilization was achieved. Secondary outcomes were the cumulative dose of inopressors, the duration of inopressor administration, the total fluid volume administered, and the changes in acid-base homeostasis. Patients undergoing elective valvular cardiac surgery were included. Patients with severe cardiac, renal, or liver disease were excluded from the study. Results Seventy-five patients were randomly allocated to the RA arm, 73 to the RL. The hemodynamic profiles were comparable between the groups. The groups did not differ with respect to the average rate of inopressors (RA 2.1 mcg/kg/h, IQR 0.5–8.1 vs. RL 1.7 mcg/kg/h, IQR 0.7–8.2, p  = 0.989). Cumulative doses of inopressors and time on individual and combined inopressors did not differ between the groups. No differences were found in acid-base parameters and their evolution over time. Conclusion In this study, hemodynamic profiles of patients receiving Ringer’s lactate and Ringer’s acetate were comparable, and the evolution of acid-base parameters was similar. These study findings should be evaluated in larger, multi-center studies. Trial registration Clinicaltrials.gov NCT02895659 . Registered 16 September 2016.

Background Vasospasms are common in patients presenting with non-traumatic subarachnoid haemorrhage (SAH) and are the main contributor to long-term disability or death in these patients. The key immediate management of vasospasms is the improvement of brain perfusion by the administration of intravenous fluid and vasopressors if needed. Yet, there is no clear recommendation regarding the choice of fluid in this particular patient population. Data suggests a survival benefit using normal saline in patients with TBI; however, its impact on outcomes in patients with SAH is lacking. Thus, the aim of this study is to evaluate whether the use of normal saline reduces clinically relevant vasospasms compared to Ringer’s lactate in patients with SAH. Methods Patients presenting with non-traumatic SAH will be randomised 1:1 to normal saline or Ringer’s lactate group. Blinded study fluid will be used exclusively for resuscitation and maintenance until ICU/IMC discharge or a maximum of 14 days, whichever occurs first. Management of vasospasms and general management of the SAH patient will be according to the clinic standard of care. Primary endpoint is the occurrence of clinically relevant vasospasms. Key secondary outcomes include mortality, severity and treatment of vasospasms, and neurological outcomes at 90 days. Discussion The proposed randomised controlled trial offers a safe, non-invasive way to gain insights about crystalloid fluid choice in SAH patients, with potential to improve outcomes in this critically ill patient group. This study could establish a new gold standard in fluid therapy for neuro-critical care. Trial registration The trial is registered on ClinicalTrials.gov (date of registration 18 June 2021) and on the Swiss National Clinical Trials Portal, SNCTP000004575.

INTRODUCTION:Aggressive hydration using lactated Ringer's solution prevents postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Concerns of this strategy are large volume and lengthy hydration. Our study aimed to evaluate the efficacy of tailored aggressive hydration (TAH) for PEP prevention.METHODS:In this prospective, multicenter, double-blinded, randomized trial conducted across 3 tertiary Korean hospitals, patients who underwent ERCP for the first time were randomly assigned (1:1) to the tailored standard hydration (TSH) and TAH groups. The TSH group received 1.5 mL/kg/hr lactated Ringer's solution during and after ERCP, whereas the TAH group was administered a 20 mL/kg bolus post-ERCP and 3 mL/kg/hr during and after the procedure. Both groups were assessed for elevated serum amylase levels and pain 4-6 hours after ERCP. If both were absent, hydration was discontinued. If either was present, hydration was continued at the original rate until 8 hours. The primary end point was PEP development and was analyzed on an intention-to-treat analysis.RESULTS:A total of 344 patients were randomly assigned to treatment groups (171 to the TSH group and 172 to the TAH group). PEP was observed in 9.4% (16/171) in the TSH group and 3.5% (6/172) in the TAH group (relative risk 0.37, 95% confidence interval 0.15-0.93, P = 0.03). No difference was identified between the 2 groups in PEP severity (P = 0.80) and complications related to volume overload (P = 0.32).DISCUSSION:TAH according to the presence of abdominal pain or elevated serum amylase levels at 4-6 hours after ERCP is safe and prevents PEP development.

In this cluster-randomized, crossover trial, hospital-wide use of lactated Ringer’s solution as compared with normal saline did not alter the incidence of death or hospital readmission within 90 days.

Acute pancreatitis (AP) is a common presentation in patients admitted with acute abdomen. Whether Ringers lactate (RL) or Normal Saline (NS) as a resuscitation fluid is better still remains unclear. The aim of this study is to compare the efficacy of RL and NS in terms of control of systemic inflammation by measuring indirect markers specifically Systemic Inflammation Response Syndrome (SIRS) scores and C- Reactive Protein (CRP) level. This was an open label randomized trial conducted in a tertiary level hospital of Nepal. Ethical approval was obtained prior to the study. Patients with acute pancreatitis were randomized to either RL or NS group for the fluid resuscitation. The fluid was given as per the study protocol for three days for hydration. Baseline SIRS and CRP were recorded on admission and subsequently as defined. All the data were analyzed using SPSS ver 20.0 software. Total 51 patients were enrolled, 26 in RL and 25 in NS group. The commonest etiology of AP was alcohol (84.31%). SIRS was present in 46.2% and 64.0% of patients in RL and NS group respectively (p = 0.20) on admission. At least one SIRS criteria was still present in 44.0% of patients in the NS group compared to only 15.4% in the RL group after 24 hours (p = 0.025). The baseline CRP were comparable in both the groups. However after 72 hours, the increment of CRP was more in the NS group compared to the RL group; median value of 14.2 mg/dl (12.15, 16.45) and 22.2 mg/dl (18.20, 30.60) in RL and NS group respectively (p<0.001). Ringers lactate was associated with a reduction in systemic inflammation compared to normal saline in patients with acute pancreatitis. Incidence of SIRS at 72 hours and occurrence of local complications were however similar in both the groups.

Background Some evidence suggests that fluid resuscitation with lactated Ringer’s solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS) and may be associated with a decrease in severity, but existing single-center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP. Methods The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 h. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP. A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level. Discussion The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease. Trial registration ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023–000010-18, first posted March 23, 2023.

Background Volume replacement with crystalloid fluid is the conventional treatment of hemorrhage. We challenged whether a standardized amount of 5% or 20% albumin could be a viable option to maintain the blood volume during surgery associated with major hemorrhage. Therefore, the aim of this study was to quantify and compare the plasma volume expansion properties of 5% albumin, 20% albumin, and Ringer-lactate, when infused during major surgery. Methods In this single-center randomized controlled trial, fluid replacement therapy to combat hypovolemia during the hemorrhagic phase of cystectomy was randomly allocated in 42 patients to receive either 5% albumin (12 mL/kg) or 20% albumin (3 mL/kg) over 30 min at the beginning of the hemorrhagic phase, both completed by a Ringer-lactate replacing blood loss in a 1:1 ratio, or Ringer-lactate alone to replace blood loss in a 3:1 ratio. Measurements of blood hemoglobin over 5 h were used to estimate the effectiveness of each fluid to expand the blood volume using the following regression equation: blood loss plus blood volume expansion = factor + volume of infused albumin + volume of infused Ringer-lactate. Results The median hemorrhage was 848 mL [IQR: 615–1145]. The regression equation showed that the Ringer-lactate solution expanded the plasma volume by 0.18 times the infused volume while the corresponding power of 5% and 20% albumin was 0.74 and 2.09, respectively. The Ringer-lactate only fluid program resulted in slight hypovolemia (mean, − 313 mL). The 5% and 20% albumin programs were more effective in filling the vascular system; this was evidenced by blood volume changes of only + 63 mL and − 44 mL, respectively, by long-lasting plasma volume expansion with median half time of 5.5 h and 4.8 h, respectively, and by an increase in the central venous pressure. Conclusion The power to expand the plasma volume was 4 and almost 12 times greater for 5% albumin and 20% albumin than for Ringer-lactate, and the effect was sustained over 5 h. The clinical efficacy of albumin during major hemorrhage was quite similar to previous studies with no hemorrhage. Trial registration : ClinicalTrials.gov NCT05391607, date of registration May 26, 2022.

Background Fluid loading with crystalloids is the conventional treatment of major hemorrhage but might tend to create fluid overload. We studied hemodynamic profiles of fluid replacement therapies during major surgical hemorrhage and compared the ability of pulse pressure variation (PPV), plethysmographic variation index (PVI), cardiac output (CO) and Guyton´s approach to detect hypovolemia. Methods In this single center randomized controlled trial, fluid replacement therapy to treat hemorrhage in 42 patients was randomized to consist of either 5% albumin (12 mL/kg) or 20% albumin (3 mL/kg) over 30 min, both completed by Ringer lactate replacing blood loss in a 1:1 ratio, or Ringer solution alone in a 3:1 ratio. Measurements included CO, PPV, PVI, arterial and central venous pressures, heart rate (HR) and subsequent calculation of Guyton´s physiological parameters. CO was measured by an esophageal Doppler probe. Results The Ringer-only fluid program resulted in slight hypovolemia (mean, 313 mL), decreased mean arterial pressure (MAP), increased HR, PPV values and vasopressor requirement. The 5% and 20% albumin programs were more effective in filling the vascular system, as evidenced by higher mean circulatory filling pressure and unchanged or decreased PPV over the 5 h observation period. The 20% albumin increased the systemic vascular resistance and the resistance to venous return. Receiver operating characteristics curves indicated that hypovolemia > 500 mL could only be accurately detected by PPV when 5% albumin was used, that PVI was reliable when Ringer was infused, and that CO indicated the hypovolemia when 20% albumin was administered. Conclusions The trends in PPV, PVI, and CO reflected the changes in intravascular volume, but how well they indicated hypovolemia > 500 mL may differ depending on the choice of infusion fluid. Identifying hypovolemia using non-invasive hemodynamic monitors remains challenging and associated with low predictive values. Trial registration number: NCT05391607, May 26, 2022.

Postoperative acute kidney injury (AKI) is common after non-cardiac surgery. Normal saline and lactated Ringer's solution are both used for volume replacement during surgery. Normal saline decreases renal blood flow and causes hyperchloremic acidosis whereas lactated Ringer's does not. The incidence of AKI is similar with modest volumes of each fluid. But it remains unclear whether larger volumes of normal saline provoke AKI. Evaluate whether intraoperative crystalloid volume modifies the relationship between the AKI risk and treatment group. Secondary analysis of a single-center multiple cross-over cluster trial. Intraoperative care. We enrolled 8616 adults who had colorectal or orthopedic surgery at a large academic institution. Clusters of patients were alternately assigned to intraoperative normal saline or lactated Ringer's solution. The primary outcome was the incidence of acute kidney injury (AKI) as a function of intraoperative crystalloid volume (0–1, 1–2, 3–4, or 4+ liters) and the type of crystalloid. Our secondary outcome was the change in postoperative serum chloride concentration during the first 24 h. The risk of AKI did not differ significantly in patients given 0–1, 1–2, or 3–4 L saline or lactated Ringers solutions. In contrast, patients given 2–3 or > 4 L of lactated Ringer's solution had a higher risk of AKI than those given saline. Patients assigned to normal saline had progressively greater plasma chloride concentrations than those given lactated Ringer's across all volume categories. While saline administration clearly causes volume-dependent hyperchloremia, we found no evidence to support the theory that large volumes of saline provoke AKI. Therefore, either fluid seems reasonable for intraoperative use. •The incidence of AKI is similar with modest volumes of normal saline and lactated Ringer's solutions, but it remains unclear whether larger volumes of normal saline provoke AKI.•In a multiple cross-over cluster trial, 8616 patients were assigned to normal saline and lactated Ringer's solutions. Patients given 2–3 or > 4 L of lactated Ringer's solution had a higher risk of AKI than those given saline.•Normal saline and lactated Ringer's solutions both seem reasonable for intraoperative use.