-
1.
Association of Positive Fluid Balance at Discharge After Sepsis Management With 30-Day Readmission.
Yoo, MS, Zhu, S, Lu, Y, Greene, JD, Hammer, HL, Iberti, CT, Nemazie, S, Ananias, MP, McCarthy, CM, O'Malley, RM, et al
JAMA network open. 2021;(6):e216105
Abstract
IMPORTANCE Although early fluid administration has been shown to lower sepsis mortality, positive fluid balance has been associated with adverse outcomes. Little is known about associations in non-intensive care unit settings, with growing concern about readmission from excess fluid accumulation in patients with sepsis. OBJECTIVE To evaluate whether positive fluid balance among non-critically ill patients with sepsis was associated with increased readmission risk, including readmission for heart failure. DESIGN, SETTING, AND PARTICIPANTS This multicenter retrospective cohort study was conducted between January 1, 2012, and December 31, 2017, among 57 032 non-critically ill adults hospitalized for sepsis at 21 hospitals across Northern California. Kaiser Permanente Northern California is an integrated health care system with a community-based population of more than 4.4 million members. Statistical analysis was performed from January 1 to December 31, 2019. EXPOSURES Intake and output net fluid balance (I/O) measured daily and cumulatively at discharge (positive vs negative). MAIN OUTCOMES AND MEASURES The primary outcome was 30-day readmission. The secondary outcomes were readmission stratified by category and mortality after living discharge. RESULTS The cohort included 57 032 patients who were hospitalized for sepsis (28 779 women [50.5%]; mean [SD] age, 73.7 [15.5] years). Compared with patients with positive I/O (40 940 [71.8%]), those with negative I/O (16 092 [28.2%]) were older, with increased comorbidity, acute illness severity, preexisting heart failure or chronic kidney disease, diuretic use, and decreased fluid administration volume. During 30-day follow-up, 8719 patients (15.3%) were readmitted and 3639 patients (6.4%) died. There was no difference in readmission between patients with positive vs negative I/O (HR, 1.00; 95% CI, 0.95-1.05). No association was detected between readmission and I/O using continuous, splined, and quadratic function transformations. Positive I/O was associated with decreased heart failure-related readmission (HR, 0.80 [95% CI, 0.71-0.91]) and increased 30-day mortality (HR, 1.23 [95% CI, 1.15-1.31]). CONCLUSIONS AND RELEVANCE In this large observational study of non-critically ill patients hospitalized with sepsis, there was no association between positive fluid balance at the time of discharge and readmission. However, these findings may have been limited by variable recording and documentation of fluid intake and output; additional studies are needed to examine the association of fluid status with outcomes in patients with sepsis to reduce readmission risk.
-
2.
Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial.
Sperna Weiland, CJ, Smeets, XJNM, Kievit, W, Verdonk, RC, Poen, AC, Bhalla, A, Venneman, NG, Witteman, BJM, da Costa, DW, van Eijck, BC, et al
The lancet. Gastroenterology & hepatology. 2021;(5):350-358
Abstract
BACKGROUND Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. METHODS FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. FINDINGS Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). INTERPRETATION Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. FUNDING Netherlands Organisation for Health Research and Development and Radboud University Medical Center.
-
3.
Fluid balance and outcome in critically ill patients with traumatic brain injury (CENTER-TBI and OzENTER-TBI): a prospective, multicentre, comparative effectiveness study.
Wiegers, EJA, Lingsma, HF, Huijben, JA, Cooper, DJ, Citerio, G, Frisvold, S, Helbok, R, Maas, AIR, Menon, DK, Moore, EM, et al
The Lancet. Neurology. 2021;(8):627-638
-
-
Free full text
-
Abstract
BACKGROUND Fluid therapy-the administration of fluids to maintain adequate organ tissue perfusion and oxygenation-is essential in patients admitted to the intensive care unit (ICU) with traumatic brain injury. We aimed to quantify the variability in fluid management policies in patients with traumatic brain injury and to study the effect of this variability on patients' outcomes. METHODS We did a prospective, multicentre, comparative effectiveness study of two observational cohorts: CENTER-TBI in Europe and OzENTER-TBI in Australia. Patients from 55 hospitals in 18 countries, aged 16 years or older with traumatic brain injury requiring a head CT, and admitted to the ICU were included in this analysis. We extracted data on demographics, injury, and clinical and treatment characteristics, and calculated the mean daily fluid balance (difference between fluid input and loss) and mean daily fluid input during ICU stay per patient. We analysed the association of fluid balance and input with ICU mortality and functional outcome at 6 months, measured by the Glasgow Outcome Scale Extended (GOSE). Patient-level analyses relied on adjustment for key characteristics per patient, whereas centre-level analyses used the centre as the instrumental variable. FINDINGS 2125 patients enrolled in CENTER-TBI and OzENTER-TBI between Dec 19, 2014, and Dec 17, 2017, were eligible for inclusion in this analysis. The median age was 50 years (IQR 31 to 66) and 1566 (74%) of patients were male. The median of the mean daily fluid input ranged from 1·48 L (IQR 1·12 to 2·09) to 4·23 L (3·78 to 4·94) across centres. The median of the mean daily fluid balance ranged from -0·85 L (IQR -1·51 to -0·49) to 1·13 L (0·99 to 1·37) across centres. In patient-level analyses, a mean positive daily fluid balance was associated with higher ICU mortality (odds ratio [OR] 1·10 [95% CI 1·07 to 1·12] per 0·1 L increase) and worse functional outcome (1·04 [1·02 to 1·05] per 0·1 L increase); higher mean daily fluid input was also associated with higher ICU mortality (1·05 [1·03 to 1·06] per 0·1 L increase) and worse functional outcome (1·04 [1·03 to 1·04] per 1-point decrease of the GOSE per 0·1 L increase). Centre-level analyses showed similar associations of higher fluid balance with ICU mortality (OR 1·17 [95% CI 1·05 to 1·29]) and worse functional outcome (1·07 [1·02 to 1·13]), but higher fluid input was not associated with ICU mortality (OR 0·95 [0·90 to 1·00]) or worse functional outcome (1·01 [0·98 to 1·03]). INTERPRETATION In critically ill patients with traumatic brain injury, there is significant variability in fluid management, with more positive fluid balances being associated with worse outcomes. These results, when added to previous evidence, suggest that aiming for neutral fluid balances, indicating a state of normovolaemia, contributes to improved outcome. FUNDING European Commission 7th Framework program and the Australian Health and Medical Research Council.
-
4.
Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.
Aaen, AA, Voldby, AW, Storm, N, Kildsig, J, Hansen, EG, Zimmermann-Nielsen, E, Jensen, KM, Tibæk, P, Mortensen, A, Møller, AM, et al
British journal of anaesthesia. 2021;(4):521-531
-
-
Free full text
-
Abstract
BACKGROUND More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group). METHODS In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications. RESULTS In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found. CONCLUSION Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay. CLINICAL TRIAL REGISTRATION EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
-
5.
Effect of Early Balanced Crystalloids Before ICU Admission on Sepsis Outcomes.
Jackson, KE, Wang, L, Casey, JD, Bernard, GR, Self, WH, Rice, TW, Semler, MW, ,
Chest. 2021;(2):585-595
-
-
Free full text
-
Abstract
BACKGROUND Studies suggest that using balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) rather than saline (0.9% sodium chloride) may improve outcomes for patients with sepsis in the ED and ICU. RESEARCH QUESTION What is the relative impact on sepsis outcomes of fluid composition during early resuscitation in the ED vs after ICU admission? STUDY DESIGN AND METHODS We performed a secondary analysis of the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) data set, examining medical ICU patients with a diagnosis of sepsis (n = 1,641). SMART was a cluster-crossover trial comparing balanced crystalloids vs saline among critically ill adults. During the first 7 months of SMART, fluid choice was controlled only in the ICU ("ICU-only period"). In the final 15 months, fluid choice was coordinated between the ED and ICU ("ED and ICU period"). We performed logistic regression modeling for 30-day in-hospital mortality with an interaction term between randomized group (balanced crystalloids vs saline) and study period (ICU-only period vs ED and ICU period). RESULTS Three hundred and sixty-seven patients with sepsis were enrolled during the ICU-only period and 1,274 were enrolled during the ED and ICU period. Thirty-day in-hospital mortality occurred in 47 of 142 patients (33.1%) in the balanced crystalloid group vs 74 of 225 patients (32.9%) in the saline group during the ICU-only period (OR, 1.14; 95% CI, 0.70-1.88) and in 170 of 682 patients (24.9%) in the balanced crystalloid group vs 181 of 592 patients (30.6%) in the saline group in the ED and ICU period (OR, 0.68; 95% CI, 0.52-0.89) (P value for interaction, .07), consistent with a beneficial effect of balanced crystalloid primarily in the ED and ICU period. INTERPRETATION Among patients with sepsis, the effect of balanced crystalloids vs saline on mortality was greater among patients for whom fluid choice was controlled starting in the ED compared with starting in the ICU.
-
6.
Early Feeding in Acute Pancreatitis in Children: A Randomized Controlled Trial.
Ledder, O, Duvoisin, G, Lekar, M, Lopez, RN, Singh, H, Dehlsen, K, Lev-Tzion, R, Orlanski-Meyer, E, Shteyer, E, Krishnan, U, et al
Pediatrics. 2020;(3)
Abstract
BACKGROUND Studies have increasingly challenged the traditional management of acute pancreatitis (AP) with bowel rest. However, these studies used a low-fat diet or transgastric feeding and only included adults. Aiming to generate higher-quality prospective pediatric data, we compared the traditional approach of fasting and intravenous fluids and early enteral feeding with standard diet or formula. METHODS Randomized controlled trial of children (2-18 years) with mild-moderate AP. Patients were randomly assigned 1:1 to initial fasting and intravenous fluids or an immediate, unrestricted diet. Pain scores, blood measures, and cross-sectional imaging were recorded throughout admission and follow-up. The primary outcome was time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates. RESULTS Of 33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45%) were randomly assigned to initial fasting. We recorded the median (interquartile range [IQR]) time to discharge (2.6 [IQR 2.0 to 4.0] vs 2.9 [IQR 1.8 to 5.6]; P = .95), reduction in serum lipase levels by day 2 (58% [IQR 2% to 85%] vs 48% [IQR 3% to 71%]; P = .65), and readmission rates (1 of 18 [6%] vs 2 of 15 [13%]; P = .22) between the early feeding and fasting cohorts, respectively. Immediate or delayed complication rates did not differ. Patients randomly assigned to early feeding had weight gain of 1.3 kg (IQR 0.29 to 3.6) at follow-up, compared with weight loss of 0.8 kg (IQR -2.1 to 0.7) in fasted patients (P = .028). CONCLUSIONS This is the first randomized controlled trial in pediatric AP. There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.
-
7.
Hypertension during Diabetic Ketoacidosis in Children.
DePiero, A, Kuppermann, N, Brown, KM, Schunk, JE, McManemy, JK, Rewers, A, Stoner, MJ, Tzimenatos, L, Garro, A, Myers, SR, et al
The Journal of pediatrics. 2020;:156-163.e5
-
-
Free full text
-
Abstract
OBJECTIVES To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension. STUDY DESIGN This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in DKA Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension. RESULTS Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower pCO2), and stage 2 or 3 acute kidney injury. More severe acidosis and lower Glasgow Coma Scale scores were associated with hypertension occurring at any time during DKA treatment. CONCLUSIONS Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower pCO2, and lower Glasgow Coma Scale scores during DKA treatment, suggesting that hypertension might be centrally mediated.
-
8.
Effect of Intraoperative Goal-directed Balanced Crystalloid versus Colloid Administration on Major Postoperative Morbidity: A Randomized Trial.
Kabon, B, Sessler, DI, Kurz, A, ,
Anesthesiology. 2019;(5):728-744
-
-
Free full text
-
Abstract
BACKGROUND Crystalloid solutions leave the circulation quickly, whereas colloids remain for hours, thus promoting hemodynamic stability. However, colloids are expensive and promote renal toxicity in critical care patients. This study tested the hypothesis that goal-directed colloid administration during elective abdominal surgery decreases 30-day major complications more than goal-directed crystalloid administration. METHODS In this parallel-arm double-blinded multicenter randomized trial, adults having moderate- to high-risk open and laparoscopically assisted abdominal surgery with general anesthesia were randomly assigned to Doppler-guided intraoperative volume replacement with 6% hydroxyethyl starch 130/0.4 (n = 523) or lactated Ringer's solution (n = 534). The primary outcome was a composite of serious postoperative cardiac, pulmonary, infectious, gastrointestinal, renal, and coagulation complications that were assessed with a generalized estimating equation multivariate model. The primary safety outcome was a change in serum creatinine concentration up to 6 months postoperatively, compared to baseline concentrations. RESULTS A total of 1,057 patients were included in the analysis. Patients assigned to crystalloid received a median [quartile 1, quartile 3] amount of 3.2 l [2.3, 4.4] of crystalloid, and patients assigned to colloid received 1.0 l [0.5, 1.5] of colloid and 1.8 l [1.2, 2.4] of crystalloid. The estimated intention-to-treat common effect relative risk for the primary composite was 0.90 for colloids versus crystalloids (95% CI: 0.65 to 1.23, P = 0.51), and 18% (91 of 523) of colloid patients and 20% (103 of 534) of crystalloid patients incurred at least one component of the primary outcome composite. There was no evidence of renal toxicity at any time. CONCLUSIONS Doppler-guided intraoperative hydroxyethyl starch administration did not significantly reduce a composite of serious complications. However, there was also no indication of renal or other toxicity.
-
9.
Reversal of Lower-Extremity Intermittent Claudication and Rest Pain by Hydration.
Fernández, S, Parodi, JC, Moscovich, F, Pulmari, C
Annals of vascular surgery. 2018;:1-7
Abstract
BACKGROUND Medical treatment of disabling intermittent claudication or critical limb-threatening ischemia causing rest pain often fails or has partial response. METHODS In this pilot study, 36 patients (12 females) affected by disabling intermittent claudication or rest pain of the lower extremities were exposed to a daily 3-L water intake for up to 6 weeks. Cutaneous foot temperature, ankle/brachial index, time and distance of claudication, and pain intensity were recorded before and at the completion of the hydration period. RESULTS Patients with a mean ± SE age of 71 ± 2 years (range, 40-86) had disabling claudication (less than 100 meters) for more than 5 months while 11% reported pain at rest. A 6-week water intake of more than 2,500 mL/24 hr was achieved in 35 of the 36 patients enrolled in the study. Increased water intake was associated with significant improvements in median ankle/brachial index (from 0.60 to 0.76; P < 0.0001) and skin temperature (first dorsal right toe, from 29.95°C to 30.0°C, P < 0.001). Time and distance to report claudication of supervised treadmill exercise improved from 1.25 to 6.25 min (P < 0.0001) and from 100 meters to 535 meters (P < 0.0001), respectively. CONCLUSIONS This study suggests that hydration attained by daily water consumption of more than 2.5 L has a robust impact on reducing the symptoms of disabling claudication and rest pain caused by peripheral vascular disease.
-
10.
What fluids are given during air ambulance treatment of patients with trauma in the UK, and what might this mean for the future? Results from the RESCUER observational cohort study.
Naumann, DN, Hancox, JM, Raitt, J, Smith, IM, Crombie, N, Doughty, H, Perkins, GD, Midwinter, MJ, ,
BMJ open. 2018;(1):e019627
Abstract
OBJECTIVES We investigated how often intravenous fluids have been delivered during physician-led prehospital treatment of patients with hypotensive trauma in the UK and which fluids were given. These data were used to estimate the potential national requirement for prehospital blood products (PHBP) if evidence from ongoing trials were to report clinical superiority. SETTING The Regional Exploration of Standard Care during Evacuation Resuscitation (RESCUER) retrospective observational study was a collaboration between 11 UK air ambulance services. Each was invited to provide up to 5 years of data and total number of taskings during the same period. PARTICIPANTS Patients with hypotensive trauma (systolic blood pressure <90 mm Hg or absent radial pulse) attended by a doctor. PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcome was the number of patients with hypotensive trauma given prehospital fluids. Secondary outcomes were types and volumes of fluids. These data were combined with published data to estimate potential national eligibility for PHBP. RESULTS Of 29 037 taskings, 729 (2.5%) were for patients with hypotensive trauma attended by a physician. Half were aged 21-50 years; 73.4% were male. A total of 537 out of 729 (73.7%) were given fluids. Five hundred and ten patients were given a single type of fluid; 27 received >1 type. The most common fluid was 0.9% saline, given to 486/537 (90.5%) of patients who received fluids, at a median volume of 750 (IQR 300-1500) mL. Three per cent of patients received PHBP. Estimated projections for patients eligible for PHBP at these 11 services and in the whole UK were 313 and 794 patients per year, respectively. CONCLUSIONS One in 40 air ambulance taskings were manned by physicians to retrievepatients with hypotensive trauma. The most common fluid delivered was 0.9% saline. If evidence justifies universal provision of PHBP, approximately 800 patients/year would be eligible in the UK, based on our data combined with others published. Prospective investigations are required to confirm or adjust these estimations.