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Effect of Hydroxyethyl starch (HES) versus 5% albumin solution on intra-abdominal pressure in severe burn patients: A prospective randomized clinical trial
Abdelmotaal, A. M., Abdelsalam, A. M., Bakry, S. A. D., Abdel Hafiez, R. H., Mabrouk, A. R.
Burns : journal of the International Society for Burn Injuries. 2023
Abstract
INTRODUCTION Massive burn patients are at risk of developing intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) as a complication of resuscitation. OBJECTIVE This study aimed to evaluate the effect of Hydroxyethyl starch (HES) versus 5% albumin solution on intra-abdominal pressure (IAP) in massive burn patients. METHODS This was a prospective randomized clinical trial carried on at Ain Shams University (ASU) burn unit for 2 years. Where adult patients with burns more than 20% of TBSA were equally randomized into HES group or albumin group. RESULTS Fifty-two patients were equally randomized into 2 groups. We found no difference in age, sex, weight, type of burn, and TBSA between the two groups. The mean total resuscitation fluid volume in the first 48 h was 213 ml/kg and 206.2 ml/kg for the HES group and the albumin group respectively (p = 0.674). IAP statistically was non-significantly higher in the HES group. We found no statistical difference between the two groups as regards the renal function tests. CONCLUSION Both HES and 5% albumin solution are effective and safe colloids for burn resuscitation. As regards the IAP, it seems that both 5% albumin and HES have comparable effect regarding IAH in severely burn patients. Both HES and 5% albumin were partially equal in terms of renal involvement and vital data stability.
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Different Concentrations of Albumin Versus Crystalloid in Patients with Sepsis and Septic Shock: A Meta-Analysis of Randomized Clinical Trials
Geng L, Tian X, Gao Z, Mao A, Feng L, He C
Journal of intensive care medicine. 2023;:8850666231170778
Abstract
OBJECTIVE The best type of resuscitation fluids for sepsis and septic shock patients remains unclear. The aim of this study was to evaluate the efficacy of different concentrations of albumin on reducing the mortality rate of theses patients by meta-analysis. MATERIALS AND METHODS PubMed, EMBASE, and Web of Science databases were used for screening the relevant studies. Randomized controlled trials (RCTs) were eligible if they compared the effects of albumin with crystalloid on mortality in patients with sepsis and septic shock. Data were examined and extracted by two reviewers independently. Any disagreements were resolved by consensus with or without the help from a third reviewer. Data including mortality, sample size of the patients, and resuscitation endpoints were extracted. Meta-analysis was carried based on the corresponding odds ratios with 95% confidence intervals. RESULTS Eight studies with a total of 5124 septic patients and 3482 septic shock patients were included in this study. Compared with crystalloid, the use of albumin may represent a trend toward reduced the 90-day mortality of septic patients (OR 0.91 [0.80, 1.02]; P = .11) and significantly improved the outcome of septic shock patients (OR 0.85 [0.74, 0.99]; P = .04). Further analysis showed a potentially beneficial role of both 4% to 5% and 20% albumin on reducing the mortality of septic patients. The use of 20% albumin significantly decreased the 90-day mortality of septic shock patients (OR 0.81 [0.67, 0.98]; P = .03), which was better than 4% to 5% albumin and crystalloid. CONCLUSIONS Albumin treatment, particularly 20% albumin, significantly reduced the 90-day mortality in septic shock patients. Both 4% to 5% and 20% of albumin may work better than crystalloid in improving the survival rate of patients with sepsis, but more relative RCTs are required for validation.
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Efficacy of albumin with diuretics in mechanically ventilated patients with hypoalbuminemia: A systematic review and meta-analysis
Itagaki, Y., Yoshida, N., Banno, M., Momosaki, R., Yamada, K., Hayakawa, M.
Medicine. 2022;101(37):e30276
Abstract
BACKGROUND Hypoalbuminemia is associated with fluid overload, the development of acute respiratory distress syndrome, and mortality. The co-administration of albumin and diuretics for the treatment of patients with hypoalbuminemia is expected to increase urine output, without hemodynamic instability, and improve pulmonary function; however, these effects have not been systematically investigated. Here, we aimed to clarify the benefits of the co-administration of albumin and diuretics in mechanically ventilated patients. METHODS We searched for randomized, placebo-controlled trials that investigated the effects of the co-administration of albumin and diuretics compared with placebo and diuretics, in mechanically ventilated patients with hypoalbuminemia. We searched these trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via PubMed, and EMBASE databases. Primary outcomes were hypotensive events after the intervention, all-cause mortality, and the length of mechanical ventilation. Secondary outcomes were improvement in the ratio of partial pressure arterial oxygen and fraction of inspired oxygen (P/F ratio) at 24 hours, total urine output (mL/d), and the clinical requirement of renal replacement therapy (RRT). RESULTS From the 1574 records identified, we selected 3 studies for quantitative analysis. The results of albumin administration were as follows: hypotensive events (risk ratio [RR] -1.05 [95% confidence interval {CI}: 0.15-0.81]), all-cause mortality (RR 1.0 [95% CI: 0.45-2.23]), the length of mechanical ventilation in days (mean difference -1.05 [95% CI: -3.35 to 1.26]), and improvement in P/F ratio (RR 2.83 [95% CI: 1.42-5.67]). None of the randomized controlled trials reported the total urine output, and one reported that no participants required RRT. Adverse events were not reported during the trials. The certainty of evidence was low (in the hypotensive events after the intervention and all-cause mortality) to moderate (in the length of mechanical ventilation in days, improvement of P/F ratio, clinical requirement of RRT, and adverse events). CONCLUSIONS Although this treatment combination reduced the number of days for which mechanical ventilation was required, it did not reduce the all-cause mortality at 30 days. In conclusion, the co-administration of albumin and diuretics may reduce hypotensive events and improve the P/F ratio at 24 hours.
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Effects of Albumin Supplements on In-Hospital Mortality in Patients with Sepsis or Septic Shock: A Systemic Review and Meta-Analysis
Liu P, Zhi D, Wang Y, Lin J, Zhang M, Duan M
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:2384730
Abstract
OBJECTIVE To explore the clinical effects of albumin supplements on the basis of crystalloid solution in patients with sepsis or septic shock. METHODS The online databases including PubMed, Web of Science, Cochrane Library, and EMBASE were comprehensively searched from inception to June 28, 2021, with the keywords including "albumin," "sepsis," or "septic shock." Retrospective cohort (RC) and randomized controlled trials (RCT) were included for analysis. Two authors independently searched and analyzed the literature. The in-hospital mortality at 7 days and 28 days, duration of mechanical ventilation, renal replacement therapy, length of ICU stay, and length of hospital stay were compared between patients with albumin supplements and crystalloid solution and those with crystalloid alone. RESULTS A total of 10 studies with 6463 patients were eventually included for meta-analysis. The in-hospital mortality of patients at 7 days (OR = 1.00, 95% CI: 0.81-1.23) and 28 days (OR = 1.02, 95% CI: 0.91-1.13) did not show a significant difference between the two groups of patients. Also, the pooled results demonstrated no significant differences in duration of mechanical ventilation (OR = 0.29, 95% CI: -0.05-0.63), renal replacement therapy (WMD = 1.15, 95% CI: 0.98-1.35), length of ICU stay (WMD = -0.07, 95% CI: -0.62-0.48), and length of hospital stay (WMD = -0.09, 95% CI: -0.70-0.52) between patients receiving albumin plus crystalloid solution and those with crystalloid solution alone. CONCLUSION Albumin supplements on the basis of crystalloid solution did not improve the 7-day and 28-dayin-hospital mortality in patients with sepsis or septic shock compared with those with crystalloid solution alone.
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Adsorption of insulin onto neonatal infusion sets: should intravenous administration of insulin to treat hyperglycemia in preterm babies on the NICU be proceeded by priming of the intravenous system, adding of albumin, or non-priming to get to a stable insulin dose?
Mian P, Bolhuis MS, Maurer JM, van Stuijvenberg M
Molecular and cellular pediatrics. 2022;9(1):20
Abstract
Insulin is used to treat neonatal hyperglycaemia when blood glucose concentrations are consistently high, and to treat neonatal diabetes. Within this brief report, a review of the existing literature is conducted to determine if intravenous administration of insulin should be proceeded by priming of the intravenous system, adding of albumin, or non-priming to get a stable insulin dose. Within this literature search, we focused on experimental insulin adsorption data (in vitro studies).
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A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]
Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK
Journal of hepatology. 2022
Abstract
BACKGROUND AND AIM The choice of resuscitation fluid in cirrhosis patients with sepsis-induced hypotension (SIH) is unclear. 5% albumin has been superior to normal saline in the FRISC study. We compared the efficacy and safety of 20% albumin, which has greater oncotic properties with plasmalyte in reversing SIH. METHODS Critically-ill cirrhosis(CIC) patients underwent open-label randomization to receive either 20% albumin [0.5-1.0gm/kg over 3 hours; n=50] or plasmalyte (30ml/kg over 3 hours, n=50). The primary end-point of the study was the attainment of mean arterial pressure (MAP) above 65 mmHg at three hours. RESULTS Baseline characteristics were comparable in albumin and plasmalyte groups; arterial lactate(mmol/L) [6.16±3.18 vs. 6.38±4.77; p=0.78), MAP (mmHg) [51.4±6.52 vs. 49.9±4.45; p=0.17] and SOFA score [10.8±2.96 vs. 11.1±4.2; p=0.68] respectively. Most patients were alcoholics (39%) and had pneumonia (40%). In the intention-to-treat (ITT) analysis, albumin was superior to plasmalyte in achieving the primary end-point (62% vs. 22%; p<0.001). A rapid decline in arterial lactate (P=0.03), a lesser proportion of dialysis [48% vs. 62%; p=0.16], and a higher time to initiation of dialysis (in hours) [68.13±47.79 vs. 99.7± 63.4; p=0.06] was seen with albumin. However, the 28-day mortality was not different (58% vs. 62%, p=0.57). Patients in the albumin group required discontinuation of therapy in 11 (22%) patients due to adverse effects compared to none in plasmalyte group. CONCLUSION In patients with cirrhosis and SIH, 20% albumin transiently improves the hemodynamics with early lactate clearance than plasmalyte but needs monitoring as it is more often attended with pulmonary complications. Both fluids provide comparable 28 days survival. NCT02721238 LAY SUMMARY The current randomized controlled trial performed in critically ill patients with cirrhosis and sepsis-induced hypotension highlights that 20% albumin restores hemodynamics but causes more pulmonary complications than plasmalyte. The impact on renal functions was also modest. These effects did not result in improvement in deaths at 28-days. Plasmalyte is safer and well-tolerated and can be considered for volume resuscitation in patients with cirrhosis and sepsis-induced hypotension.
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Intravenous albumin for the prevention of hemodynamic instability during sustained low-efficiency dialysis: a randomized controlled feasibility trial (The SAFER-SLED Study)
Clark EG, McIntyre L, Watpool I, Kong JWY, Ramsay T, Sabri E, Canney M, Hundemer GL, Brown PA, Sood MM, et al
Annals of intensive care. 2021;11(1):174
Abstract
BACKGROUND Hemodynamic instability is a frequent complication of sustained low-efficiency dialysis (SLED) treatments in the ICU. Intravenous hyperoncotic albumin may prevent hypotension and facilitate ultrafiltration. In this feasibility trial, we sought to determine if a future trial, powered to evaluate clinically relevant outcomes, is feasible. METHODS This single-center, blinded, placebo-controlled, randomized feasibility trial included patients with acute kidney injury who started SLED in the ICU. Patients were randomized to receive 25% albumin versus 0.9% saline (control) as 100 mL boluses at the start and midway through SLED, for up to 10 sessions. The recruitment rate and other feasibility outcomes were determined. Secondary exploratory outcomes included ultrafiltration volumes and metrics of hemodynamic instability. RESULTS Sixty patients (271 SLED sessions) were recruited over 10 months. Age and severity of illness were similar between study groups. Most had septic shock and required vasopressor support at baseline. Protocol adherence occurred for 244 sessions (90%); no patients were lost to follow-up; no study-related adverse events were observed; open label albumin use was 9% and 15% in the albumin and saline arms, respectively. Ultrafiltration volumes were not significantly different. Compared to the saline group, the albumin group experienced less hemodynamic instability across all definitions assessed including a smaller absolute decrease in systolic blood pressure (mean difference 10.0 mmHg, 95% confidence interval 5.2-14.8); however, there were significant baseline differences in the groups with respect to vasopressor use prior to SLED sessions (80% vs 61% for albumin and saline groups, respectively). CONCLUSIONS The efficacy of using hyperoncotic albumin to prevent hemodynamic instability in critically ill patients receiving SLED remains unclear. A larger trial to evaluate its impact in this setting, including evaluating clinically relevant outcomes, is feasible. Trial registration ClinicalTrials.gov (NCT03665311); First Posted: Sept 11th, 2018. https://clinicaltrials.gov/ct2/show/NCT03665311?term=NCT03665311&draw=2&rank=1.
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Albumin replacement therapy in immunocompromised patients with sepsis - Secondary analysis of the ALBIOS trial
Cortegiani A, Grasselli G, Meessen J, Moscarelli A, Ippolito M, Turvani F, Bonenti CM, Romagnoli S, Volta CA, Bellani G, et al
Journal of critical care. 2021;63:83-91
Abstract
BACKGROUND The best fluid replacement strategy and the role of albumin in immunocompromised patients with sepsis is unclear. METHODS We performed a secondary analysis of immunocompromised patients enrolled in the ALBIOS trial which randomized patients with severe sepsis or septic shock to receive either 20% albumin (target 30 g per liter or more) and crystalloid or crystalloid alone during ICU stay. RESULTS Of 1818 patients originally enrolled, 304 (16.4%) were immunocompromised. One-hundred-thirty-nine (45.7%) patients were randomized in the albumin while 165 (54.2%) in the crystalloid group. At 90 days, 69 (49.6%) in the albumin group and 89 (53.9%) in the crystalloids group died (hazard ratio - HR - 0.94; 95% CI 0.69-1.29). No differences were observed with regards to 28-day mortality, SOFA score (and sub-scores), length of stay in the ICU and in the hospital, proportion of patients who had developed acute kidney injury or received renal replacement therapy, duration of mechanical ventilation. Albumin was not independently associated with a higher or lower 90-day mortality (HR 0.979, 95% CI 0.709-1.352) as compared to crystalloid. CONCLUSION Albumin replacement during the ICU stay, as compared with crystalloids alone, did not affect clinical outcomes in a cohort of immunocompromised patients with sepsis.
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Resuscitation fluid types in sepsis, surgical, and trauma patients: a systematic review and sequential network meta-analyses
Tseng CH, Chen TT, Wu MY, Chan MC, Shih MC, Tu YK
Critical care (London, England). 2020;24(1):693
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Editor's Choice
Abstract
BACKGROUND Crystalloids and different component colloids, used for volume resuscitation, are sometimes associated with various adverse effects. Clinical trial findings for such fluid types in different patients' conditions are conflicting. Whether the mortality benefit of balanced crystalloid than saline can be inferred from sepsis to other patient group is uncertain, and adverse effect profile is not comprehensive. This study aims to compare the survival benefits and adverse effects of seven fluid types with network meta-analysis in sepsis, surgical, trauma, and traumatic brain injury patients. METHODS Searched databases (PubMed, EMBASE, and Cochrane CENTRAL) and reference lists of relevant articles occurred from inception until January 2020. Studies on critically ill adults requiring fluid resuscitation were included. Intervention studies reported on balanced crystalloid, saline, iso-oncotic albumin, hyperoncotic albumin, low molecular weight hydroxyethyl starch (L-HES), high molecular weight HES, and gelatin. Network meta-analyses were conducted using random-effects model to calculate odds ratio (OR) and mean difference. Risk of Bias tool 2.0 was used to assess bias. Confidence in Network Meta-Analysis (CINeMA) web application was used to rate confidence in synthetic evidence. RESULTS Fifty-eight trials (n = 26,351 patients) were identified. Seven fluid types were evaluated. Among patients with sepsis and surgery, balanced crystalloids and albumin achieved better survival, fewer acute kidney injury, and smaller blood transfusion volumes than saline and L-HES. In those with sepsis, balanced crystalloids significantly reduced mortality more than saline (OR 0.84; 95% CI 0.74-0.95) and L-HES (OR 0.81; 95% CI 0.69-0.95) and reduced acute kidney injury more than L-HES (OR 0.80; 95% CI 0.65-0.99). However, they required the greatest resuscitation volume among all fluid types, especially in trauma patients. In patients with traumatic brain injury, saline and L-HES achieved lower mortality than albumin and balanced crystalloids; especially saline was significantly superior to iso-oncotic albumin (OR 0.55; 95% CI 0.35-0.87). CONCLUSIONS Our network meta-analysis found that balanced crystalloids and albumin decreased mortality more than L-HES and saline in sepsis patients; however, saline or L-HES was better than iso-oncotic albumin or balanced crystalloids in traumatic brain injury patients. TRIAL REGISTRATION PROSPERO website, registration number: CRD42018115641).
PICO Summary
Population
Sepsis, surgical, trauma, and traumatic brain injury patients (58 studies, n= 26,351).
Intervention
Systematic review and network meta-analysis to compare the survival benefits and adverse effects of seven fluid types.
Comparison
Balanced crystalloid, saline, iso-oncotic albumin, hyperoncotic albumin, low molecular weight hydroxyethyl starch (L-HES), high molecular weight HES, and gelatin.
Outcome
Among patients with sepsis and surgery, balanced crystalloids and albumin achieved better survival, fewer acute kidney injury, and smaller blood transfusion volumes than saline and L-HES. In those with sepsis, balanced crystalloids significantly reduced mortality more than saline and L-HES and reduced acute kidney injury more than L-HES. However, they required the greatest resuscitation volume among all fluid types, especially in trauma patients. In patients with traumatic brain injury, saline and L-HES achieved lower mortality than albumin and balanced crystalloids; especially saline was significantly superior to iso-oncotic albumin.
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Efficacy of furosemide-albumin compared with furosemide in critically ill hypoalbuminemia patients admitted to intensive care unit: a prospective randomized clinical trial
Mahmoodpoor A, Zahedi S, Pourakbar A, Hamishehkar H, Shadvar K, Asgharian P, Shahabi F, Hamishehkar H
Daru. 2020
Abstract
BACKGROUND Some physicians co-administer albumin with loop diuretics to overcome diuretic resistance in critically ill hypoalbuminemia patients, though previous studies have reported conflicting results on this matter. OBJECTIVE The effects of adding albumin to furosemide to enhance its efficacy in critically ill hypoalbuminemia patients are evaluated. METHODS This was a non-blinded randomized trial. 49 adult critically ill patients with hypoalbuminemia and generalized edema who received randomly furosemide and furosemide/albumin complex were enrolled. The patients' urine was collected at intervals of 2, 4, 6 and 8 h after initiation of the furosemide treatment, and the urine output and urinary excretion of furosemide and sodium were measured. The urinary excretion of furosemide was considered an indicator of drug efficacy. RESULTS The amount of sodium and furosemide excreted in urine showed no significant differences between the two groups; however, the mean of the urinary excretion of furosemide in the first 2 h after drug infusion was significantly higher (p = 0.03) in the furosemide/albumin group. No significant correlation between APACHE II scores and serum albumin levels and the urinary excretion of furosemide was seen. CONCLUSION The results indicated that there is not statistically significant differences between groups with furosemide alone and combined with albumin in urinary furosemide excretion. It seems that adding albumin for furosemide pharmacotherapy regime is not recommended as an intervention to increase furosemide efficacy in critically ill hypoalbuminemia patients. TRIAL REGISTRATION IRCT with the registration number IRCT201412132582N12 in 23 February 2015; https://en.irct.ir/trial/2356 Graphical abstract.
