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Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial
Jardot, F., Hahn, R. G., Engel, D., Beilstein, C. M., Wuethrich, P. Y.
Critical care (London, England). 2024;28(1):39
Abstract
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.
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Effects of balanced hydroxyethyl starch 6% (130/0.4) and albumin 5% on clot formation and glycocalyx shedding: Subgroup analysis of a prospective randomized trial
Kammerer T, Hulde N, Speck E, Hubner M, Crispin A, Zwissler B, Conzen P, von Dossow V, Schafer ST, Hofmann-Kiefer K, et al
Thrombosis research. 2019;183:111-118
Abstract
BACKGROUND Intravenous fluids can impair coagulation and affect the endothelial glycocalyx, whereas glycocalyx shedding itself can cause an impairment of clot formation and firmness. We hypothesized that hydroxyethyl starch 6% (130/0.4) has a more distinct effect on coagulation and glycocalyx shedding than albumin 5%. METHODS Presented data derive from an exploratory subgroup analysis of a prospective randomized, single-blinded trial comparing albumin 5% versus balanced hydroxyethyl starch 6% (130/0.4). Patients between 46 and 85years undergoing cystectomy were included. Prothrombin time, plasma fibrinogen concentration, partial thromboplastin time, thrombelastometry and platelet function were analyzed before and after surgery. Glycocalyx components were assessed before and after surgery, 2 to 4h after surgery and at 1st and 3rd postoperative day. Primary outcome parameter was the change of thrombelastometric variables at the end of surgery. Further variables included calculated blood loss, infusion amount and transfusion rate. RESULTS 55 patients (albumin group n=28; hydroxyethyl starch group n=27) were included. Thrombelastometric variables were significantly more compromised in the hydroxyethyl starch than in the albumin group whereas platelet function, glycocalyx shedding, partial thromboplastin time, prothrombin time and fibrinogen were not different between groups. Mean intraoperative calculated blood loss was higher in the hydroxyethyl starch group (1557+/-825ml versus 1245+/-709ml; p=0.042). Transfusion requirements did not differ. CONCLUSION Rotational thrombelastometric variables were significantly more reduced when hydroxyethyl starch was used compared to albumin 5%. This effect was independent from a shedding of the endothelial glycocalyx. However, results presented here are from a subgroup analysis and must be considered with caution. Trial registration EudraCT number 2010-018343-34.
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No differences in renal function between balanced 6% hydroxyethyl starch (130/0.4) and 5% albumin for volume replacement therapy in patients undergoing cystectomy: a randomized controlled trial
Kammerer T, Brettner F, Hilferink S, Hulde N, Klug F, Pagel J, Karl A, Crispin A, Hofmann-Kiefer K, Conzen P, et al
Anesthesiology. 2017;128((1):):67-78
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Abstract
BACKGROUND The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6% (130/0.4) on renal function and kidney injury. METHODS One-hundred urologic patients undergoing elective cystectomy were randomly assigned for this prospective, single-blinded, controlled study with two parallel groups to receive either albumin 5% or balanced hydroxyethyl starch 6% (130/0.4) as the only perioperative colloid. The primary endpoint was the ratio of serum cystatin C between the last visit at day 90 and the first preoperative visit. Secondary endpoints were estimated glomerular filtration rate and serum neutrophil gelatinase-associated lipocalin until the third postoperative day and risk, injury, failure, loss, and end-stage renal disease criteria at postoperative days 3 and 90. RESULTS The median cystatin C ratio was 1.11 (interquartile range, 1.01 to 1.23) in the albumin and 1.08 (interquartile range, 1.00 to 1.20) in the hydroxyethyl starch group (median difference = 0.03; 95% CI, -0.09 to 0.08; P = 0.165). Also, there were no significant differences concerning serum cystatin C concentrations; estimated glomerular filtration rate; risk, injury, failure, loss, and end stage renal disease criteria; and neutrophil gelatinase-associated lipocalin. Infusion requirements, transfusion rates, and perioperative hemodynamics were similar in both groups. CONCLUSIONS With respect to renal function and kidney injury, this study indicates that albumin 5% and balanced hydroxyethyl starch 6% have comparable safety profiles in noncritically ill patients undergoing major surgery.
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Impact of albumin on coagulation competence and hemorrhage during major surgery: a randomized controlled trial
Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH
Medicine. 2016;95((9)):e2720.
Abstract
For patients exposed to a massive blood loss during surgery, maintained coagulation competence is important. It is less obvious whether coagulation competence influences bleeding during elective surgery where patients are exposed to infusion of a crystalloid or a colloid.This randomized controlled trial evaluates whether administration of 5% human albumin (HA) or lactated Ringer solution (LR) affects coagulation competence and in turn blood loss during cystectomy due to bladder cancer.Forty patients undergoing radical cystectomy were included to receive either 5% HA (n = 20) or LR (n = 20). Nineteen patients were analyzed in the HA group and 20 patients in the lactated Ringer group.Blinded determination of the blood loss was similar in the 2 groups of patients: 1658 (800-3300) mL with the use of HA and 1472 (700-4330) mL in the lactated Ringer group (P = 0.45). Yet, by thrombelastography (TEG) evaluated coagulation competence, albumin affected clot growth (TEG-angle 69 +/- 5 vs 74 degrees +/- 3 degrees , P < 0.01) and strength (TEG-MA: 59 +/- 6 vs 67 +/- 6 mm, P < 0.001) more than LR. Furthermore, by multivariate linear regression analyses reduced TEG-MA was independently associated with the blood loss (P = 0.042) while administration of albumin was related to the changes in TEG-MA (P = 0.029), aPPT (P < 0.022), and INR (P < 0.033).This randomized controlled trial demonstrates that administration of HA does not affect the blood loss as compared to infusion of LR. Also the use of HA did not affect the need for blood transfusion, the incidence of postoperative complications, or the hospital in-stay. Yet, albumin decreases coagulation competence during major surgery and the blood loss is related to TEG-MA rather than to plasma coagulation variables.
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Peri-operative tolerance to large-dose 6% HES 200/0.5 in major urological procedures compared with 5% human albumin
Vogt N, Bothner U, Brinkmann A, de Petriconi R, Georgieff M
Anaesthesia. 1999;54((2):):121-7.
Abstract
We studied the long-term efficacy and safety of medium-molecular-weight hydroxyethyl starch (HES) administered in doses above 20 ml.kg-1 during major blood replacement therapy. Blood replacement for 50 patients used 6% HES 200/0.5 (HES group) or 5% albumin (ALB group) and additional blood components according to a defined protocol. We compared safety, efficacy and costs in 4 peri-operative days. Colloid administration on the day of surgery was 38.4 ml.kg-1 (HES group) and 35.1 ml.kg-1 (ALB group). Haemodynamic, coagulation and renal function parameters were similar. Although total serum protein was still different on the third postoperative day (53.45 gl-1 (HES group) and 60.6 gl-1 (ALB group) (p < 0.01)) the colloid osmotic pressure always remained above 19.5 (2.5) mmHg (HES group). Blood loss (3810 (1632) ml (HES group) and 3455 (1733) ml (ALB group)) and the requirement for blood components was comparable. Costs were reduced by 35% (p < 0.05) in the HES group. We conclude that using 6% HES 200/0.5 as the only colloid for treatment even of large blood loss is a safe and economic alternative to albumin.