A randomized, controlled trial of albumin versus saline for the treatment of intradialytic hypotension. A prospective randomized trial evaluating colloid versus crystalloid resuscitation in the treatment of the vascular leak syndrome associated with interleukin-2 therapy. A prospective analysis of hypertonic lactated saline v. Ringer's lactate-colloid for the resuscitation of severely burned children. Randomized trial of volume expansion with albumin or saline in children with severe malaria: preliminary evidence of albumin benefit. Randomised controlled trial of colloid or crystalloid in hypotensive preterm infants. Randomized trial of normal saline versus 5% albumin for the treatment of neonatal hypotension. Replacement of major surgical blood loss by hypo-oncotic or conventional plasma substitutes. Randomised controlled trial of colloid infusions in hypotensive preterm infants. [Comparison of 5% human albumin and 6% 200/0.5 HES as exclusive colloid components in large surgical interventions].
Intradialytic hypotension (IDH) is the most common complication of hemodialysis. Symptomatic IDH requires the administration of fluid and often results in the early termination of dialysis, both of which may prevent adequate fluid removal. The optimal fluid for the treatment of IDH remains unknown. A randomized, double-blind, crossover trial was performed in 72 chronic hemodialysis patients to determine whether 5% albumin was more effective than normal saline for the treatment of IDH. The primary outcome measure was the percentage of target ultrafiltration achieved, which was defined as the actual ultrafiltration volume divided by target ultrafiltration volume. Secondary outcome measures included postdialysis BP, time to restore BP, recurrent IDH, and treatment failure (inability to restore BP with 750 ml of study fluid). The percentage of target ultrafiltration achieved was 0.84 +/- 0.17 for 5% albumin compared with 0.80 +/- 0.16 for saline (P = 0.14). The postdialysis systolic BP (121 +/- 19 mmHg versus 117 +/- 19 mmHg; P = 0.32), postdialysis diastolic BP (63 +/- 9 mmHg versus 61 +/- 9 mmHg; P = 0.33), volume of study fluid used to treat IDH (403 +/- 170 ml versus 428 +/- 191 ml; P = 0.34), time required to restore the BP (7.9 +/- 6.6 min versus 9.9 +/- 7.5 min; P = 0.09), total nursing time required to manage the hypotensive episode (15.1 +/- 7.2 min versus 15.9 +/- 7.3 min; P = 0.47), number of treatment failures (22% versus 24%; P = 1.0), and the frequency of recurrent IDH (36% versus 36%) were not significantly different when 5% albumin was used compared with saline. It is concluded that 5% albumin is no more effective than normal saline for the treatment of IDH in chronic hemodialysis patients. Normal saline should be used as the initial fluid for the treatment of IDH. Interleukin-2 (IL-2)-based therapy induces a vascular leak syndrome (VLS), manifested by hypotension, tachycardia, and oliguria, as is also seen with septic shock. The optimal method for treating such VLS is not known. A prospective randomized trial was undertaken to compare crystalloid and colloid fluid resuscitation for patients receiving bolus IL-2-based therapy for metastatic cancer. All patients received maintenance crystalloid fluid administration and were randomized to receive crystalloid (0.9% normal saline) or colloid (5% human serum albumin) fluid boluses to maintain acceptable vital signs and urine output. Patients refractory to fluid boluses were given dopamine for oliguria and/or phenylephrine for hypotension. Of 107 patients who completed one cycle of therapy on study, 76 completed a full treatment course (two cycles) on study. The total number of saline and albumin fluid boluses given were 9.5 +/- 0.9 versus 7.7 +/- 0.7 (p = 0.36, n = 107) for the first cycle and 19.2 +/- 1.8 versus 16.1 +/- 1.6 (p = 0.33, n = 76) for a complete course, respectively. Although patients receiving saline boluses had significantly more oliguria during a course of therapy, weight gain, number of IL-2 doses, tachycardia, hypotension, vasopressor use, hospital stay, and clinical response rates did not significantly differ between arms. Changes in hematocrit, hemoglobin, protein, albumin, blood urea nitrogen (BUN), and creatinine were analyzed, and patients receiving crystalloid showed greater decreases in albumin (p < 0.0001) and total protein (p < 0.05) as expected. A 40-fold greater cost associated with albumin suggested that crystalloid resuscitation be used to treat the VLS associated with IL-2 therapy.(ABSTRACT TRUNCATED AT 250 WORDS) Children and young people ranging in age from 5 months to 21 years, with burns covering greater than or equal to 30 per cent of the body surface area, were entered into a prospective study comparing the resuscitative efficacy of hypertonic lactated saline (HLS) and Ringer's lactate-colloid (RL-colloid). The 24- and 48-h fluid requirements of children resuscitated with the RL-colloid were significantly greater than those resuscitated with HLS (P less than 0.02); 2.37 +/- 0.91 ml/kg/per cent burn (HLS) v. 3.43 +/- 1.51 ml/kg/per cent burn (RL-colloid) at 24 h post-burn and 4.18 +/- 1.37 ml/kg/per cent burn (HLS) v. 6.32 +/- ml/kg/per cent burn (RL-colloid) at 48 h (P less than 0.01). The urine output between the two groups was not significantly different, and the haematocrits were equally maintained. Patients in the RL-colloid group gained significantly more weight at 48 h (P less than 0.05). The sodium requirements and resulting sodium balances were not significantly different. The desired and significant elevation (P less than 0.001) of serum sodium in the HLS group was maintained for the 5 days of the study. Colloid oncotic pressures, serum albumin and albumin/globulin (A/G) ratios were not significantly different between the two groups until 48 h post-burn. The RL-colloid group received plasmanate during the second 24-h period. The significant elevation in serum albumin, A/G ratio and colloid oncotic pressure persisted for only 2 days--by 96 h post-burn these values were no longer significantly different.(ABSTRACT TRUNCATED AT 250 WORDS) Metabolic acidosis is the best predictor of death in children with severe falciparum malaria; however, its treatment presents a therapeutic dilemma, because acidosis and hypovolemia may coexist with coma, which can be associated with elevated intracranial pressure. We postulated that volume resuscitation with albumin might correct acidosis and hypovolemia with a lower risk of precipitating cerebral edema than crystalloid. In an open-label, randomized, controlled trial, we compared the safety of resuscitation with albumin to saline in Kenyan children with severe malaria.
                We randomly assigned children with severe malaria and metabolic acidosis (base deficit, >8 mmol/L) to receive fluid resuscitation with either 4.5% albumin or normal saline. A control (maintenance only) group was only included for patients with a base deficit of <15 mmol/L. The primary outcome measure was the percentage reduction in base deficit at 8 h. Secondary end points included death, the requirement for rescue therapies, and neurological sequelae in survivors.
                Of 150 children recruited for the trial, 61 received saline, 56 received albumin, and 33 served as control subjects. There was no significant difference in the resolution of acidosis between the groups; however, the mortality rate was significantly lower among patients who received albumin (3.6% [2 of 56 patients]) than among those who received saline (18% [11 of 61]; relative risk, 5.5; 95% confidence interval, 1.2-24.8; P=.013).
                In high-risk children with severe malaria and acidosis, fluid resuscitation with albumin may reduce mortality. Our study design did not enable us to determine whether saline administration is preferable to fluid restriction or whether saline administration is actually hazardous. Further studies are needed to confirm our findings before definitive treatment recommendations can be made. To compare the efficacy of a colloid (5% albumin) and a crystalloid (isotonic saline) solution for treating hypotension in mechanically ventilated preterm infants.
                Sixty three preterm infants weighing 540 to 1950 g at birth and with gestational ages of 23 to 34 weeks, who developed hypotension (mean arterial pressure < 25, 30, and 35 mm Hg for infants with birthweight < 1, 1-1.49, and 1.5-1.99 kg, respectively) within the first 2 hours of life, were randomly allocated to receive intravenous infusions at 10 ml/kg of either 5% albumin (group 1, n = 32) or isotonic (0.9%) saline (group 2, n = 31). Inotropic support with dopamine infusion was given if the infants remained hypotensive after a total of three infusions (30 ml/kg). Subsequent extra doses of volume expander in the form of 5% albumin was given, depending on the infant's blood pressure.
                There was no difference in the volume of the test solutions required between the two groups. Outcome, as assessed by the number of infants requiring inotropic support and death or chronic lung disease, did not differ between the groups. After inotropic support, however, group 1 required significantly more volume expander to maintain normal blood pressure (median: 27.5 ml/kg vs 10 ml/kg; P = 0.0187) and had a higher mean (SEM) percentage weight gain within the first 48 hours of life (at 24 hours: 6.3(1.3)% vs 3.3(0.8)%; P = 0.049; at 48 hours: 5.9(1.9)% vs 0.9(1.7)%; P = 0.045). The difference in weight gain was significant at 48 hours even when only those infants not requiring inotropic support or extra 5% albumin were compared (group 1: 1.5(1.5)%, group 2: -4.2(1.1)%; P = 0.027).
                Isotonic saline is as effective as 5% albumin for treating hypotension in preterm infants, and it has the additional advantage of causing less fluid retention in the first 48 hours. This study was designed to assess the comparative efficacy of normal saline (NS) and 5% albumin (ALB) for treatment of hypotension in the acutely ill newborn.
                Newborn infants who were < 24 hours old and were admitted to the Holden Neonatal Intensive Care Unit at the University of Michigan were randomized to receive one of the two solutions for volume expansion. Hypotension was defined as a sustained (> or =30 minutes) mean arterial pressure (MAP) of < 30 mmHg for infants weighing < or =2500 g, or a MAP of < 40 mmHg for those weighing > 2500 g. The short-term outcome measure was the resolution of hypotension defined as a MAP over the minimum limits set for birthweight sustained for > or =30 minutes.
                In total 41 infants met criteria and were entered. Of these, 21 infants received ALB and 20 received NS. Successful treatment was seen in 17/21 (81%) of infants in the ALB group and 17/20 (85%) of infants in the NS group. There was no statistically significant difference in response to treatment (p=0.30). In addition, there was no statistically significant difference in the magnitude of change in MAP between the two (p=0.41).
                NS was shown to be as effective as ALB for the correction of acute hypotension in the newborn infant. Given comparable efficacy of NS, along with its relatively low cost and availability, it should be considered the initial treatment of choice in this setting. The purpose of the study was to examine the effects of hypooncotic 4% hydroxyethyl starch 120/0.7, 3% dextran 70, 5% albumin and hyperoncotic 6% hydroxyethyl starch 120/0.7 on the perioperative colloid osmotic pressure (COP), albumin and protein concentrations and fluid balance. The plasma substitutes were used with red cell concentrates to replace blood loss with equal volume in sixty major abdominal or urological surgeries. A special effort was made to keep replacements and losses at even volumes constantly and to avoid fluctuation of blood volume. The blood specimen were obtained before induction, after each 20% blood loss, at the end of the recovery room phase and on the three following postoperative mornings. There were significant differences in the peroperative and immediate postoperative COPs. However, these differences had vanished by the first postoperative morning. COP was preserved above 16 mmHg in all groups throughout the study. The identical peroperative albumin and protein concentrations of the synthetic colloid groups suggests that their volume effect was the same, regardless of the varying COP. During the observation period there were no significant differences among the groups concerning the diuresis and the fluid balances. We conclude, that the hypooncotic 4% HES 120 and 3% dextran 70 solutions provide the same clinical effect as 6% HES 120 solution. Consequently less colloid is needed, which allows the use of greater volumes of the dilute colloid solutions in replacement therapy. Colloid infusions are often given to treat hypotension in preterm infants. The aim of this work was to assess whether it was the amount of protein or the volume of the colloid infused which accounted for the observed increase in blood pressure. Sixty preterm infants were randomised (20 in each group) to receive 5 ml/kg 20% albumin, 15 ml/kg fresh frozen plasma, or 15 ml/kg 4.5% albumin. All infusions were given at a rate of 5 ml/kg/hour in addition to maintenance fluids. The infants were randomised when hypotensive (systolic blood pressure less than 40 mm Hg for two hours). There was no significant difference in the blood pressure of the three groups before or one hour after beginning the infusion. The mean increase in blood pressure one hour after completing the infusion, however, was significantly lower in infants receiving 20% albumin: 9% compared with 17% in the group receiving 4.5% albumin, and 19% in the group receiving fresh frozen plasma. It is concluded that the volume infused rather than albumin load is important in producing a sustained increase in blood pressure. It was the purpose of the following study to compare effects of 6% hydroxyethyl starch 200/0.5 (HES) and albumin 5% (HA5) on haemostasis, haemodynamics, oncotic function and plasmatic homoeostasis.
                In 2 randomised groups of 20 patients each undergoing large surgery (criteria of exclusion: anaemia, renal, liver, and coagulation disorders, ASA classification > III) we treated up to 1000 ml with colloid solution, from 1000 ml up to 5000 ml with packed red blood cells (PRBC) and colloid solution (1:1) and above 5000 ml with PRBC and fresh frozen plasma (1:1). Group HES received HES and group HA5 albumin as exclusive colloid component and both continuously lactated Ringers' at a rate of 500 ml/h. We measured the parameters before operation, after each 1000 ml colloid up to 3000 ml application and at the end of operation and we registered total blood output/intake.
                We found comparable amounts of blood loss and blood intake (mean total amount of colloid solution: HES 2044 +/- 579 ml; HA5 2547 +/- 980 ml). We didn't find any differences in haemodynamics nor in haematocrit, platelets or global coagulation parameters which only showed dilutional influences. Differences existed in total serum protein (HES 32.8 +/- 6.5 gr/l; HA5 54 +/- 5.5 gr/l at OP's end); however COP was maintained in both groups during the whole study period at normal ranges. Plasmatic haemostasis showed to a large extent corresponding values. Remarkable was the development of a metabolic acidosis in the HA5 group.
                Regarding total blood output/intake, haemodynamic functions, haematological parameters, coagulation, oncotic function, and plasmatic homoeostasis, HES is a safe colloid if contra-indications are taken into account, capable of replacing albumin 5% entirely as a colloid component of treatment of even large blood losses intraoperatively above the recommended dose of 20 ml/kg BW/d.
No randomised or controlled trial was identified comparing albumin to crystalloids (other than normal saline) or non-protein colloids, or a combination of both, in the treatment of symptomatic hypotension during dialysis. One double blind crossover RCT in 45 assessable patients showed that 5% albumin is not superior to normal saline for the treatment of symptomatic hypotension in maintenance haemodialysis patients with a previous history of IDH. Given the cost and relative rarity of albumin use compared to saline, saline should be first line of therapy for treatment of IDH in stable dialysis patients.