Evaluation of the “Early” Use of Albumin in Children
with Extensive Burns: A Randomized Controlled Trial*
Maria Helena Müller Dittrich, MD1; Werther Brunow de Carvalho, MD, PhD2; Edson Lopes Lavado, PT, PhD3
Objective: To compare early versus delayed albumin resuscitation
in children with burns in terms of clinical outcome and response.
Design: Randomized controlled trial.
Setting: Burn center at a tertiary care teaching hospital.
Patients: Forty-six children aged 1–12 years with burns greater
than 15–45% total body surface area admitted within 12 hours
of burn injury.
Interventions: Fluid resuscitation was based on the Parkland for-
mula (3 mL/kg/% total body surface area), adjusted according to
urine output. Patients received 5% albumin solution between 8 and
12 hours post burn in the intervention group (n = 23) and 24 hours
post burn in the control group (n = 23). Both groups were assessed
for reduction in crystalloid fluid infusion during resuscitation, devel-
opment of fluid creep, and length of hospital stay.
Measurements and Main Results: There was no difference
between groups regarding age, weight, sex, % total body sur-
face area, cause of burn, or severity scores. The median crys-
talloid fluid volume required during the first 3 days post burn
was lower in the intervention than in the control group (2.04 vs
3.05 mL/kg/% total body surface area; p = 0.025 on day 1; 1.2
vs 1.71 mL/kg/% total body surface area; p = 0.002 on day 2;
and 0.82 vs 1.3 mL/kg/% total body surface area; p = 0.002 on
day 3). The median urine output showed no difference between
intervention and control groups (2.1 vs 2.0 mL/kg/hr; p = 0.152
*See also p. 578.
1
Burn Center, State University of Londrina, Londrina, Brazil.
2
Department of Pediatrics, Children’s Institute, University of São Paulo,
São Paulo, Brazil.
3
Department of Physical Therapy, State University of Londrina, Londrina,
Brazil.
Drs. Dittrich, de Carvalho, and Lavado contributed equally.
This study was performed at the Burn Center, University Hospital of
­Londrina, State University of Londrina, Londrina, PR, Brazil.
We agree to the terms of publication in this journal and are willing to
answer any questions or requests regarding this article.
The authors have disclosed that they do not have any potential conflicts
of interest.
Address requests for reprints to: Maria Helena Müller Dittrich, MD, Inten-
sive Care Unit of the Burn Center, State University of Londrina, Univer-
sity Hospital of Londrina, Avenida Robert Koch, 60 CEP 86038–350,
­Londrina, PR, Brazil. E-mail: mhdittrich@usp.br
Copyright © 2016 by the Society of Critical Care Medicine and the World
Federation of Pediatric Intensive and Critical Care Societies
DOI: 10.1097/PCC.0000000000000728
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on day 1; 2.58 vs 2.54 mL/kg/hr; p = 0.482 on day 2; and 2.9 vs
3.0 mL/kg/hr; p = 0.093 on day 3). Fluid creep was observed in
13 controls (56.5%) and in one patient (4.3%) in the intervention
group. The median length of hospital stay was 18 days (range,
15–21 d) for controls and 14 days (range, 10–17 d) in the inter-
vention group (p = 0.004).
Conclusions: Early albumin infusion in children with burns greater
than 15–45% total body surface area reduced the need for crys-
talloid fluid infusion during resuscitation. Significantly fewer cases
of fluid creep and shorter hospital stay were also observed in this
group of patients. (Pediatr Crit Care Med 2016; 17:e280–e286)
Key Words: albumins; burns; colloids; edema; pediatrics;
randomized controlled trial; resuscitation
R
ecent studies of burn injuries have demonstrated that
excessive administration of crystalloid and the aban-
donment of colloid replenishment at some point of
resuscitation are the major contributors to fluid overload, a
phenomenon termed “fluid creep” (1–3). This phenomenon
was first described by Pruitt (4) over a decade ago and is
characterized by insidious edema associated with major and
well-characterized systemic complications, including anasarca,
upper airway, and pulmonary edema requiring intubation,
pleural and pericardial effusions, wound deepening and edema
of the extremities requiring escharotomy or fasciotomy, need
for mechanical ventilation or prolonged ventilation in patients
without airway or facial burns, and increased intraocular pres-
sure that may lead to orbital compartment syndrome. Studies
have also reported increased risk of pneumonia, bloodstream
infection, acute respiratory distress syndrome, abdominal
compartment syndrome, multiple organ dysfunction syn-
drome, and death (1, 4–7).
Even the proper fluid resuscitation of burn shock may not
achieve complete normalization of physiologic variables in the
short term because the burn injury leads to ongoing cellular and
hormonal responses and total fluid resuscitation may extend
to 48–72 hours after the burn has occurred. One of the most
challenging aspects of caring for burn patients is to provide
adequate fluid resuscitation in order to maintain tissue perfu-
sion and prevent burn shock without causing overload, until a
gradual resolution of the physiological changes is observed (8).
June 2016 • Volume 17 • Number 6

Colloid administration in critically ill patients, including
extensively burned patients, was long believed to be associ-
ated with increased mortality. Historically, the prevailing view
was that the use of colloids was contraindicated during resus-
citation (9, 10). Later, some studies showed no difference in
mortality rates between colloid-resuscitated patients and those
who received crystalloid alone. The mortality of these patients
could not be attributed only to the use of colloid but rather to
a combination of factors and comorbidities (11, 12). Since the
recognition of fluid creep, several authors have reported on the
severity of its complications and proposed strategies to control
this phenomenon—and colloid administration is one of these
options (2, 5, 6).
Although the phenomenon of fluid creep has been observed
in the pediatric population, only few studies have investigated
the use of colloid for fluid resuscitation of pediatric burn
victims, and apparently the results are very similar to those
obtained in adults (2, 8, 13). The current trial was, therefore,
designed to compare, in children with extensive burns, early
versus delayed albumin use for resuscitation in terms of clini-
cal outcome and response.
In the current study, we tested the hypothesis that early
albumin infusion, administered 8–12 hours after burn injury,
would improve outcomes by reducing crystalloid fluid infu-
sion rates, fluid creep, and length of hospital stay in children
with extensive burns.
MATERIALS AND METHODS
Study Design
This was a randomized controlled trial in which children with
burns were randomly assigned in a 1:1 ratio to receive 5%
albumin solution between 8 and 12 hours or 24 hours post
burn. The study was conducted in accordance with the inter-
national ethical standards of the Declaration of Helsinki and
approved by the research ethics committee of the institution.
Written informed consent was obtained from the parents or
legal guardians of all individual participants included in the
study.
Participants
Participants were consecutively recruited among patients
receiving care in the burn center at a tertiary care teaching
hospital from June 2012 to January 2014. Eligible participants
were all children aged 1–12 years, of both sexes, who sustained
second- and third-degree burns greater than 15–45% total
body surface area (TBSA) and were admitted to the hospital
within 12 hours of the burn accident. This 12-hour time inter-
val between burn injury and hospital admission is considered
safe and able to minimize the impact of prehospital manage-
ment of burn injuries, i.e., to minimize a possible interference
of prehospital excessive or insufficient fluid infusion with the
patient’s clinical outcome (6, 14–16). All patients were evalu-
ated by a plastic surgeon, and TBSA was calculated according
to the Lund and Browder chart (17). Exclusion criteria were
comorbidities associated with liver disease, kidney disease, or
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heart disease, electrical burns or inhalation injury, and associ-
ated traumas.
Sample Size
Based on the results of previous studies indicating the occur-
rence of 1 million burn cases/yr and that 50% of patients with
severe burns develop fluid creep (1, 18), and assuming that the
occurrence of this phenomenon in the pediatric population is
similar to that of the adult population and that early albumin
infusion reduces the risk of fluid creep by 40%, we calculated
that a sample size of 23 patients per group was required to
detect a significant difference between the early and delayed
albumin resuscitation groups with a one-sided 5% significance
level, 90% power, and 95% CI.
Randomization
Participants were randomly assigned following a simple ran-
domization procedure (computerized random numbers) to
one of two treatment groups with a 1:1 allocation ratio. A
computer-generated randomization list was prepared by an
individual with no involvement in the trial for the allocation of
participants into two groups of 23 patients each. The allocation
sequence was concealed from the investigators enrolling and
assessing participants in sequentially numbered, opaque, and
sealed envelopes. Patients were included in the study sequen-
tially, and the corresponding envelopes were opened only after
the parents or legal guardians of the enrolled participant pro-
vided written informed consent.
Intervention
For initial fluid resuscitation, patients in the two groups
received IV lactated Ringer’s (LR) solution according to a
modified Parkland formula (3 mL × TBSA × weight) during
the first 24 hours post burn. In addition to LR resuscitation,
children weighing less than 30 kg also received maintenance
fluids and electrolytes based on the Holliday-Segar formula
in the form of isotonic saline solution (ISS) plus glucose
to maintain normoglycemia while in a fasting state, which
was gradually tapered down according to the rate of enteral
feeding advancement. Enteral feeding was introduced as
soon as possible, approximately 6 hours after arrival at the
hospital. After 24 hours, the volume of LR solution was
reduced to 1.5 mL × TBSA × weight, associated with half of
the ISS volume.
Participants assigned to the intervention group received
colloid in the form of 5% human albumin solution (0.5 g
of albumin per kg body weight) between 8 and 12 hours
after the burn accident (4-hr infusion) once daily for 3
days. Participants assigned to the control group followed
the same dosing regimen consisting of 4-hour infusion of
5% human albumin solution once daily for 3 days, but the
first albumin dose was infused later at 24 hours after injury.
Morphine, ketamine, and midazolam were used as drugs for
sedoanalgesia in moderate and individually adjusted doses
to control pain and to prevent “opioid creep.” Fentanyl was
not used.
www.pccmjournal.org e281
 Dittrich et al
Monitoring
Urine output (UO) was measured hourly via indwelling uri-
nary catheters, and adequate UO was defined as 1–2 mL/kg/hr.
The LR infusion was maintained throughout fluid resuscita-
tion (even during and after albumin administration) in the
two groups, but it was titrated to each patient’s individual UO.
The LR infusion rate was titrated based on UO as follows: 1)
UO less than 1 mL/kg/hr—LR infusion rate was increased by
10% to achieve the target UO range; 2) UO greater than 2 mL/
kg/hr associated with hemodynamic stability—LR infusion
rate was decreased by 10% to achieve the target UO range.
UO control and infusion rate titration were performed hourly
during resuscitation. The total infused volume of LR and UO
values was recorded over the first 72 hours. These values were
obtained from data recorded during the monitoring of each
individual patient in the ICU.
Outcome Measures
There are currently no studies that establish a set of criteria
for the diagnosis of fluid creep. Therefore, in the present study,
patients were evaluated for the presence of edema between 24
and 36 hours post burn by two members of the medical team
with no involvement in the trial. The presence of edema in
unburned areas was considered a major criterion for the diag-
nosis of fluid creep. In addition, the presence of at least one
of the following objective criteria was also required to charac-
terize the development of fluid creep: 1) bilateral pulmonary
infiltrates on chest x-ray; 2) cardiomegaly; 3) pleural effusion;
4) presence of abdominal compartment syndrome; 5) need for
escharotomy or fasciotomy; and/or 6) wound deepening, char-
acterized by the progression of skin lesions from second- to
third-degree injury as determined by the plastic surgery team
24 hours after hospital admission. Table 1 shows the criteria
used by the independent examiners to grade the development
of fluid creep.
The primary endpoint with respect to the efficacy of early
albumin infusion was the difference in the occurrence of fluid
creep and reduction in crystalloid fluid infusion rates between
the two groups during acute fluid resuscitation (3 d post burn).
Table 1. Criteria Used in the Diagnosis of
Fluid Creepa
Major criterion
Edema in unburned areas (3+/4+ or 4+/4+)
Minor criteria
Pulmonary congestion
Cardiomegaly
Pleural effusion
Deepening of burn wounds
Need for escharotomy or fasciotomy
Abdominal compartment syndrome
A diagnosis of fluid creep was made in the presence of the major criterion
a
associated with at least one of the minor criteria.
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The secondary efficacy endpoint was the proportion of patients
having a reduction in length of hospital stay in the interven-
tion group (early albumin infusion) when compared with the
control group (delayed albumin infusion). The same hospital
discharge criteria were used for both groups: complete epithe-
lialization of acute wounds; full integration of skin grafts; and
resolution of infections.
Statistical Analysis
Continuous variables are expressed as mean and sd or
median and interquartile range, and categorical variables are
expressed as absolute and relative frequencies. Fisher exact
test or the chi-square test were used to compare and evaluate
associations between categorical variables. The Student t test
or Mann-Whitney U test were used to compare and evaluate
associations between continuous variables. Statistical analysis
was performed using SPSS, version 18.0, and the level of sig-
nificance was set at p value of less than or equal to 0.05.
RESULTS
From June 2012 to January 2014, 110 children with burns
were admitted to the burn center of the institution and
assessed for eligibility. Of these, 62 were not eligible and two
did not give consent. Of 46 patients, 23 were randomized to
receive early albumin infusion during resuscitation and 23
to delayed albumin infusion (control). Figure 1 shows the
flow of participants, including the reasons for exclusions.
The demographic characteristics of the study sample are
described in Table 2.
Clinical findings, length of hospital stay, and the total vol-
ume of fluid (including albumin, LR, and ISS) infused per
group over 3 days post burn are shown in Table 3. The cumu-
lative prevalence of fluid creep in the study sample was 30.43%
(n = 14). Of these, only one case occurred in the intervention
group (4.3%). When groups were compared, there was a signif-
icant association between undergoing intervention (early albu-
min infusion) and not showing edema (p = 0.001). The relative
risk for developing fluid creep in the intervention group was
0.0769 (95% CI, 0.0109–0.5407). Of the 14 patients with fluid
creep, 12 developed pulmonary edema, cardiomegaly, and sub-
sequent pneumonia, one had pleural effusion, and six patients
required ventilatory support. Five children had deepening of
wounds, and two of them required extremity escharotomy.
However, there was no significant difference between groups
regarding the number of surgical procedures (debridement
and grafting) performed.
Patients in the intervention group required less crystalloid
fluid than controls over the first 3 days post burn (p = 0.025 on
day 1; p = 0.002 on day 2; and p = 0.002 on day 3). The median
UO showed no difference between groups. Duration of hos-
pitalization was shorter for patients in the intervention group
than for controls (p = 0.004) (Table 3).
There were no cases of intra-abdominal hypertension or
death in the sample studied. No gastrointestinal complications
were observed in either group during enteral feeding advance-
ment. None of the patients required parenteral nutrition.
June 2016 • Volume 17 • Number 6

Figure 1. Study flowchart. TBSA = total body surface area.
DISCUSSION
There is still some controversy regarding the use of albumin
in the treatment of burn patients. Fluid resuscitation of chil-
dren with burn injuries is a major challenge due to greater
intolerance to overresuscitation or underresuscitation and to
their diminished physiologic reserve compared with burned
adults. We hypothesized that albumin administered at 8–12
hours, rather than 24 hours after burn injury would reduce
fluid requirements, fluid creep, and length of hospital stay in
children with extensive burns. Our hypothesis was confirmed
as early albumin infusion allowed a reduction in fluid require-
ments on day 1 (−31.9%), maintenance of the reduced fluid
requirements on day 2 (−19.37%), and ending resuscitation
with a significantly lower fluid volume (−45.3%) on day 3
compared with delayed albumin infusion. Significantly fewer
cases of fluid creep and shorter hospital stay were also observed
among patients who received albumin earlier. In addition, the
control group showed behavior similar to that observed by
Chung et al (19) in a study that revealed progressively greater
fluid volume requirements in the resuscitation sequence when
beginning with excessive fluid amounts. The main com-
plications observed in the present sample were pulmonary
edema and cardiomegaly, with subsequent pneumonia and
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wound deepening. Because the sample consisted of moderate
burns, the most serious complications of fluid creep were not
observed.
Control of excessive fluid infusion with the inclusion of
colloid in the resuscitation strategy for burn victims has been
consistently demonstrated (1, 20, 21). Earlier colloid admin-
istration during resuscitation can reduce the total amount of
fluid required due to the restoration of Starling forces and/or
of endothelial glycocalyx (16, 22, 23).
The reduction in fluid loss to the interstitium reduces the
likelihood of developing fluid creep and its complications (13).
By controlling the development of fluid creep, we also aim to
minimize wound deepening in an attempt to reduce the num-
ber of surgical procedures, thus accelerating skin recovery and
allowing hospital discharge as early as possible. This, in turn,
may reduce morbidity and treatment costs, which are often
very high (24).
More recently, some authors have recommended the use
of colloid even within the first 24 hours of the accident. The
Galveston protocol includes albumin administration begin-
ning 8 hours after the accident, and the patient is eligible for
colloid replacement if serum albumin levels are less than or
equal to 2.5 g/dL (25).
Some studies have advocated colloid infusion at 12 hours
after the burn event if the fluid requirement exceeds 120%
of normal or if the scheduled 24-hour resuscitation exceeds
6 mL/kg/hr when approaching the 12th hour after the accident
(1, 19, 26). In the present study, fluid creep was observed in
56.5% of patients receiving delayed albumin infusion (con-
trol group) and in only 4.3% in the early albumin group. This
difference may be explained by the fact that the pathophysi-
ological process of edema formation occurred naturally in the
control group, with no interruption of the event. Because these
patients did not receive early albumin infusion, their crystal-
loid fluid infusion rate could not be concomitantly reduced.
In the intervention group, however, there was no fluid leakage
from the intra- to extravascular space, except in one patient.
The cumulative prevalence of fluid creep was 30.43%, lower
than that reported in the literature, where approximately 60%
of patients with burns greater than 20% TBSA will develop this
phenomenon. Engrav et al (27) observed fluid creep in 58% of
their patients. Other authors have reported fluid creep rates
ranging from 84% to 100% (28–30). We can infer that our
reduced rate of fluid creep occurred because patients received
human albumin as a primary resuscitation strategy, thus pre-
venting the development of edema and its complications,
whereas in most studies, colloid is used in cases that already
have a high crystalloid requirement, i.e., as a rescue strategy.
The main monitoring variable in the current study was UO,
with the target range of 1–2 mL/kg/hr according to our Burn
Center’s protocol. This parameter served as a guide for the
rigorous titration of fluid administration in both groups. UO
remains the most important indicator in the monitoring of burn
patients, which may be perceived as a paradox given the wide
selection of monitoring devices currently available for use in the
ICU. The American Burn Association guidelines for burn shock
www.pccmjournal.org e283
 Dittrich et al

Table 2. Characteristics of Patients in the Intervention Group (Early Albumin Infusion) and
Control Group (Delayed Albumin Infusion)
Groups

Variables Intervention (n = 23) Control (n = 23) p

Age (mo), median (IQR) 37 (22–53) 31 (12–64) 0.481

Weight (kg), median (IQR) 14 (12.7–17) 14 (11–18) 0.733
z score, n (%)
≥ −2 and ≤ +2 20 (86.95) 21 (91.3) 0.363
≥ –3 and < –2 3 (13.04) 1 (4.34)
> +2 0 1 (4.34)
% Total body surface area, median (IQR) 16 (15–18) 17 (15–22) 0.498
Sex, n (%)
Male 15 (65.2) 13 (56.5) 0.546
Female 8 (34.8) 10 (43.5)
Cause, n (%)
Scald 15 (65.2) 17 (73.9) 0.749
Fire 8 (34.8) 6 (26.1)
Pediatric Risk of Mortality Score, median (IQR) 6 (5–8) 7 (6–9) 0.162
Abbreviated Burn Severity Index, median (IQR) 4 (4–5) 5 (4–6) 0.230
IQR = interquartile range.

Table 3. Results Obtained With Albumin Infused Between 8 and 12 Hours (Intervention
Group) and 24 Hours (Control Group) Post Burn
Groups

Variables Intervention (n = 23) Control (n = 23) p

Volumea (mL/kg/% total body surface area), median (IQR)

Day 1 2.49 (1.68–2.44) 3.05 (2.02–3.78) 0.025
Day 2 1.2 (1.08–1.47) 1.71 (1.28–2.37) 0.002
Day 3 0.82 (0.59–1.12) 1.3 (0.9–1.7) 0.002
Urine output (mL/kg/hr), median (IQR)
Day 1 2.1 (1.74–2.2) 2 (1.1–2.18) 0.152
Day 2 2.58 (1.92–3.4) 2.54 (2.12–4.22) 0.482
Day 3 2.9 (1.91–3.4) 3 (2.19–5.15) 0.093
Fluid creep, n (%) 1 (4.3) 13 (56.5) 0.001
Length of stay (d), median (IQR) 14 (10–17) 18 (15–21) 0.004
IQR = interquartile range.
Total volume of fluids.
a

resuscitation recommend a UO of 0.5–1 mL/kg/hr in adults and
1–1.5 mL/kg/hr in children weighing less than 30 kg (31). UO is
also an important marker of progress, as it allows the adjustment
of fluid infusion over time according to the patient’s individual
response (26). There is no benefit associated with above-normal
blood volumes, and the attempt to normalize the central venous
pressure and pulmonary artery pressure should be avoided (13)
and may be a cause of fluid creep (16).
The delicate balance of fluid infusion to achieve an adequate
UO while limiting hypoperfusion or fluid creep is complicated

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and depends on appropriate professional experience. There is
a natural tendency in clinical practice to increase the rate of
fluid infusion in situations of inadequately low UO. However,
significantly less effort is devoted to reduce the rate of fluid
infusion when UO is above the target range (6, 32). As the UO
increases and clinical parameters are stabilized, a decrease in
the rate of crystalloid fluid infusion is mandatory, and titra-
tion should progress throughout the entire resuscitation (1, 6).
To reduce the dependence of the titration volume on clinical
decisions, some centers have implemented clinical protocols
using standard algorithms based on the UO to guide the timely
reduction in the rate of fluid infusion (1, 2, 5, 16, 26, 33), and,
more recently, other centers have implemented computer-
ized algorithm-based decision support systems linking fluid
administration with UO data input, a promising closed-loop
concept for burn resuscitation (34).
Cartotto and Zhou (7) showed that 75% of resuscita-
tions performed at their burn center used a crystalloid vol-
ume greater than 4.3 mL/kg/%TBSA, with a mean volume of
6.3 mL/kg/%TBSA used in resuscitations in this same group
of patients, with UO above the desired range. In the pres-
ent study, the reduction in fluid volume did not lead to a
decrease in UO during resuscitation, demonstrating that the
infused volume was safely reduced without compromising
hydration.
It is clear that the success of resuscitation is related to the
administration of lower fluid volumes and that we are redis-
covering what Baxter described decades ago (35). Colloids
appear to be an essential component for the resuscitation of
severely burned patients, a more rapid restoration of blood
volume, and prevention of fluid creep. Further studies are
required to determine the extent of burns for which resuscita-
tion should be performed with the use of human albumin and
the best time to use this type of strategy.
Limitations
This study was conducted at a single center. Other limita-
tions include the difficulty in accounting for insensible water
loss, absence of a more strict computer-based resuscitation
protocol, and the target UO range of 1–2 mL/kg/hr. The UO
range of 1–1.5 mL/kg/hr recommended as safe for pediat-
ric resuscitation (31) has been gradually reduced, and more
recently, a UO target of 0.5 to 1 mL/kg/hr in the first 48 hours
of fluid resuscitation has become a trend in the monitoring
of pediatric patients (13, 16). In our center, safety in the use
of this UO target by a medical team operating in a mixed
unit is consistent with the learning curve and adherence to
protocols.
CONCLUSIONS
Earlier albumin infusion, between 8 and 12 hours after injury,
in pediatric patients with burns greater than 15–45% TBSA
reduced the need for crystalloid fluid infusion during resus-
citation. Furthermore, significantly fewer cases of fluid creep
and shorter hospitalization were observed in this group of
patients.
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