s12871 015 0064 2 PDF
s12871 015 0064 2 PDF
s12871 015 0064 2 PDF
RESEARCH ARTICLE
Open Access
Abstract
Background: Major abdominal surgery is associated with significant risk of morbidity and mortality in the
perioperative period. Optimising intraoperative fluid administration may result in improved outcomes. Our aim
was to compare the effects of central venous pressure (CVP), and central venous oxygen saturation (ScvO2)-assisted
fluid therapy on postoperative complications in patients undergoing high risk surgery.
Methods: Patients undergoing elective major abdominal surgery were randomised into control and ScvO2 groups. The
target level of mean arterial pressure (MAP) was 60 mmHg in both groups. In cases of MAP < 60 mmHg patients
received either a fluid or vasopressor bolus according to the CVP < 8 mmHg in the control group. In the ScvO2 group,
in addition to the MAP, an ScvO2 of <75 % or a >3 % decrease indicated need for intervention, regardless of the actual
MAP. Data are presented as mean standard deviation or median (interquartile range).
Results: We observed a lower number of patients with complications in the ScvO2 group compared to the control
group, however it did not reach statistical significance (ScvO2 group: 10 vs. control group: 19; p = 0.07). Patients in the
ScvO2 group (n = 38) received more colloids compared to the control group (n = 41) [279(161) vs. 107(250) ml/h;
p < 0.001]. Both groups received similar amounts of crystalloid (1126 471 vs. 1049 431 ml/h; p = 0.46) and
norepinephrine [37(107) vs. 18(73) mcg/h; p = 0.84]. Despite similar blood loss in both groups, the ScvO2 group
received more blood transfusions (63 % vs. 37 %; p = 0.018). More patients in the control group had a postoperative
PaO2/FiO2 < 200 mmHg (23 vs. 10, p < 0.01). Twenty eight day survival was significantly higher in the ScvO2 group
(37/38 vs. 33/41 p = 0.018).
Conclusion: ScvO2-assisted intraoperative haemodynamic support provided some benefits, including significantly
better postoperative oxygenation and 28 day survival rate, compared to CVP-assisted therapy without a significant
effect on postoperative complications during major abdominal surgery.
Trial registration: ClinicalTrials.gov NCT02337010.
Keywords: Haemodynamic management, Central venous oxygen saturation, Postoperative complications
* Correspondence: andrasmikor@gmail.com
1
Department of Anaesthesiology and Intensive Therapy, University of Szeged,
6. Semmelweis str., 6725 Szeged, Hungary
Full list of author information is available at the end of the article
2015 Mikor et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
Background
There are an estimated 234 million surgical operations
worldwide every year, with significant risk of morbidity
and mortality in the perioperative period in patients
undergoing major surgery [1]. Following the implementation of safety standards outcomes after anaesthesia
have improved, although estimations of perioperative
complications and postoperative morbidity are difficult.
It has been suggested this may be between 3 and 17 % of
cases [2, 3].
Several studies have revealed that inappropriate intraoperative fluid therapy may be responsible for postoperative complications and organ failure. Excessive fluid
administration during surgical procedures may lead to
more frequent postoperative complications [4, 5], while
restrictive fluid therapy may improve outcome after
major elective gastrointestinal surgery [6]. On the other
hand, fluid restriction may increase the level of hypovolemia and hence hypoperfusion, and thereby increased incidence of postoperative complications [7].
It is well known, that using heart rate (HR), mean
arterial pressure (MAP) and central venous pressure
(CVP) to assess and guide haemodynamic support may
be misleading [810].
Advanced haemodynamic monitoring, using cardiac
output, stroke volume, stroke volume variation (SVV),
pulse pressure variation (PPV) to guide intraoperative
fluid therapy has resulted in improved outcomes in
several studies [1114]. Despite the increasing evidence,
advanced haemodynamic monitoring has not become
routine practice and, in high risk patients, arterial and
central venous pressure monitoring remain the most
common tools applied in more than 80 % of cases in
Europe and in the United States [15]. One of the reasons
may be that accurate measurement of cardiac output,
SVV and PPV require advanced instrumentation.
Another important factor for haemodynamic stability
is the balance between oxygen delivery (DO2) and consumption (VO2). Unfortunately, detailed haemodynamic
evaluation, including DO2/VO2 balance, for every high
risk patient in the operating theatre is not feasible. The
most often used bedside parameter to assess the relationship between oxygen supply and consumption is the
central venous oxygen saturation (ScvO2). Continuous
monitoring of the ScvO2 is also possible with a device
based on fiber-optic technology via a standard central
venous catheter. Values measured by this approach have
shown good correlation with laboratory values [16].
ScvO2 reflects important changes in the DO2/VO2 relationship, has been found to be useful during high-risk
surgery, and low ScvO2 is associated with increased
postoperative complications [17, 18]. Despite these
theoretical advantages, ScvO2 is only used in 1230 %
of high risk surgical patients [15]. In clinical routine,
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MAP and CVP are the most frequently applied monitoring tools (7595 %) during high risk surgery [15],
despite convincing evidence that neither can predict
fluid responsiveness [810].
Therefore, the aim of the current study was to compare the effects of ScvO2 assisted intraoperative
haemodynamic support to the routinely used MAPCVP approach on postoperative complications in high
risk surgical patients.
Methods
Patients
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Control group
MAP<60 mmHg
ScvO2<75% or
>3%
ScvO2<75%
Yes
No
HES 250 ml
NE 10 mcg
Yes
HES 250 ml
HES 250 ml
No
NE 10 mcg
Fig. 1 Flowchart of the study design. MAP: mean arterial pressure, CVP: central venous pressure, ScvO2: central venous oxygen saturation, HES:
hydroxyethyl starch, NE: norepinephrine
Statistics
All data are presented as mean SD or median (interquartile range) as indicated by data distribution tested
by the Shapiro-Wilk test. Independent samples T-test or
MannWhitney U test were used to compare the data
between the two groups depending on data distribution
in each measurement. To evaluate changes in the measured parameters over time within the groups, two-way
analysis of variance (ANOVA) was used. To assess the
difference between categorical data we used Pearsons
chi-squared test.
The main outcome parameter was the incidence of
postoperative complications on the first and second
postoperative day. We calculated the number of patients
observed with pulmonary, circulation, abdominal, renal,
infectious or surgical complications based on a previous
study by Mayer at al. [22]. Following completion of the
study, respiratory complications and acute kidney injury
were analysed post hoc. Pulmonary function was
assessed by using the ratio of arterial partial oxygen tension and the fraction of inspired oxygen (PaO2/FiO2)
according to the Berlin definition of acute respiratory
distress syndrome [23]. To assess the severity of kidney
disease we used the Kidney Disease Improving Global
Outcome (KDIGO) acute kidney injury definition [24].
Secondary end points were the difference in intraoperative fluid and vasopressor requirements. Based on the results of a previous study on a similar patient population
[22], it was found that in the control group the incidence
of organ dysfunction was 50 %, whereas in the goal directed therapy group it was only 20 % (i.e. the difference
was 30 %). Therefore, to have 80 % power if the p < 0.05
with Pearsons chi-squared test, the required number of
patients should be a minimum of 40 per group. For
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Ethical approval for this study (2618 2/2010.) was provided by the Regional Ethical Committee of University
of Szeged, Albert Szent-Gyrgyi Health Center, Szeged,
Hungary (Chairperson: Prof. Tibor Wittmann) in 2010.
Results
Eighty five patients met the inclusion criteria between
2011 and 2013. One patient was excluded due to chronic
renal failure hence 42 patients were randomized to each
group. Four patients in the ScvO2 group and 1 patient in
the control group had to be withdrawn from the study
due to the inoperability of the tumour (Fig. 2). There
were no significant differences between the two groups
regarding demographics and clinical characteristics. Five
patients in the control group were not extubated at the
end of the surgery, 4 of whom were extubated on the
first postoperative day and one patient was ventilated for
11 days. In the ScvO2 group, all patients were extubated
at the end of surgery apart from 2 patients who were
extubated on the first postoperative day and 1 patient
who was ventilated for 3 days. Following extubation all
patients received oxygen supplementation via a 28 % or
40 % Venturi face mask to maintain SaO2 > 94 %. Two
patients died in the ICU in the control group with
28 days survival also significantly lower in this group
(Table 1).
There was no significant difference in ScvO2 between
the two groups at baseline. During the operation there
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Table 1 Demography of the patients. Data are shown as mean SD or median (interquartile)
Age (years)
ScvO2 (n = 38)
Control (n = 41)
62 8
62 8
0.95
Sex (M/F)
28/10
29/12
0.77
APACHE II
12 4
11 5
0.37
3 (2)
3 (2)
0.663
247 82
254 45
0.76
22
29
38/0
39/2
0.17
37/1
33/8
0.018*
*: p<0.05
95
ScvO2 (%)
90
85
80
Control
ScvO2
75
70
65
60
0
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120
MAP (mmHg)
110
100
90
80
Control
ScvO2
70
60
50
40
0
Discussion
In this prospective randomised study we found that ScvO2
and MAP based intraoperative haemodynamic management resulted in more intraoperative interventions, better
18
CVP (mmHg)
16
14
12
10
Control
ScvO2
8
6
4
2
0
0
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ScvO2 (n = 38)
Control (n = 41)
Crystalloid (ml/h)
1126 471
1049 431
Colloid (ml/h)
279 (161)
107 (250)
11
15
0.47
0.46
<0.001*
37 (107)
18 (73)
0.84
24
15
0.02*
973 473
983 574
0.99
*: p<0.05
Lactate (mmol/l)
4
3,5
3
2,5
2
Control
ScvO2
1,5
1
0,5
0
0
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Table 3 Postoperative complications within 48 h after the operation. Data are shown as number of patients with each complication.
KDIGO: Kidney Disease Improving Global Outcomes staging
Infection
Control (n = 41)
0.33
Abdominal
0.94
Urinary tract
0.33
Wound
0.11
Cardiac decompensation
Arrhythmia
0.19
Vasopressor need
14
0.31
Circulation
Abdominal
ScvO2 (n = 38)
Respiratory
Stroke
Constipation
0.71
0.33
Re-operation
0.60
0.34
0.96
0.33
10
19
0.07
Perioperative deaths
Number of patients with complications
>300 Hgmm
PaO2/FiO2
0.62
200300 Hgmm
24
15
0.02*
100200 Hgmm
10
22
0.01*
0.52
no injury
27
29
0.59
KDIGO 1
10
0.36
KDIGO 2
0.28
KDIGO 3
0.73
<100 Hgmm
*: p<0.05
It has been shown that static preload parameters, including CVP, have limited clinical value in guiding
heaemodynamic support and may also be inadequate
for predicting fluid responsiveness [10, 37]. In our
study there was no significant difference at any time
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Conclusions
In the current study, using ScvO2 as a haemodynamic
end-point in addition to MAP, resulted in more intraoperative fluid administration and transfusion during
major abdominal surgery. Based on our results, as the
insertion of a central venous line is part of the routine
management of these surgical procedures, instead of
advanced haemodynamic monitoring, ScvO2 assisted
intraoperative haemodynamic management may be a
useful alternative and may also lead to improved outcomes. This study also supports our previous assumption that if ScvO2 is used during general anaesthesia,
higher levels should be considered as a target value
than in the critical care setting.
Abbreviations
APACHE: Acute physiology and chronic health evaluation; CRP: C-reactive
protein; CVP: Central venous pressure; DO2: Oxygen delivery; FiO2: Fraction of
inspired oxygen; HES: Hydroxyethyl starch; HR: Heart rate; KDIGO: Kidney
disease improving global outcome; MAC: Minimum alveolar concentration;
MAP: Mean arterial pressure; PCT: Procalcitonin; PPV: Pulse pressure variation;
SaO2: Arterial oxygen saturation; ScvO2: Central venous saturation; SVV: Stroke
volume variation; VO2: Oxygen consumption.
Competing interests
Dr Molnar is the member of the PULSION Medical Advisory Board, and
receives occasional honoraria for lectures. The rest of the authors declare
that they have no competing interests.
Authors contributions
AM participated in acquisition, analysis and interpretation of data, drafted
the manuscript. DT, MFN, AO participated in enrolling patients, acquisition,
analysis and interpretation of data. SzK, IK, GD participated in the design of
the study and acquisition of data. ZsM conceived of the study, participated
in its design and coordination and helped to draft the manuscript. All
authors read and approved the final manuscript.
Acknowledgements
No funding bodies were involved during the preparation and conduction of
our study. We would like to thank Mrs. Harriet Adamson in helping us as a
language editor finalizing our manuscript.
Author details
1
Department of Anaesthesiology and Intensive Therapy, University of Szeged,
6. Semmelweis str., 6725 Szeged, Hungary. 2Hungarian Defence Forces
Medical Center, Budapest, Hungary.
Received: 14 December 2014 Accepted: 23 May 2015
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