CARDIOVASCULAR JOURNAL OF AFRICA • Volume 28, No 3, May/June 2017
192
AFRICA
with the amended Declaration of Helsinki and Good Clinical
Practice regulations. Written informed consent was obtained
from all subjects. Patients admitted to the Department of
Cardiovascular Surgery of our tertiary centre between June 2006
and February 2007 who had type 2 diabetes mellitus and had
undergone CABG surgery constituted the study group.
Patients were divided into two groups with block
randomisation, using the sealed envelope technique: group
T (telmisartan group) consisted of patients who received the
angiotensin receptor blocking agent, telmisartan (Micardis
®
,
Boehringer Ingelheim, Istanbul, Turkey) 80 mg daily for
at least six months in the pre-operative period; group N-T
(non-telmisartan group) consisted of patients who received
neither telmisartan nor any other angiotensin receptor blockers.
In both groups, no patients were using angiotensin converting
enzyme inhibitors for at least six months prior to the study.
Cases with severely impaired left ventricular function, chronic
pulmonary obstructive disease, severe systemic non-cardiac
disease, severe renal or liver impairment, infectious diseases
before surgery, malignancy, those receiving corticosteroids or
other immunosuppressive treatment, and patients with stroke,
inflammatory disease, and/or previous cardiac surgery, and
valvular heart disease were excluded from the study.
Surgical technique and postoperative care
Cardiac medication, including beta-adrenergic blocking agents,
calcium channel blocking agents and nitrates, was continued
until the morning of surgery. The same general anaesthetic drugs
were used in all patients. A standard median sternotomy incision
was used to expose the heart and place the internal mammary
artery and saphenous vein grafts used for coronary anastomosis.
In each group, routine surgery was performed using a
membrane oxygenator (Edwards Vital, Edwards Lifesciences
LLC, Irvine, CA, USA), a 3-mg/kg dose of sodium heparin,
2 000 ml of Ringer’s lactate primer and a roller pump at a body
temperature of 28°C. Cardiopulmonary bypass was instituted
via the ascending aorta and single two-stage venous cannulation
(maintained at 2.2–2.4 l/min/m
2
).
Following cross-clamping of the aorta, the heart was arrested
using 10–15 cm
3
/kg cold blood cardioplegia through the aortic
root and topical ice slush was continued every 20 minutes for
myocardial protection. Heparin was neutralised with protamine
hydrochloride (Protamin 1000; Roche, Istanbul, Turkey). The
circuit was primed with 2 000 ml Ringer’s lactate.
After completion of the surgery, patients were transferred
to the intensive care unit (ICU), where standard care and
processes were followed until discharge. Patients were weaned
from mechanical ventilation when they were haemodynamically
stable, responding to verbal stimulation, and had been fully
rewarmed. Patients were discharged from the ICU if they were
haemodynamically stable, had normal blood gasses during
spontaneous breathing, and had a satisfactory renal function.
Outcome parameters and other variables
Smoking, obesity, hypertension, duration of diabetes, family
history of coronary artery disease, pre-operative myocardial
infarction, and pre-operative haemodynamic data were recorded.
During the surgical procedure, haemodynamic parameters,
including heart rate, mean arterial pressure, central venous
pressure, arterial blood gasses and urine output were monitored.
In the postoperative period in the ICU, cardiovascular and
respiratory values and temperature were recorded every 15
minutes before extubation and then hourly until discharge from
the ICU. The length of stay in the ICU was also recorded.
Microalbuminuria levels were studied pre-operatively, on the
first hour postoperatively, and on postoperative days (POD) one
and five. High-sensitivity C-reactive protein (hsCRP) levels were
studied pre-operatively, and on POD 1 and 5. Patients who were
considered to be in a low-cardiac output state received positive
inotropic agents (dopamine or adrenaline or both). They were
assessed for persistent systemic blood pressure below 90 mmHg,
urinary output lower than 20 cm
3
/h, and the state of peripheral
circulation was evaluated for adequate preload and optimal
afterload. Urine samples were measured for microalbuminuria
using Micral test sticks (Roche).
Statistical analysis
Categorical variables were analysed with chi-squared and Fisher’s
exact tests, as appropriate, in contingency tables, whereas the
unpaired
t
-test and Mann–Whitney
U
-test were performed,
as appropriate, for comparison of continuous variables.
Comparisons for microalbuminuria and hsCRP levels in the
groups were done with repeated measures of ANOVA and the
Bonferroni test.
Data are expressed as means
±
standard deviation. A
p
-value
<
0.05 was considered statistically significant. All statistical
analyses were performed with the Statistical Package for Social
Sciences (SPSS 10.0 for Windows, SPSS, Inc., Chicago, IL).
The calculation of sample size was based on a power analysis.
At a power of 80% using a significance level of
p
<
0.05, the
sample size required was 20 subjects per study group.
Results
Forty patients met the eligibility criteria for the study. Of the 40
patients (29 males, 11 females) whose charts were reviewed, the
average age was 65.0
±
8.6 (range 40–79) years. Group T included
20 patients (15 males, 5 females) with a mean age of 65.6
±
7.8
years, who had been using telmisartan 80 mg daily for at least six
months. Group N-T included 20 patients (14 males, 6 females)
with a mean age of 64.4
±
9.5 years, who used no angiotensin
receptor blocking agent prior to the operation. The groups were
similar with regard to age and gender (
p
=
0.680 and
p
=
0.723,
respectively).
With regard to clinical characteristics such as body mass
index, smoking habit, hypertension, hyperlipidaemia, and
history of myocardial infarct, the two groups did not show
significant differences and were comparable (Table 1). The
groups were also similar with regard to number of bypass grafts,
cardiopulmonary bypass time, cross-clamp time, flow, atrial
fibrillation, inotrope usage, time of endotracheal intubation and
mortality rate (Table 2).
Pre-operative, first hour postoperative, POD 1 and POD 5
microalbuminuria levels were 16.5
±
17.2, 28.5
±
17.2, 59.0
±
29.8 and 23.0
±
20.0 mg/l in group T, and 30.0
±
17.7, 51.0
±
28.4, 75.0
±
25.6 and 52.5
±
27.5 mg/l in Group N-T, respectively,
and there were statistically significant differences between four