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\begin{document}

\title{Evaluation of early postoperative period results of patients with type 2
diabetes taking oral anti-diabetics or insulin medications, with
microalbuminuria and normal creatinine levels after coronary artery
bypass.}



\author[1]{Huseyin Gemalmaz}%
\author[1]{cihan yücel}%
\affil[1]{Prof Dr Cemil Tascioglu City Hospital}%


\vspace{-1em}



  
  \date{May 23, 2024}


\begingroup
\let\center\flushleft
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\maketitle
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\selectlanguage{english}
\begin{abstract}
Introduction: In this study, we aimed to compare the early postoperative
period results of type 2 diabetes patients taking oral antidiabetics or
insulin medications, with microalbuminuria and normal creatinine levels
after coronary artery bypass. Materials and methods: Eighty patients
with type 2 diabetes and taking oral antidiabetics or receiving insulin
medication all with normal creatinine levels with microalbuminuria were
included in this study. Preoperative creatinine values of the patients,
albumin levels in spot urine, creatinine levels on the postoperative 3rd
day, duration of ventilation, amount of drainage, length of stay in the
intensive care unit, length of stay in the hospital, mediastinitis and
mortality rates were recorded. Results: A statistically significant
increase in creatinine was found in both taking oral antidiabetics type
2 diabetes and insulin medication patient groups with microalbuminuria.
When the two groups were compared with each other, increase in
creatinine levels of the patients using insulin was higher than the
patients taking oral antidiabetics, and was statistically significant.
Conclusion: According to the result of our study it can be suggested
that postoperative creatinine elevation is observed in patients with
type 2 diabetes mellitus with microalbuminuria and with normal
creatinine levels, either having insulin medication or not. The
elevation is higher in patients having insulin medication while other
results are similar, except for impaired renal function. Keywords: Type
2 diabetes mellitus, insulin, microalbuminuria, coronary artery bypass.%
\end{abstract}%



\sloppy


\textbf{Introduction}

It is known that coronary artery bypass surgery is the most effective
treatment method for angina pectoris seen in coronary artery diseases
and increases long-term survival(1). Although it is widely used for this
purpose worldwide, it causes end organ damages, multiple organ ischemia,
necrosis, and consequently mortality and morbidity(2). The vast majority
of coronary artery bypass surgeries are performed on-pump and various
proinflammatory effects such as non-pulsatile blood flow, low mean blood
pressure, and hypothermia occur(3). Neurological, pulmonary and renal
dysfunctions, superficial and deep tissue infections can be seen as a
result of cardio pulmonary bypass(4, 5, 6, 7).

Classically, microalbuminuria is known as a parameter indicating renal
damage. Barriers in the glomeruli prevent macromolecules such as albumin
passing into the ultrafiltrate. Albumin which passes to the
ultrafiltrate in a small amount is reabsorbed from the proximal tubules
and some of it is metabolized and broken down into amino acids. Hence
there is a small amount of albumin in the urine. If the glomerular
barrier and proximal tubule reabsorption is impaired, the amount of
urine albumin increases. This shows us proximal tubule damage and
indirectly interstitial inflammation and functional loss in the
kidney(8).

Following the consensus that microalbuminuria indicates the loss of
kidney function, new hypotheses developed on the idea that urinary
albumin excretion is a parameter that increases the risk of
cardiovascular disease. Among them, it has come to the fore that
microalbuminuria is associated with the loss of general vascular
functions and consequently it is an indicator of a high level of
cardiovascular disease and kidney function loss (9). Based on this, it
was thought that loss of vascular endothelial function might be a cause
of vascular albumin leakage and it was concluded that albumin leakage in
renal vessels was related to general vascular permeability(10).

Diabetes is known as an independent risk factor for cardiovascular
diseases(11). In addition, every 1\% increase in Hemoglobin A1c (HbA1c)
level in diabetic diseases causes an increase of about 11\% in coronary
artery diseases(12). Especially in patients with insulin-dependent
diabetes microalbuminuria is considered as a sign of nephropathy and a
marker of the prevalence of atherosclerosis(13).

The aim of this study is to compare the mortality and morbidity results
on type 2 diabetes patients receiving insulin medications or taking oral
antidiabetics, all with microalbuminuria and normal creatinine values
after on-pump coronary artery bypass (CABG).

\textbf{Materials and Methods}

This prospectively planned study was conducted by including 80 patients
with microalbuminuria who underwent coronary artery bypass surgery in
our clinic between February 2019 and December 2020. For this study,
ethical approval was given by the local Ethics Committee and all
research was conducted in accordance with the Helsinki Declaration and
its later amendments or comparable ethical standards. The aim of the
study was clearly explained to all participants and their written
informed consent was obtained.

In this study, the exclusion criteria were as follows: Preoperative
chronic renal failure, preoperative dialysis, serum creatinine levels
above 1.2mg/dl for males and 1.1mg/dl for females, underwent emergency
surgery, active endocarditis, use of preoperative extracorporeal
membrane oxygenator. Patients who had insulin medication more than one
year were included in the group of having insulin medication while those
who had been receiving insulin for less than one year, were not
included.

Patients having insulin medication were using short-acting (regular
insulin) and/or long-acting (NPH) or mixed insulin. Those taking oral
antidiabetics were receiving metformin and/or stagliptin. The mean of
HbA1c was 7.1\% in the group using insulin, and 6.8\% in the group
receiving oral medication.

The records of the following risk factors were taken preoperatively:
Age, gender, body mass index (BMI), hypertension, chronic obstructive
pulmonary disease (COPD), smoking, whether they had an infarction in the
last 28 days, presence of peripheral artery disease (PAD), ejection
fractions, serum creatine and microalbuminuria levels in spot urine.

Albumin levels of 20-200 mg/L in spot urine were accepted as
microalbuminuria(14). The patients were divided into two groups, namely
as having insulin medication and taking oral antidiabetics. 42 patients
were in the insulin medication group and 38 patients were in the oral
antidiabetics medication group.

All operations were performed by the same surgical team, on-pump.
Stockert S5 Roller Pump (Sorin Group) and Terumo FX oxygenators were
used. Arterial cannula and single venous cannulation were applied from
the aorta after median sternotomy. Body temperature was reduced to 32
degrees. Cardiac arrest was achieved with the help of hyperpotassemic
isothermal blood cardioplegia. After the distal bypasses were made, the
cross clamp was lifted and the proximal anestomoses were side clamped.
pump outlet was inotrope, according to the need. In the diabetic patient
group, blood glucose regulation was achieved with continuous
crystallized insulin infusion.

Serum creatine levels on the postoperative 3rd day, duration of stay on
the ventilator after surgery, amount of drainage, length of stay in
intensive care unit (ICU), length of hospital stay, mediastinitis and
mortality rates of the patients were recorded. It was found in previous
publications that creatine levels increased 1-3 days after cardiac
surgery(15), and we thought that we would obtain the most reliable
results by recording creatine values on the 3rd day.

\textbf{Statistical Analysis}

The research data were uploaded to the computer using the ``SPSS
(Statistical Package for Social Sciences) for Windows 26.0 (SPSS Inc,
Chicago, IL)'' and evaluated. Descriptive statistics are presented as
mean and standard deviation. It was analyzed using quantitative
analytical methods (Mann-Whitney U, Student T and Wilcoxan test).
Statistical significance level was accepted as p\textless{}0.05.

\textbf{Findings and Statistics}

A total of 80 patients were included in this study, whose demographic
data are given in Table 1. There were no patients with chronic renal
failure in either group. In one patient among the diabetic patient
group, 24-hour urine output decreased to 800 cc and creatine levels
increased above 3.55 mg/dl on the postoperative 2nd day, the patient was
given inotrope support, furosemide infusion therapy and fluid
restriction. The patient entered the polyuric phase on the 4th
postoperative day without the need for hemodialysis and creatinine
levels decreased to normal on the 7th postoperative day.

\textbf{Hosted file}

\verb`image1.emf`  available at \url{https://authorea.com/users/427535/articles/531704-evaluation-of-early-postoperative-period-results-of-patients-with-type-2-diabetes-taking-oral-anti-diabetics-or-insulin-medications-with-microalbuminuria-and-normal-creatinine-levels-after-coronary-artery-bypass}

\textbf{*} Mann-Whitney U test

\textbf{Table 1.} Demographic characteristics of the groups (BMI: Body
mass index, COPD: Chronic obstructive pulmonary disease, MI: Myocardial
infarction)

There was no significant difference between the perioperative
cross-clamp times of the patients, total pump times and the number of
bypasses performed (Table 2).

As mediastinitis presented in one patient in the diabetic patient group,
antibiotic treatment was started according to the culture result and VAC
treatment was applied. While VAC of the patient was changed every 3
days, the wound culture was taken and followed up at the same time.
After reaching negative culture results twice the sternotomy incision
was closed primarily.

No hospital mortality was detected in our study.\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
& \textbf{Insulin Group} & \textbf{Insulin Group} & \textbf{OAD group} &
\textbf{OAD group} &\tabularnewline
\midrule
\endhead
& \selectlanguage{ngerman}\textbf{Mean±SD} & \textbf{Median(IQR)} & \selectlanguage{ngerman}\textbf{Mean±SD} &
\textbf{Median(IQR)} & \textbf{p*}\tabularnewline
\textbf{Cross Clamp Time} & 62,10\selectlanguage{ngerman}±11,07 & 62,00(17.25) & 59,67\selectlanguage{ngerman}±11,29 &
58,00(14,50) & 0,38\tabularnewline
\textbf{Total Pump Time} & 114,71\selectlanguage{ngerman}±13,99 & 115,00\selectlanguage{ngerman}±(22,75) & 113,90\selectlanguage{ngerman}±14,36
& 11350(20,25) & 0,82\tabularnewline
\textbf{Bypass Numbers} & 4,04\selectlanguage{ngerman}±0,58 & 4,00(0,00) & 4,10\selectlanguage{ngerman}±0,7 & 4,00(1,00)
& 0,92\tabularnewline
\bottomrule
\end{longtable}

*Mann-Whitney U test

\textbf{Table 2.} Perioperative data\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
& \textbf{Insulin Group} & \textbf{Insulin Group} & \textbf{OAD group} &
\textbf{OAD group} &\tabularnewline
\midrule
\endhead
& \selectlanguage{ngerman}\textbf{Mean±SD} & \textbf{Median(IQR)} & \selectlanguage{ngerman}\textbf{Mean±SD} &
\textbf{Median(IQR)} & \textbf{p*}\tabularnewline
\textbf{Microalbumin} & 34,60,10\selectlanguage{ngerman}±10,15 & 31,00(16.00) & 37,00\selectlanguage{ngerman}±20,75 &
30,50(16,75) & 0,78\tabularnewline
\textbf{Preoperative Creatinine} & 0,88\selectlanguage{ngerman}±0,16 & 0,85(0,19) & 0,93\selectlanguage{ngerman}±0,21 &
0,88(0,21) & 0,26**\tabularnewline
\textbf{Post-Op 3rd Day Creatinine Level} & 1,01\selectlanguage{ngerman}±0,18 & 0,95(0,27) &
1,33\selectlanguage{ngerman}±0,46 & 1,21(0,35) & \textbf{\textless{}0,001}\tabularnewline
\textbf{Duration of Stay on the Ventilator} & 7,67\selectlanguage{ngerman}±1,67 & 7,50(3,00) &
8,21\selectlanguage{ngerman}±2,44 & 8,00(3,00) & 0,57\tabularnewline
\textbf{Drainage Amount} & 567,85\selectlanguage{ngerman}±196,36 & 575,00(287,5) & 515,47\selectlanguage{ngerman}±154,00
& 500,00(212,50) & 0,27\tabularnewline
\textbf{Length of Stay in ICU} & 2,17\selectlanguage{ngerman}±0,72 & 2,00(1,00) & 2,64\selectlanguage{ngerman}±1,30 &
2,00(1,25 & 0,18\tabularnewline
\textbf{Length of Hospital Stay} & 7,92\selectlanguage{ngerman}±1,38 & 7,00(2,00) & 9,07\selectlanguage{ngerman}±3,13 &
8,00(3,00) & 0,11\tabularnewline
\bottomrule
\end{longtable}

\textbf{*} Mann-Whitney U test, \textbf{**} Student t test

\textbf{Table 3.} Preoperative and postoperative data.

\textbf{Hosted file}

\verb`image2.emf`  available at \url{https://authorea.com/users/427535/articles/531704-evaluation-of-early-postoperative-period-results-of-patients-with-type-2-diabetes-taking-oral-anti-diabetics-or-insulin-medications-with-microalbuminuria-and-normal-creatinine-levels-after-coronary-artery-bypass}

\textbf{Table 4.} Within-group creatinine elevation levels.

\textbf{Discussion}

At the end of this study we determined that the creatinine levels of
diabetic patients receiving insulin medication with normal creatinine
and microalbuminuria increased significantly on the post-op 3rd day,
when compared to the patients having oral antidiabetic medication.

It is known that cardiac surgery, which has been performed for many
years in the world, is a risky and difficult discipline in mortality and
morbidity compared to other surgical disciplines (16). Diabetes mellitus
is accepted as an independent risk factor especially for coronary
atherosclerosis, which concerns a wide age group(17). It is known that
diabetes alone increases mortality and morbidity in coronary artery
disease, both at younger ages and with more widespread involvement(18),
and in coronary artery bypass operations(19). The following can be
considered as main reasons for poor prognosis during and after surgery
due to diabetes: Severe cardiac disease, subclinical insufficiency in
renal functions in accompany, dehydration and electrolid disorders due
to hyperglycemia, arrhythminogenic, and increased fatty acids that
decrease myocardial oxygen demand(20,21). Since the effect of diabetes
on coronary bypass surgery is known to increase mortality and morbidity,
in our study, we aimed to investigate on type 2 diabetic patients using
insulin and taking oral antidiabetics in terms of kidney functions and
morbidity.

Today, most of the coronary artery bypass surgeries are performed
on-pump. We have done all the operations we have performed on-pump. It
is known that on-pump coronary artery bypass operations alone cause an
increase in renal functions and are an important cause of morbidity(22).
Loss of renal functions causes cardiac dysfunction, lung function
impairment, wound healing problems, and prolongation of stay intensive
care and hospital stays(23).

While microalbuminuria is seen as a marker of complications that develop
in diabetic patients, it is considered a sign of diabetic
nephropathy(24) and it is also known to increase early mortality in
these patients(25). It is accepted as a marker of atherosclerosis, which
is the cause of ischemic heart diseases in patients without
diabetes(26).

While clinical studies investigating the effects of microalbuminuria on
mortality and heart failure in cardiovascular diseases were previously
conducted we aimed to investigate diabetic patients using insulin and
taking oral antidiabetics(27). Studies on patients who had undergone
coronary artery bypass surgery were generally compared on patient groups
with and without microalbuminuria(28). In a study conducted by Kristina
S. and al. in 2015, patients with microalbuminuria who have type 2
diabetes were compared with non-diabetic patients(29). In our searches
we did not find a previous study comparing type 2 diabetes patients
receiving insulin medication and taking oral antidiabetics.

In our study, we aimed to compare patients who underwent coronary artery
bypass surgeries with type 2 diabetes patients receiving insulin
treatments and patients taking oral antidiabetics all with normal
creatinine values of microalbuminuria, which is one of the poor
prognostic factors.

According to the results we obtained there were no statistically
significant difference between the preoperative demographic data,
preoperative microalbuminuria levels and perioperative cross clamp
times, total pump times and bypass numbers of both groups.

When the postoperative durations of stay on the ventilator compared,
there was no statistically significant difference between the groups
although the durations were longer in the diabetic group receiving
insulin treatment. There was no statistically significant difference
between the amount of drainage. When the length of stay in intensive
care unit and hospital stays were compared, there was no statistically
significant difference, although the average of the diabetic group
receiving insulin treatment was high.

No postoperative early mortality observed in both patient groups.

Mediastinitis developed in one patient who was in the diabetic group
receiving insulin treatment. Mediastinitis is generally seen with a rate
of 1-4\%, and it is known that rates of non-healing wounds and
mediastinitis are higher in diabetic patients receiving insulin
treatment (30). In our study, the rate of mediastinitis was calculated
as 1.25\%. When only the group receiving insulin treatment was
considered, the rate was found as 2.38\%. When we evaluated this result,
we thought that diabetes treatment with insulin may have a facilitating
role for mediastinitis rather than microalbuminuria.

When the postoperative data are examined, it is seen that the most
important difference is on renal functions. The mean preoperative
creatine level of diabetic group taking oral antidiabetics was 0.88 \selectlanguage{ngerman}±
0.16, and the mean creatine level was 1.01 ± 0.18 on the postoperative
3rd day. The increase in between was found to be statistically
significant (P \textless{}0.001). The mean preoperative creatine levels
of diabetic group receiving insulin treatment were 0.93 ± 0.21, the mean
postoperative day 3 creatine levels were found to be 1.33 ± 0.46, and
the increase in creatine levels was also statistically significant (P
\textless{}0.001). These two data showed that there was a significant
increase in creatine levels after on-pump coronary artery bypass surgery
of the type 2 diabetes patients using insulin and taking oral
antidiabetics, with microalbuminuria.

When the preoperative creatinine values of both groups were compared,
there was no statistically significant difference. When the increases in
creatinine levels on the postoperative 3rd day were compared between the
groups, there was a much higher increase in the diabetic group using
insulin compared to the diabetic group taking oral antidiabetics, which
was statistically significant (P \textless{}0.001). Acute renal failure
developed in only one patient in the diabetic group using insulin who
returned to normal with the treatment, without any need for dialysis.
This shows us that creatine levels of diabetic patients receiving
insulin treatment with microalbuminuria have a significant increase when
compared to ones taking oral antidiabetics, and these patients even have
the risk of acute renal failure.

As the conclusion of this study, we think that the presence of
microalbuminuria in patients causes impairment in renal functions in the
early postoperative period of on-pump coronary artery bypass operations,
and this deterioration is much more severe in type 2 diabetes patients
receiving insulin treatment. In addition, we think that the surgery of
patients with microalbuminuria can be performed safely, since there is
no difference between the durations of stay on the ventilator, the
length of stay in intensive care unit and hospital stay, and the
impairment of kidney functions can be treated with an effective
intensive care treatment without the need for dialysis.

The number of patients included seems to be sufficient because only the
patient group with microalbuminuria was determined as the target for our
study however, we think that a larger patient group should be studied
and the results should be compared with another study including patients
with low ejection fraction.

\textbf{Disclosure statement}

No potential conflict of interest was reported by the authors.

\textbf{Funding}

This study received no specific grant from any funding agency in the
public, commercial, or not-for-profit sectors

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