VARIANCE IN MICROBIOLOGY IN DOUBLE LUMEN CATHETERS RELATED SEPSIS IN

DIABETIC PATIENTS

INTRODUCTION

Catheter-related bloodstream infections (CRBSIs) are a significant concern in clinical

settings, particularly in diabetic patients, who are inherently at higher risk due to
compromised immunity and poor wound healing. Among the various types of catheters,
double-lumen catheters (DLCs) are commonly used for their utility in managing critical
conditions, including dialysis and parenteral nutrition. However, DLCs are also associated
with a higher propensity for microbial colonization and subsequent sepsis, making their
impact on patient outcomes. However, infection is one of the primary problems connected
to the use of the catheters with a considerable range in the occurrence. he variance in
microbiological profiles of pathogens associated with catheter-related sepsis in diabetic
populations is notable. Pathogens such as Staphylococcus aureus, Klebsiella pneumoniae,
and Pseudomonas aeruginosa often dominate, but emerging multidrug-resistant organisms
add complexity to management strategies. Understanding this microbiological diversity is
essential for targeted antimicrobial therapy and effective infection control measures.1, 2.

Diabetes, as a predisposing factor, exacerbates the risk of catheter-related sepsis due to

hyperglycemia-induced immune dysfunction, altered host-pathogen interactions, and
delayed responses to infections. The prevalence of DLC-related sepsis in diabetic patients
varies globally but shows an alarming upward trend, reflecting an urgent need for focused
research in this subgroup.3.The microbiological variance in DLC-related sepsis among
diabetic patients, focusing on prevalence and anticipated population impacts. By identifying
key pathogens and resistance patterns, the research seeks to guide clinicians in optimizing
prophylactic and therapeutic interventions. Moreover, understanding these variations could
support public health strategies to minimize infection risks and improve outcomes in this
vulnerable population. 4. Double-lumen catheterization now provides a safer and simpler
access for effective hemodialysis with high patient acceptability and a low complication
rate5. When long-term access is not available, the non-tunelled double lumen catheter
(DLC) becomes the catheter of choice6.

Weldetensae M K studied that The mean age was 39±17.9 years and the average duration of
catheter stay was 58 ±95 days. A hundred thirty-five (38.2%) CRBSIs were documented
with an incidence rate of 7.74 episodes per 1000 catheter days. The causative
microorganism was predominantly gram-negatives (57.6%). Duration of a catheter (AOR:
0.3; P < 0.001), previous CVC infection (AOR: 11.9; P < 0.001), high white blood cell count
(AOR: 0.31; P<0.001), urban residence (AOR: 1.92; P<0.05), and low hemoglobin levels
(AOR: 2.78; P < 0.05) were independently associated with catheter-related bloodstream
infections7. According to studies conducted in Algeria, the complication of bloodstream
infection or bacteremia following DLC insertion went up to 23.9% and 22%, respectively8.
More than 300.000 people in the Canada rely on hemodialysis, with the majority of them
caused by advanced renal disease9.10.11, 12
To the best of our knowledge, the bacteriological profile of DLC related sepsis in diabetic
patients, as well as the antibiograms of the isolates, have received little attention in
Pakistan. The majority of the provided data are from Intensive Care Unit (ICU) studies that
do not focus on diabetic patients. No study examined catheter-related infection and sepsis
in SLCs with double-lumen catheters (DLCs) of the same gauge and length. Therefore the
present study focused on the variance in microbiology in double lumen catheters related
sepsis in diabetic patients. The interplay between microbiology, catheter use, and diabetes
presents a pressing challenge. This study underscores the importance of tailoring infection
prevention and control strategies to address the unique needs of diabetic patients with
DLCs.

OBJECTIVE

Primary Objective:To determine the microbial variations in double-lumen catheter-related

bloodstream infections (CRBSIs) in diabetic patients.

Secondary Objectives:To identify the predominant microbial species causing sepsis in

double-lumen catheterized diabetic patients.

To evaluate the antibiotic resistance patterns in isolates from catheter-related infections.

To assess clinical outcomes associated with different microbial species and treatment
protocols.

OPERATIONAL DEFINITION

Double-Lumen Catheter-Related Sepsis (Dependent Variable):

Defined as bloodstream infection (BSI) in diabetic patients with a double-lumen catheter

where the same organism is isolated from the catheter tip and at least one peripheral blood
culture, with clinical signs of sepsis (fever >38°C, chills, or hypotension)

Microbial Variations: Refers to the differences in the types and proportions of

microorganisms (bacteria and fungi) isolated from catheter-related infections, such as
gram-positive bacteria, gram-negative bacteria, and fungi.

Diabetic Patients (Study Population): Patients diagnosed with diabetes mellitus (type 1 or
type 2) as per the American Diabetes Association (ADA) criteria.

Antibiotic Resistance (Secondary Variable): The percentage of isolates resistant to

commonly used antibiotics tested via susceptibility testing (e.g., Kirby-Bauer disk diffusion
or MIC).

Clinical Outcome (Dependent Variable): Defined by the resolution of sepsis, persistence of

infection, or mortality, assessed within 30 days of infection onset.

Positive catheter segment culture: More than 15 colonies of an organism recovered on semi-
quantitative culture of a portion of the catheter will indicate a positive culture.
Catheter-related infection: The recovery of more than 15 colonies of an organism from a
catheter segment associated with local infection at the puncture site will be considered as
catheter related infection. Local infection refers to presence of tenderness, erythema and
pus discharge.

Catheter related blood stream infections (CRBSI): A laboratory-confirmed bloodstream

infection (positive blood culture) in a patient with a central venous catheter, where no other
source of infection is identified, and clinical signs of infection improve after catheter
removal.

Catheter seeding: Secondary seeding of the catheter due to bacteremia from a distant focus
will be defined as catheter seeding.

Catheter-related sepsis: Isolation of the same organism in more than 15 colonies from a skin
swab, catheter segments or peripheral blood culture, presence of erythema and pus at the
puncture site and signs and symptoms of septicemia such as fever, chills, tachypnoea,
tachycardia, hypotension and altered sensorium which subsided on removal of the catheter.

MATERIALS AND METHODS

Study Design: Cross-sectional study

Settings: This study will be conducted in the Department of Internal Medicine, TCH
Peshawar.

Duration of Study: The minimum duration of the study will be six months from the date of
synopsis approval.

Sampling technique; Non-probability consecutive sampling technique

Sample Size: using WHO sample calculator

Confidence interval 95%

Margin of error 5%

anticipated population proportion=( Complication of bloodstream infection or bacteremia

following DLC insertion)7 =67.5%

Sample size (n) = 383

SAMPLING SELECTION:

Inclusion criteria:

Age ≥18–years

Either gender
dult patients (e.g., ≥18 years) with diabetes mellitus (Type 1 or Type 2).

Patients with double-lumen catheters inserted for at least 48 hours.

Clinical signs and symptoms suggestive of sepsis (e.g., fever >38°C, chills, or hypotension).

Confirmed catheter-related bloodstream infection (CRBSI) based on laboratory tests (blood

culture from catheter and peripheral vein, and/or catheter tip culture).

Exclusion Criteria;

Patients with non-catheter-related infections as the primary source of sepsis.

Immunocompromised patients (e.g., on chemotherapy, post-transplant).

Patients on long-term antifungal/antibiotic therapy before catheter insertion.

DATA COLLECTION PROCEDURE

This cross-sectional study will be conducted in the Department of Internal Medicine,

Tertiary Care Hospital Peshawar, Pakistan. Prior to study conduction, ethical approval will
be taken from the respective institutional research and ethical review committee. a total
number of 383 patients will be screened for DLC.The procedure will be explained to each
individual and informed consent will be taken. A double lumen catheter will be kept in place
for 7-10 days but will remove whenever infective complications will be suspected. The
catheters will be used for administering total parenteral nutrition, crystalloids, colloids,
blood products and drugs, and to measure central venous pressure using a transducer
system as well as to draw samples for routine investigations. All patients will receive
appropriate doses of crystalline penicillin, gentamycin and metronidazole on admission to
the ICU. The antibiotics will be changed after culture and sensitivity reports of specimens.
All the patients will require a change of antibiotics after 4-6 days' stay in the ICU. A separate
peripheral line will be used in all patients to inject antibiotics. A semi-quantitative culture
method will be used to identify positive catheter segment colonization by bacteria, catheter
related infection and sepsis. The catheter segments will be rolled back and forth in a blood
agar plate 3-4 times using a sterile pair of forceps. The catheters will be then removed and
inoculated into nutrient broth. The plate and broth will be incubated aerobically at 37°C and
examined the following day. Each isolate will be counted and identified using standard
bacteriological techniques. If the broth obtained will be turbid it will inoculated onto a
blood agar plate, incubated at 37°C overnight and the isolates will be identified.Outcome
will be measured in terms of Resolution of sepsis or persistence.Duration of hospital/ICU
stay.Mortality or survival.

DATA ANALYSIS
Data analysis will be done using SPSS version 27. Continuous data will be presented as
mean and SD or median and the interquartile range, and categorical data will be described
as frequencies and percentages. Quantitative variables Weight gain, blood pressure, HbA1c
levels (if diabetic)., birth weight, Apgar score, gestational age at birth, number of antenatal
visits, missed appointments. will be measurwed as Quantitative variables.Patient
satisfaction: Collected through surveys or Likert scales and themes of discussions:
Observational analysis of group dynamics. Content Analysis: to evaluate survey trends.
Mixed-Methods Analysis: Combining survey results will be measured as qualitative
variables. T-test, X2 test and analysis of variance (ANOVA) will be used as appropriate. The
microbiological variance of DLC-related sepsis will be stratified for infection, age, gender,
diabetes mellitus, hypertension, body mass index, previous history of DLC for hemodialysis,
previous history of bloodstream infection or bacteremia, site of insertion, DLC used, and
duration of catheter use. Post-stratification chi-square test will be used by taking 95%
confidence interval and 5% level of significance.

Performa:

Topic;Study on variance in microbiology of double-lumen catheters (dlcs) in diabetic

patients with sepsis

Section 1: Patient Demographics and Clinical Background

Patient ID/Code:

Age (years):

Sex: ☐ Male ☐ Female

Body Mass Index (BMI): ___ (kg/m²)

Diabetes Duration: ___ (years)

HbA1c Level: ___ (%)

Comorbidities (e.g., hypertension, CKD):

☐ Yes ☐ No (If yes, specify: ___________)

Section 2: Catheter Details

Catheter Insertion Date: //____

Catheter Duration: ___ days

Catheter Site: ☐ Jugular ☐ Subclavian ☐ Femoral

Indication for Catheterization:
☐ Dialysis ☐ Total Parenteral Nutrition (TPN) ☐ Other (specify: ________)

Previous Catheterization History: ☐ Yes ☐ No

Section 3: Infection Details

Date of Sepsis Diagnosis: //____

Signs of Infection:
☐ Fever ☐ Chills ☐ Erythema at Site ☐ Purulent Discharge
☐ Hypotension ☐ Tachycardia ☐ Other: _____________

Blood Culture Results (paired blood and catheter tip):

Microbial Species Isolated: ___________

Colony-Forming Units (CFUs): ___

Section 4: Microbiology Findings

Type of Organism:
☐ Gram-Positive ☐ Gram-Negative ☐ Fungal

Predominant Species Identified:

☐ Staphylococcus aureus ☐ Coagulase-negative Staphylococcus
☐ Escherichia coli ☐ Klebsiella pneumoniae ☐ Candida spp.
☐ Other: ______________

Antibiotic Sensitivity Testing:

Resistant to: _________________

Sensitive to: _________________

Multidrug-Resistant (MDR) Pathogens: ☐ Yes ☐ No

Section 5: Treatment and Outcomes

Empiric Antibiotic Therapy Started: ☐ Yes ☐ No

Agent Used: ______________

Definitive Therapy (Post-Sensitivity Testing):

Agent Used: ______________

Duration: ___ days

Removal of Catheter: ☐ Yes ☐ No

Clinical Outcome:
☐ Recovered ☐ Persistent Sepsis ☐ Mortality

Complications Observed:
☐ Acute Kidney Injury (AKI) ☐ Multiorgan Dysfunction Syndrome (MODS)
☐ Other: ______________

Section 6: Study-Specific Data

Microbial Diversity Observed:

Count of distinct species isolated: ___

Antibiotic Resistance Patterns:

Resistance Rate (%) to major drug classes (e.g., β-lactams, carbapenems): __

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