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Chronic kidney disease is becoming a worldwide public health problem and each year an estimated 120 Filipinos per million population develop kidney failure. This means that about 10,000 Filipinos need to replace their kidney function each year. Patient's who seek consult with CKD mostly presents with signs and symptoms of uremia which eventually requires emergency hemodialysis. Temporary hemodialysis catheters are necessary in patients with uremia so that emergent hemodialysis will be done. However, there are several complications as to the insertion of these catheters, and catheter related bacteremia (CRB) is one major complication. According to different studies, microorganisms become metabolically active and viable as early as 24 hours from the time of the catheter insertion and the mean catheter duration before the onset of CRB was 19.9 days. Ideally, temporary catheter should be replaced with the permanent AV fistula after 2 weeks, but in our setting since most of the patients have financial difficulties temporary shunts are the usual access in hemodialysis. The standard of care in maintaining the accessibility of shunts in our setting is by using the heparin lock. Antibiotic heparin lock is basically used as treatment when bacteremia due to catheter insertion already ensues with concomitant intravenous antibiotics. The significance of this study will determine if the instillation of an antibiotic lock into the catheter lumen after dialysis sessions will lower rate of bacteremia.
Review of Related Literature:
Chronic kidney disease is long-standing, progressive deterioration of renal function. Symptoms develop slowly and include anorexia, nausea, vomiting, fatigue, pruritus, decreased mental acuity, muscle twitches and cramps, water retention, undernutrition, GI ulceration and bleeding, peripheral neuropathies, and seizures.
The Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF) defines chronic kidney disease as either kidney damage or a decreased kidney glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2 for 3 or more months. Whatever the underlying etiology, the destruction of renal mass with irreversible sclerosis and loss of nephrons leads to a progressive decline in GFR.
K/DOQI published a classification of the stages of chronic kidney disease1, as follows:
Stage 1: Kidney damage with normal or increased GFR (>90 mL/min/1.73 m2)
Stage 2: Mild reduction in GFR (60-89 mL/min/1.73 m2)
Stage 3: Moderate reduction in GFR (30-59 mL/min/1.73 m2)
Stage 4: Severe reduction in GFR (15-29 mL/min/1.73 m2)
Stage 5: Kidney failure (GFR <15 mL/min/1.73 m2 or dialysis)
Most patients with CKD who came for consult at the emergency room presents with uremia and temporary hemodialysis catheters are necessary for emergent hemodialysis, but complications associated with these catheters represent one of the most important sources of morbidity among CKD patients. Early complications (puncture site hemorrhage, hematoma formation, artery puncture) were infrequent, without clinical sequelae. The main late complication was catheter related bacteremia (CRB). The mean catheter duration before the onset of CRB was 19.92. When catheter bacteraemia ensues K/DOQI guidelines recommend treating catheter-related bacteraemia with systemic antibiotics, as well as catheter replacement3. This approach produced a bacteriologic and clinical cure in about two-thirds of cases, thereby obviating the need for catheter replacement4. Several studies were made on the different antibiotics on the treatment of CRB. These antibiotics included gentamycin, vancomycin, ceftazidime, cefazolin and others in combination5. One study compared 3 groups of patients on dialysis comparing application of polymyxin and bacitracin ointment to the skin exit site for 2 weeks at the end of the dialysis session while the catheter was filled with pure heparin 5,000 U/ml, while the other group received catheter filling solution at the end of each dialysis session by adding 0.75 ml of gentamicin (40 mg/ml), drawn with an insulin syringe, inside a 5-ml vial of heparin, this low dose of gentamicin as an antibiotic lock has been shown to be effective and non-toxic 6,7 ,and the last group received both application of antibiotic ointment and the gentamicin/heparin solution. Results showed that the first had a higher rate of CRB, favoring the superiority of antimicrobial lock over exit site prophylaxis in catheters. Concerning the locked catheters, the number of CRB events in lock + ointment is superior but not significantly different from lock alone8. There were also studies comparing the location of catheter sites. One study showed that the incidence of bacteremia was 5.4% in internal jugular vein and 10.7% in femoral vein9.
With these different studies, it has showed that antibiotic heparin locks are usually used when there was already onset of bacteremia with systemic antibiotic as per K/DOQI guidelines. Though there were already studies using antibiotic locks such as gentamicin, cefazolin with gentamicin, minocycline, or cefotaxime10-14, 1 used taurolidine15 and 1 used 30% citrate16 and each of these studies revealed a dramatically lower frequency of catheter-related bacteremia in patients randomized to an antimicrobial lock, as compared with those receiving a conventional heparin lock, these studies were conducted at Birmingham, Alabama. There is still no study done on the prophylactic antibiotic heplock in our institution in which these temporary catheter are the usual access in hemodialysis for more than 2 weeks.
Will the incidence of catheter related bacteremia on patients undergoing hemodialysis decreases when using antibiotic heparin lock as compared with the standard heparin lock?
Significance of the Study:
The use of antibiotic heparin lock is usually used together with systemic antibiotic when there is presence of ongoing infection particularly catheter related. The significance of this study will determine if the instillation of an antibiotic lock into the catheter lumen after dialysis sessions will lower rate of catheter related bacteremia.
To determine the incidence of catheter-related bacteremia of patients on hemodialysis using prophylactic antibiotic lock vs heparin lock.
To determine the different factors as to age, co-morbidities, onset of uremia and catheter location that might have contributed to the incidence of bacteremia.
To identify the risk factors that might contribute to the increasing incidence of catheter related bacteremia.
To identify the most common organisms that will cause catheter related bacteremia.
Definition of Terms:
Catheter Related Bacteremia
isolation of organism in blood cultures drawn from the peripheral blood in a symptomatic patient with no other apparent source of infection
Chronic Kidney Disease
kidney damage or a decreased kidney glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2 for 3 or more months
Glomerular Filtration Rate (GFR)
the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time.
accumulation in the blood of constituents normally eliminated in the urine that produces a severe toxic condition and usually occurs in severe kidney disease
the site were the temporary catheter will be inserted
Randomized single blind controlled trial
This study is conducted at the dialysis unit of a tertiary hospital in Davao City from March 2010 - September 2010.
Patients ages 20 - 65 years old.
Patients diagnosed with Chronic Kidney Disease and require hemodialysis.
Patients who consented for temporary IJ shunt insertion.
Patients will be on hemodialysis for two weeks preferentially on a twice a week basis.
Patients who have infection prior to the insertion of IJ Shunts.
Patients who are on antibiotic treatment during admission and before the insertion of IJ shunts.
Patients who are intubated.
Patients who are allergic to gentamicin.
Sampling procedure will be a simple random sampling type in which each sample will have an equal probability when drawn during each selection.
Interventions and Comparisons:
At the end of each dialysis session one group will be on antibiotic lock (gentamicin) which will be 0.75 ml of gentamicin (40 mg/ml), drawn with an insulin syringe, inside a 5-ml vial of heparin which shown to be effective and non-toxic, and the other group will be on placebo which is the standard heparin lock. The catheter exit site will be cleaned with a topical iodine solution at the initiation and termination of each dialysis session, and will be covered with dry sterile gauze during the interdialytic period. Strict sterile technique will be imposed on the care of catheter sites. Patients will be monitored and will note if there will be onset of fever on the one week and 2 week period. Potential sources of infection such as cough, dysuria, foot infection, diarrhea and the like will be identified and in the absence of evidence for an alternate source of infection, it will be presumed that the source of infection arose from the dialysis catheter. Blood cultures at the peripheral site with strict sterile technique will be taken at the end of a 72 hrs, 1 week, two 2 week period of all qualified subjects. Mean number of patients with bacteremia on placebo (heparin lock) will be compared on the mean number of patients with bacteremia on antibiotic lock.
Qualified participants will be randomized into two groups. One group will be on the placebo group (standard heparin lock) and the other group will be on the treatment group (gentamicin heparin lock). Distribution of demographic profiles will be equally group
Patients who will be admitted due to CKD and who will be requiring emergent hemodialysis. The following Baseline laboratory test will be done to detect any concomitant infection which includes complete blood count, chest radiograph and urinalysis. These patients will be followed up after baseline, 72 hrs, 1 week and 2 weeks. Blood culture from peripheral vein will be taken every after follow up.
Primary Outcome Measure:
Presence of Catheter Related Bacteremia after a 2 week period of dialysis which is defined as isolation of organism in blood cultures drawn from the peripheral blood in a symptomatic patient with no other apparent source of infection.
Secondary Outcome Measure
Standard care of the exit site of the catheter during interdialytic period.
Immediate cause of the CKD.
Site of the IJ shunt.
Regularity of the dialysis session.
Sample Size Computation:
As of this moment since there are still 31 patients who are qualified of this study the sample size computed with this population with a 95% confidence interval is 1.
Data Handling and Analysis:
The principal investigator will ensure that all data collected in the study are provided to the hospital. He/She ensures the accuracy, completeness, legibility and timeliness of the data recorded. Data validation will also be performed to ensure quality data quality.
All qualified patients will sign informed consent and will be educated as to the objectives of the study. As to the treatment group the lowest effective dose that will not cause any harm will be the treatment dose and handlers will also be educated as to the proper care on the exit sites of the catheters. All patients will be properly monitored during the 2 week treatment period.
Table 1. Demographic Profile
HPN - Hypertension
DM - Dibetes Mellitus
Site of IJ Shunt
Table 2. Comparison of Means