Clinical trial NCT04386954: Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
Official title: To Study Patency Rates and Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: Arteriovenous Fistula, dialysis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of end stage renal disease

Brief summary: End stage renal disease cases has increased significantly in the last decade. There are various treatment modalities which are available for the ESRD patients. Treatment options includes haemodialysis, peritoneal dialysis and renal transplant. Renal transplant is considered as the best treatment for these patients. However, in developing countries like india feasibility of renal transplant is questionable due to the limited donors and logistic reasons. Therefore haemodialysis remains the most popular modality of treatment for such patients. Creation of vascular access is a necessary maneuver for hemodialysis but creation and maintenance of a well-functioning vascular access remains the most challenging problems for hemodialysis therapy There are various other reasons for the non maturation of arteriovenous fistula and these include increased age, diabetes mellitus, hypertension, smoking, coronary artery disease, obesity, decreased diameter of the cephalic vein and radial artery, atherosclerosis, and surgeon factor. As per our literature search , these factors has not been well studied in Indian population. Hence the aim of the present study is to identify the various risk factors for the primary failure of forearm and wrist arteriovenous fistulas for hemodialysis in patients with chronic renal failure in Indian population

Detailed description: Pre-operatively all patients were advised soft ball arm exercise. Patients were instructed not to use the concerned arm for blood sampling. The morning dose of antihypertensive was skipped if the patient mean arterial blood pressure was less than 100 mm Hg. Modified Allens test was done pre operative to check for the patency of the palmar arch. Preoperative Doppler of the concerned limb was done one day prior to the procedure by the consultant radiologist. The ulnar artery, radial artery, and cephalic vein diameter were measured at the wrist and the forearm. They were imaged in both transverse and sagittal planes at the levels of venous stenosis or thrombosis and a venogram was considered. On the day of surgery, patient were advised to take light breakfast in the morning prior to the procedure. Patient were shifted inside the operation theatre and all American society anaesthesiologist standard monitors were attached. This included pulse oxymeter, non invasive blood pressure and electrocardiogram. Patients lie supine on the operating table and the arm selected for fistula creation was abducted to an angle of 90 degree and kept on an arm rest.

Under all aseptic precaution 10 ml of local anaesthetic agent (5ml 2% Lidocaine + 5 ml Normal saline) was injected just proximal to wrist joint. After waiting for 5 minutes and confirmimg its effect, a 2 cm skin incision was made in between the radial artery and cephalic vein in the distal forearm. First of all, cephalic vein was dissected free from the surrounding structures. The S shaped retractors were used for the proper exposure. All vein tributaries were ligated with 4-0 silk. Vein at the distal end of the incision was ligated and divided. A 20 G cannula was inserted and 10 ml of heparinized saline (1 unit ml-1) was injected into the cephalic vein. After this a 5 F infant feeding tube was inserted into the vein and another 10 ml of heparinised saline was injected. Radial artery is then identified and mobilized from the surrounding structures. Around one and half cm of radial artery is exposed. Bull dog clamps were applied both proximally and distally to occlude the blood flow. Then using 11 number scalpel blade an arteriotomy of approximately 1 cm was done. Similarly veinotomy of around 1.3 cm was done for cephalic vein using the potts scissor. Then end to side anastomosis was done using continuous 7-0 prolene sutures. Posterior wall was done first, followed by the anterior wall. After completing the procedure and achieving complete haemostatsis, fistula was palpated for the presence of immediate thrill. Tablet amoxicillin 500 mg with clavulanic acid 125 mg was given to all patients for 5 days and after each dialysis. Soft ball arm exercise was also advised till the fistula matures. Immediate surgical complications were noted.

Eligibility criteria: Inclusion Criteria:

* all patients who present to the institute for primary renal vascular access for hemodialysis

Exclusion Criteria:

* patients with previous failed attempts for vascular access

Primary outcomes:
measure: The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula.
timeFrame: 6 months
Secondary outcomes:
measure: The correlation of age, sex, diabetes melitus and hypertension with success of arteriovenous fistula.
timeFrame: 6 months
measure: Success rate of av fistula
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Ilbs
state: Delhi
Study officials:
affiliation: ilbs
name: anil sharma, mch
role: PRINCIPAL_INVESTIGATOR
References:
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