End Stage Renal DiseaseNCT04386954
Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
An observational study of End Stage Renal Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- observational study
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 14 Apr 2018to 10 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of end stage renal disease
Who may be able to join
- all patients who present to the institute for primary renal vascular access for hemodialysis
Who cannot join
- patients with previous failed attempts for vascular access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Study Patency Rates and Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
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
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- observational study
- Keywords
- Arteriovenous Fistula, dialysis
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyProcedure or surgery
observation study
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula.
The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula at 1 week, 1 month and 6 months.
Measured: 6 months
Secondary outcomes (2)
The correlation of age, sex, diabetes melitus and hypertension with success of arteriovenous fistula.
The correlation of age, sex, diabetes melitus and hypertension with success of arteriovenous fistula at 1 week, 1 month and 6 months.
Measured: 6 months
Success rate of av fistula
Success rate of av fistula at 1 week, 1 month and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start14 Apr 2018
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Sharma, Institute of Liver and Biliary Sciences, India
- Investigators
- anil sharma, mch, Principal investigator, ilbs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386954
- Sponsor's protocol ID
- ILBSIndiag
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Swai J, Zhao X, Noube JR, Ming G. Systematic review and meta-analysis of clinical outcomes comparison between different initial dialysis modalities in end-stage renal disease patients due to lupus nephritis prior to renal transplantation. BMC Nephrol. 2020 May 1;21(1):156. doi: 10.1186/s12882-020-01811-y.
PubMed 32357924Haller MC, Kainz A, Baer H, Oberbauer R. Dialysis Vintage and Outcomes after Kidney Transplantation: A Retrospective Cohort Study. Clin J Am Soc Nephrol. 2017 Jan 6;12(1):122-130. doi: 10.2215/CJN.04120416. Epub 2016 Nov 28.
PubMed 27895135Siddiqui MA, Ashraff S, Santos D, Rush R, Carline T, Raza Z. Predictive parameters of arteriovenous fistula maturation in patients with end-stage renal disease. Kidney Res Clin Pract. 2018 Sep;37(3):277-286. doi: 10.23876/j.krcp.2018.37.3.277. Epub 2018 Sep 30.
PubMed 30254852Hall RK, Myers ER, Rosas SE, O'Hare AM, Colon-Emeric CS. Choice of Hemodialysis Access in Older Adults: A Cost-Effectiveness Analysis. Clin J Am Soc Nephrol. 2017 Jun 7;12(6):947-954. doi: 10.2215/CJN.11631116. Epub 2017 May 18.
PubMed 28522655Robbin ML, Greene T, Cheung AK, Allon M, Berceli SA, Kaufman JS, Allen M, Imrey PB, Radeva MK, Shiu YT, Umphrey HR, Young CJ; Hemodialysis Fistula Maturation Study Group. Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology. 2016 May;279(2):620-9. doi: 10.1148/radiol.2015150385. Epub 2015 Dec 22.
PubMed 26694050Glass C, Johansson M, DiGragio W, Illig KA. A Meta-analysis of Preoperative Duplex Ultrasound Vessel Diameters for Successful Radiocephalic Fistula Placement. J Vasc Ultrasound. 2009 Jun 1;33(2):65-8.
Hou G, Yan Y, Li G, Hou Y, Sun X, Yin N, Feng G. Preoperative cephalic vein diameter and diabetes do not limit the choice of wrist radio-cephalic arteriovenous fistula. J Vasc Access. 2020 May;21(3):366-371. doi: 10.1177/1129729819879320. Epub 2019 Oct 3.
PubMed 31580187Weale AR, Bevis P, Neary WD, Boyes S, Morgan JD, Lear PA, Mitchell DC. Radiocephalic and brachiocephalic arteriovenous fistula outcomes in the elderly. J Vasc Surg. 2008 Jan;47(1):144-50. doi: 10.1016/j.jvs.2007.09.046.
PubMed 18178467Misskey J, Faulds J, Sidhu R, Baxter K, Gagnon J, Hsiang Y. An age-based comparison of fistula location, patency, and maturation for elderly renal failure patients. J Vasc Surg. 2018 May;67(5):1491-1500. doi: 10.1016/j.jvs.2017.08.080. Epub 2017 Dec 8.
PubMed 29224945Dunn J, Herscu G, Woo K. Factors influencing maturation time of native arteriovenous fistulas. Ann Vasc Surg. 2015;29(4):704-7. doi: 10.1016/j.avsg.2014.11.026. Epub 2015 Feb 26.
PubMed 25728334
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study Patency Rates and Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT04386954
- Acronym / sponsor ID
- ILBSIndiag
- Conditions
- End Stage Renal Disease
- Keywords
- Arteriovenous Fistula, dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 14 Apr 2018 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of end stage renal disease
Key inclusion criteria (1 listed)
- all patients who present to the institute for primary renal vascular access for hemodialysis
Key exclusion criteria (1 listed)
- patients with previous failed attempts for vascular access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservation study | Procedure or surgery | – |
Primary outcome
The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula.
Time frame: 6 months
The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula at 1 week, 1 month and 6 months.
2 secondary outcomes
The correlation of age, sex, diabetes melitus and hypertension with success of arteriovenous fistula.
Time frame: 6 months
Success rate of av fistula
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Background: PubMed 32357924Swai J, Zhao X, Noube JR, Ming G. Systematic review and meta-analysis of clinical outcomes comparison between different initial dialysis modalities in end-stage renal disease patients due to lupus nephritis prior to renal transplantation. BMC Nephrol. 2020 May 1;21(1):156. doi: 10.1186/s12882-020-01811-y.
- Background: PubMed 27895135Haller MC, Kainz A, Baer H, Oberbauer R. Dialysis Vintage and Outcomes after Kidney Transplantation: A Retrospective Cohort Study. Clin J Am Soc Nephrol. 2017 Jan 6;12(1):122-130. doi: 10.2215/CJN.04120416. Epub 2016 Nov 28.
- Background: PubMed 30254852Siddiqui MA, Ashraff S, Santos D, Rush R, Carline T, Raza Z. Predictive parameters of arteriovenous fistula maturation in patients with end-stage renal disease. Kidney Res Clin Pract. 2018 Sep;37(3):277-286. doi: 10.23876/j.krcp.2018.37.3.277. Epub 2018 Sep 30.
- Results publication: PubMed 28522655Hall RK, Myers ER, Rosas SE, O'Hare AM, Colon-Emeric CS. Choice of Hemodialysis Access in Older Adults: A Cost-Effectiveness Analysis. Clin J Am Soc Nephrol. 2017 Jun 7;12(6):947-954. doi: 10.2215/CJN.11631116. Epub 2017 May 18.
- Results publication: PubMed 26694050Robbin ML, Greene T, Cheung AK, Allon M, Berceli SA, Kaufman JS, Allen M, Imrey PB, Radeva MK, Shiu YT, Umphrey HR, Young CJ; Hemodialysis Fistula Maturation Study Group. Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology. 2016 May;279(2):620-9. doi: 10.1148/radiol.2015150385. Epub 2015 Dec 22.
- Results publicationGlass C, Johansson M, DiGragio W, Illig KA. A Meta-analysis of Preoperative Duplex Ultrasound Vessel Diameters for Successful Radiocephalic Fistula Placement. J Vasc Ultrasound. 2009 Jun 1;33(2):65-8.
- Results publication: PubMed 31580187Hou G, Yan Y, Li G, Hou Y, Sun X, Yin N, Feng G. Preoperative cephalic vein diameter and diabetes do not limit the choice of wrist radio-cephalic arteriovenous fistula. J Vasc Access. 2020 May;21(3):366-371. doi: 10.1177/1129729819879320. Epub 2019 Oct 3.
- Results publication: PubMed 18178467Weale AR, Bevis P, Neary WD, Boyes S, Morgan JD, Lear PA, Mitchell DC. Radiocephalic and brachiocephalic arteriovenous fistula outcomes in the elderly. J Vasc Surg. 2008 Jan;47(1):144-50. doi: 10.1016/j.jvs.2007.09.046.
- Results publication: PubMed 29224945Misskey J, Faulds J, Sidhu R, Baxter K, Gagnon J, Hsiang Y. An age-based comparison of fistula location, patency, and maturation for elderly renal failure patients. J Vasc Surg. 2018 May;67(5):1491-1500. doi: 10.1016/j.jvs.2017.08.080. Epub 2017 Dec 8.
- Results publication: PubMed 25728334Dunn J, Herscu G, Woo K. Factors influencing maturation time of native arteriovenous fistulas. Ann Vasc Surg. 2015;29(4):704-7. doi: 10.1016/j.avsg.2014.11.026. Epub 2015 Feb 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anil sharma, mch principal investigator
ilbs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation of cephalic vein and radial artery diameter with success of arteriovenous fistula. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386954, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.