Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746742
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2021-01-10
Brief Title:
Prosthetic Femoral Access for Haemodialysis
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Tunneled Femoral Catheter Versus Femoro-femoral Arteriovenous Graft as a Lower-Extremity Hemodialysis Vascular Access A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the outcomes of tunneled femoral catheter and femoro-femoral arteriovenous graft as a bailout procedure for hemodialysis in chronic kidney disease patients with exhausted upper-extremity and chest-wall vascular accesses regarding survival rate complications and quality of life
Detailed Description:
Aim of the Work
The aim of this work is to compare the outcomes of tunneled femoral catheter TFC and femoro-femoral AVG as regards survival complication and quality of life as bailout procedure for hemodialysis in CRF patient with exhausted upper limb extremity and chest wall vascular accesses
Patients and Methods
Study Design and setting
This is a single-centre prospective randomized controlled trial that will be conducted in The Vascular Surgery Department Mansoura University Hospital during the period from November 2020 to November 2022 It will be submitted for approval by Institutional Review Board faculty of medicine Mansoura University
Eligibility criteria
The study population will be on patients referred to the vascular surgery department suffering from end-stage renal disease ESRD with exhausted upper-extremity and chest wall vascular accesses
Inclusion
In this study The investigator will include all ESRD patients belonging to the age group 15 years who complain of exhaustion of all upper extremity vascular accesses
Exclusion
The investigators will exclude patients with previous history or evident deep venous thrombosis DVT varicose veins femoral vein stenosis arterial insufficiency severe groin or limb infection
Preoperative assessment
A comprehensive history will be taken from the patients with regard to patients demographics underlying medical conditions duration since the starting of haemodialysis previous trials of vascular access history of DVT and arterial insufficiency
Also patients will be examined to exclude any possibility for upper extremity vascular access A meticulous examination of both lower limbs is done to assess the possibility of infection signs of venous stenosis or arterial inefficiency including palpation of accessible lower limb arteries
Routine laboratory investigations are carried out for all patients including complete blood count liver function tests renal function tests arterial blood gases bleeding and coagulation profiles fasting and 2hr-postprandial serum glucose level lipid profile and glycosylated hemoglobin HbA1c
Further investigations include duplex ultrasonography US assessing for both superficial and deep venous system of the both lower limb Bilateral lower limb arterial duplex is done to exclude any arterial disease Also a preoperative venous mapping of lower limb veins is mandatory
Procedures and Postoperative care
Procedures
1 Tunneled femoral catheter a standard technique is adopted according to the study performed by Herzallah using long tunneled catheter
2 Femoral artery-femoral arteriovenous graft a straight or loop configuration Ponikvar
Endpoints and Follow-up
Every patient will be followed every week until first month then every 3 months until the end of the first years so that the hemodynamic improvement will be assessed
Primary outcome
Evaluation of primary patency rates within the study follow-up time frame
In case of TFC Normally an extracorporeal blood flow should be about 300 mlmin based on this the catheter dysfunction can be defined by the first occurrence of either peak blood flow of 200 ml per minute or less for 30 minutes during a dialysis treatment mean blood flow of 250 ml per minute or less during two consecutive dialysis treatments or inability to initiate dialysis owing to inadequate blood flow after attempts to restore patency have been attempted
In case of AVG stenosis 50 of the prosthesis diameter or complete occlusion is considered significant This can be assessed by duplex ultrasonography every six months or when the patency is questionable
The patency rates will be determined according to the reporting standards set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses
Secondary outcome
The secondary patency the patency rates will be determined according to the reporting standards set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses
The special adverse events complicating lower-extremity hemodialysis access The severity of arteriovenous access complications will be graded according to the Reporting Standards document Complications are defined according Clavien-Dindo
Patient satisfaction will be assessed using a validated tool the vascular access score questionnaire at 6 and 12 months postoperatively
Besides operative time hospital stay and survival rate will be assessed
Sample size calculation
Based on the average of the primary outcome primary patency a previous study showed that the mean rate in AVGs at 6 months was 53 while another study showed that the mean rate in TFC at six months was 14
Using sample size calculation software wwwclincalccom a minimum of 44 patients will be needed to achieve a study power of 80 with alpha set at 5 Estimating a drop-out rate and loss to follow-up of 10 a total of 48 patients will be ultimately included
Random sequence generation and blinding
Patients will be randomized to one of two groups group I Tunneled femoral catheter and group II Femoral artery-femoral vein graft
Randomization will be undertaken by the sealed envelope method using randomization software Neither the operating surgeons nor the assessors during the follow-up will be aware about patients participation in the study
The aim of this work is to compare the outcomes of tunneled femoral catheter TFC and femoro-femoral AVG as regards survival complication and quality of life as bailout procedure for hemodialysis in CRF patient with exhausted upper limb extremity and chest wall vascular accesses
Patients and Methods
Study Design and setting
This is a single-centre prospective randomized controlled trial that will be conducted in The Vascular Surgery Department Mansoura University Hospital during the period from November 2020 to November 2022 It will be submitted for approval by Institutional Review Board faculty of medicine Mansoura University
Eligibility criteria
The study population will be on patients referred to the vascular surgery department suffering from end-stage renal disease ESRD with exhausted upper-extremity and chest wall vascular accesses
Inclusion
In this study The investigator will include all ESRD patients belonging to the age group 15 years who complain of exhaustion of all upper extremity vascular accesses
Exclusion
The investigators will exclude patients with previous history or evident deep venous thrombosis DVT varicose veins femoral vein stenosis arterial insufficiency severe groin or limb infection
Preoperative assessment
A comprehensive history will be taken from the patients with regard to patients demographics underlying medical conditions duration since the starting of haemodialysis previous trials of vascular access history of DVT and arterial insufficiency
Also patients will be examined to exclude any possibility for upper extremity vascular access A meticulous examination of both lower limbs is done to assess the possibility of infection signs of venous stenosis or arterial inefficiency including palpation of accessible lower limb arteries
Routine laboratory investigations are carried out for all patients including complete blood count liver function tests renal function tests arterial blood gases bleeding and coagulation profiles fasting and 2hr-postprandial serum glucose level lipid profile and glycosylated hemoglobin HbA1c
Further investigations include duplex ultrasonography US assessing for both superficial and deep venous system of the both lower limb Bilateral lower limb arterial duplex is done to exclude any arterial disease Also a preoperative venous mapping of lower limb veins is mandatory
Procedures and Postoperative care
Procedures
1 Tunneled femoral catheter a standard technique is adopted according to the study performed by Herzallah using long tunneled catheter
2 Femoral artery-femoral arteriovenous graft a straight or loop configuration Ponikvar
Endpoints and Follow-up
Every patient will be followed every week until first month then every 3 months until the end of the first years so that the hemodynamic improvement will be assessed
Primary outcome
Evaluation of primary patency rates within the study follow-up time frame
In case of TFC Normally an extracorporeal blood flow should be about 300 mlmin based on this the catheter dysfunction can be defined by the first occurrence of either peak blood flow of 200 ml per minute or less for 30 minutes during a dialysis treatment mean blood flow of 250 ml per minute or less during two consecutive dialysis treatments or inability to initiate dialysis owing to inadequate blood flow after attempts to restore patency have been attempted
In case of AVG stenosis 50 of the prosthesis diameter or complete occlusion is considered significant This can be assessed by duplex ultrasonography every six months or when the patency is questionable
The patency rates will be determined according to the reporting standards set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses
Secondary outcome
The secondary patency the patency rates will be determined according to the reporting standards set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses
The special adverse events complicating lower-extremity hemodialysis access The severity of arteriovenous access complications will be graded according to the Reporting Standards document Complications are defined according Clavien-Dindo
Patient satisfaction will be assessed using a validated tool the vascular access score questionnaire at 6 and 12 months postoperatively
Besides operative time hospital stay and survival rate will be assessed
Sample size calculation
Based on the average of the primary outcome primary patency a previous study showed that the mean rate in AVGs at 6 months was 53 while another study showed that the mean rate in TFC at six months was 14
Using sample size calculation software wwwclincalccom a minimum of 44 patients will be needed to achieve a study power of 80 with alpha set at 5 Estimating a drop-out rate and loss to follow-up of 10 a total of 48 patients will be ultimately included
Random sequence generation and blinding
Patients will be randomized to one of two groups group I Tunneled femoral catheter and group II Femoral artery-femoral vein graft
Randomization will be undertaken by the sealed envelope method using randomization software Neither the operating surgeons nor the assessors during the follow-up will be aware about patients participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None