Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365489
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas Based on Brachial Artery
Sponsor:
Golestan University of Medical sciences
Organization:
Golestan University of Medical sciences
Study Overview
Official Title:
Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas Based on Brachial Artery in Surgical Candidates Referred to Surgical Clinics in Gorgan in 1400
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
Arterio-Venous Fistula AVF is the most recommended vascular access for hemodialysis Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome In this study the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated
Detailed Description:
Chronic kidney disease CKD affects the structure and function of the kidneys Many of CKD patients are not suitable candidates for a kidney transplant so relying on some type of dyalisis is unavoidable
Hemodialysis is the most common type of Renal Replacement Therapy The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula AVF One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF
Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal it assures the surgeon that the distal circulation is sufficient
Summary of the project implementation method First the demographic questionnaire is completed for patients who meet the criteria for entering the study Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured Two weeks and three months later times of suture removal and fistula maturation assessment the measurements are repeated and their correlations with steal syndrome symptoms are recorded
The data will be analyzed in SPSS16 statistical software
Hemodialysis is the most common type of Renal Replacement Therapy The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula AVF One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF
Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal it assures the surgeon that the distal circulation is sufficient
Summary of the project implementation method First the demographic questionnaire is completed for patients who meet the criteria for entering the study Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured Two weeks and three months later times of suture removal and fistula maturation assessment the measurements are repeated and their correlations with steal syndrome symptoms are recorded
The data will be analyzed in SPSS16 statistical software
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