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Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136859
Recruitment Status : Not yet recruiting
First Posted : November 29, 2021
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

End-stage renal disease patients needs a functional vascular access to receive hemodialysis and prolong their lives. Arteriovenous fistula (AVF) is priority consideration for hemodialysis, which is a connecting a superficial vein to a nearby artery and allowing this vein to enlarge and increase in internal diameter under arterial circulation. Unfortunately, 30-50% of fistulae fail to mature. Vascular calcification and stenosis were considered for early failure. The perivascular fat of artery can be predicted successful AVF maturation. However, Few previous studies have compared AVF maturation between perivascular the fat of cephalic vein or removal during the AVF surgery. This study evaluated whether the effect of AVF inflammation and preexisting vascular fibrosis is associated to perivascular the fat of cephalic vein. Investigators will also verify inflammation by analysis of blood and tissue samples, the association of pre-existing fibrosis, and the clinical correlation with AVF early failure.

This study will enroll patients with chronic kidney disease stage 5 and stage 6 who will need maintenance-hemodialysis (HD) from Nov 2021 to Dec 2022. Investigators will use the preoperative ultrasound assessment tool to confirm the feasibility of the arm vessels for the creation of a native AVF. As a prospective randomized controlled trial of perivascular fat preservation or removal during the AVF surgery, a study assistant will help the randomization and explain the informed consent to the patient . The subjects are randomly split into two groups: the experimental group will have the perivascular fat of the target cephalic vein preserved the control group will have the fat removed before the AVF anastomosis. The survey will enroll 100 adult patients and categorize them into groups according to each AVF maturation, JAS, or FTM (see definition below) by 3 - 12 after the surgery.


Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Procedure: preserve Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: preserve
preserve the perivascular fat of the target cephalic vein
Procedure: preserve
preserve the perivascular fat of the target cephalic vein

No Intervention: remove
remove from perivascular fat of the target cephalic vein



Primary Outcome Measures :
  1. The success by ultrasound parameters. [ Time Frame: 3 months after surgery ]
    Investigators propose an objective ultrasound scoring system(A hemodialysis arteriovenous fistula maturity score based on the following three objective ultrasonic measurements). Higher scores indicating more mature. Give a summary score range from 0 to 9 points., and of which a total of score 4 or more is considered as HDAVF maturation.

  2. Definition of delay maturation [ Time Frame: 3 months after surgery ]
    The subject HDAVF is clinically un-feasible for use for HD within 3 months and/or the A hemodialysis arteriovenous fistula maturity score based on the following three objective ultrasonic measurements is less than 4.


Secondary Outcome Measures :
  1. The clinical risk factors of " A hemodialysis arteriovenous fistula maturity score based on the following three objective ultrasonic measurements" less than 4. [ Time Frame: 3 months after surgery ]
    infection, bleeding, stroke, MI, deep vein thrombosis,peripheral arterial occlusion disease, died



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 20 and older adult patients.
  2. preoperatively clinical and ultrasound assessment of the arm vessels are visible for the creation of a native HDAVF that include:the augmented diameters of the veins is > 2.0 mm and the diameter of the radial artery is> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm.

Exclusion Criteria:

  1. The patient refused to join the study
  2. serious heart failure (Physicians identify insufficient cardiac output that may affect sacral blood flow development after surgery)
  3. Unconsciousness
  4. Bedridden for long time
  5. systemic lupus erythematosus(SLE), or other known autoimmune diseases
  6. The physician excludes the possibility of creating a wrist HDAVF before surgery
  7. Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF
  8. Choose a site other than the wrist for surgery
  9. Unexpected complications happen during the surgery that prevent the completion of a wrist HDAVF

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136859


Contacts
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Contact: Chih-Yang Chan, PhD +886972651147 chanchihyang@gmail.com
Contact: Po-Ya Chang, MsC +886975810806 poyachang0913@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital
Publications of Results:
Holzapfel GA. Collagen in arterial walls: biomechanical aspects. In: Collagen. Springer; 2008:285-324.

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05136859    
Other Study ID Numbers: 202006195RINC
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
hemodialysis
Inflammation
Arteriovenous Fistula
perivascular fat
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities