Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- Impact of PIE on AVF primary failure comparing the control group and the PIE group.
Study Overview
Brief Summary
A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.
The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.
We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.
Detailed Description
RECRUITING PERIOD: 20 months.
FOLLOW UP: From the first preoperative assessment visit for AVF up to 3 months after its creation.
METHODS:
After signing the informed consent, patients will be randomized through a centralized computer program to one of two groups of patients, PIE group versus control group.
In both groups of patients, a first physical examination of upper arm extremities and an initial doppler ultrasound will be performed, evaluating the anatomical and hemodynamic characteristics of the arteries and veins of both arms. At that time, a first surgical option of AVF will be indicated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent signature.
- •Age between 18 and 89 years.
- •Patients with advanced chronic kidney disease, stages IV-V, in pre-dialysis or prevalent HD patients, requiring new AVF.
Exclusion Criteria
- •Absence of adequate arteries and veins to allow autologous AVF. (The minimum gauges that will be considered in order to perform an autologous AVF are: artery caliber equal or greater than 1.6 mm and vein caliber equal or greater than 1,8 mm with a compressor).
- •Diagnosis of coagulopathy or hemoglobinopathy of any cause.
- •Patients who urgently need an AVF without the possibility of being 8 weeks on the surgical waiting list.
- •Impossibility to perform the physical exercise protocol due to physical or mental disabilities or lack of social support.
Outcomes
Primary Outcomes
Impact of PIE on AVF primary failure comparing the control group and the PIE group.
Time Frame: 12 weeks after AVF surgery (visit 6)
We will evaluate in both groups the primary failure rate. It will be evaluated during visit 6 (12 weeks after AVF creation). We expect a lower primary failure rate in the PIE group.
Secondary Outcomes
- Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise.(8 weeks follow up visit before surgery (visit 3))
- Impact of AVF evaluation with doppler ultrasound in the postoperative period in both groups, adding the usual isometric exercise with ball contraction in all patients.(12 weeks after AVF surgery (visit 6))
- Analysis of the optimal arterial and venous calibres to minimize the primary failure of AVF according to the individual risk factors in both groups of patients.(12 weeks after AVF surgery (visit 6))
- Percentage of candidate patients for autologous distal or proximal AVF in both groups.(1 week after AVF surgery (visit 4))
- Impact of nutritional-inflammatory status on AVF outcomes(12 weeks after AVF surgery (visit 6))
Investigators
Ines Aragoncillo
Nephrologist
Hospital General Universitario Gregorio Marañon