Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT05911451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-19
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Access Surgery In Senior Hemodialysis Patients
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
OASIS
Brief Summary:
The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.
Detailed Description:
Objective: To compare surgical strategies for vascular access creation in elderly hemodialysis patients.
Hypothesis: Arteriovenous grafts and central venous catheters lead to fewer interventions, more quality of life, and lower health care costs than autologous arteriovenous fistulas.
Study design: Parallel group, multicenter randomized controlled trial.
Study population: Patients \>65 years with a life expectancy \<2 years who are expected to start hemodialysis treatment within 6 months or who have started hemodialysis treatment with a catheter in the past 6 months.
Study groups:
1. Autologous arteriovenous fistula creation
2. Arteriovenous graft implantation
3. Central venous catheter placement
Sample size calculation: 3x65 patients for superiority with multiplicity correction based on a clinically relevant difference of 0.80 interventions/year. Due to slow enrollment, follow-up time per participant was much longer than anticipated at trial initiation. After enrollment of 166 participants, calculations based on actual event and mortality rates showed that the trial had sufficient statistical power to detect a relative difference in event rate of 0.67, corresponding to an absolute difference below the minimal clinically relevant difference of 0.80 access-related interventions per year. Therefore, enrollment was closed at 166 participants.
Data analysis: Poisson regression analysis with time as off-set variable.
Hypothesis: Arteriovenous grafts and central venous catheters lead to fewer interventions, more quality of life, and lower health care costs than autologous arteriovenous fistulas.
Study design: Parallel group, multicenter randomized controlled trial.
Study population: Patients \>65 years with a life expectancy \<2 years who are expected to start hemodialysis treatment within 6 months or who have started hemodialysis treatment with a catheter in the past 6 months.
Study groups:
1. Autologous arteriovenous fistula creation
2. Arteriovenous graft implantation
3. Central venous catheter placement
Sample size calculation: 3x65 patients for superiority with multiplicity correction based on a clinically relevant difference of 0.80 interventions/year. Due to slow enrollment, follow-up time per participant was much longer than anticipated at trial initiation. After enrollment of 166 participants, calculations based on actual event and mortality rates showed that the trial had sufficient statistical power to detect a relative difference in event rate of 0.67, corresponding to an absolute difference below the minimal clinically relevant difference of 0.80 access-related interventions per year. Therefore, enrollment was closed at 166 participants.
Data analysis: Poisson regression analysis with time as off-set variable.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NL7933 | OTHER | Netherlands Trial Registry | View |