NCT05658705

Preoperative Supine Time for Adrenal Venous Sampling

Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aim to understand whether the length of preoperative supine time would affect the AVS outcome.

Detailed description

Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for 5% of hypertensive patients and 17-23% in patients with resistant hypertension. Compared to the primary hypertension, PA is more prone to cause severe organ damage and even early death. Adrenal venous sampling (AVS) is an effective confirmatory test for subtyping unilateral and bilateral adrenal hyperplasia, helping doctors to make an accurate decision between surgery or medication. Supine in bed before AVS is recommended for a desirable result of AVS according to guidelines. However, investigating study about the most optimal preoperative supine time before AVS is lacking. This is a single-center prospective randomized controlled study. 120 patients diagnosed as PA and with willing for further AVS examination will be included. Participants will be randomly allocated to 15-min supine time group or 2-hours supine time group. The primary outcomes are the degrees of clinical and laboratory remission (blood pressure, type and dose of antihypertensive drugs, serum potassium, orthostatic ARR). The secondary outcomes are the technical success rate and adverse event of AVS (selective index≥2 is considered as successful surgery without corticotropin stimulate). Discussion: Primary aldosteronism is an intractable public health problem, and many techniques including AVS have been developed to correctly identify this disease. This study will help to understand whether the length of preoperative supine time would affect the diagnostic efficacy of AVS, and thus help to formulate a more reasonable AVS procedure.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
PROCEDURE	15-min supine time	The length of preoperative supine time before AVS was 15 minutes.
PROCEDURE	2-hour supine time	The length of preoperative supine time before AVS was 2 hours.

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-03-29
• Completion: 2025-03-29
• First posted: 2022-12-21
• Last updated: 2024-04-26

Locations

1 site across 1 country: China