Preoperative Supine Time for Adrenal Venous Sampling

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

Detailed Description
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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.

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

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Procedure: 15-min supine time
* Procedure: 2-hour supine time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are clinically diagnosed as primary aldosteronism with ARR≥37 (PAC showed as pg/ml, renin showed as μIU/mL) and passed through PA confirmatory tests (PAC-post CCT>110pg/ml, PAC-post SSIT >80pg/ml, or PAC-post FST>60pg/ml). PAC: plasma aldosterone concentration; Patients with willing for AVS; Age 18 or above, male or female, with legal capacity. Exclusion Criteria: Patients with suspected adrenocortical carcinoma or pheochromocytoma; Patients with high risk of adrenal surgery; Patients have been subtyping to glucocorticoid-suppressible hyperaldosteronism or familial hyperaldosteronism type III; Patients were diagnosed as Cushing syndrome or subclinical Cushing syndrome; Patients were treated with glucocorticoids recently; Patients with whole body or venipuncture area infection; Patients with venous access thrombosis; Patients are allergic to iodine; Patients with X-ray contraindications; Patients with coagulation dysfunction; Patients are unable to cooperate and follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group(15-min supine group)<br>Participants in the experimental group will keep supine position for 15 minutes before AVS. | Procedure: 15-min supine time<br>* The length of preoperative supine time before AVS was 15 minutes.<br>|
| Active Comparator: control group(2-hour supine group)<br>Participants in the control group will keep supine position for 2 hours before AVS. | Procedure: 2-hour supine time<br>* The length of preoperative supine time before AVS was 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complete biochemical remission | Compare the rate of complete biochemical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium. According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes. The proportion of complete biochemical remission according to PASO consensus criteria. | At 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complete clinical remission | Compare the rate of complete clinical remission between two groups. The proportion of complete clinical remission according to PASO consensus criteria. Clinical outcomes were determined by the blood pressure response to treatment and the number and dosage of antihypertensive medications. | At 6 months of follow-up | 
| Successful catheterization rate | Intraoperative bilateral SI value was used to judge whether the blood collection cannula was successful. In the surgery absence of osyntropin, SI≥2 was used as the standard for successful blood collection and LI≥2 was used for judging the dominant side aldosterone secretion. | At baseline | 
| Adverse events | Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism, ect. | At 3 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adrenal venous sampling, preoperative supine time, primary aldosteronism, resistant hypertension