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Acute Salt Handling in Orthostatic Intolerance

Acute Renal Salt Handling in Orthostatic Intolerance

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00581633
Enrollment
30
Registered
2007-12-27
Start date
2007-02-28
Completion date
2029-12-31
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Intolerance, Orthostatic Tachycardia, Postural Tachycardia Syndrome

Keywords

saline, sodium, kidney, tachycardia

Brief summary

The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.

Detailed description

Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt & water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.

Interventions

liter normal saline over 30 minutes x 1 dose

Sponsors

National Center for Research Resources (NCRR)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)

Exclusion criteria

* Overt or acute cause for orthostatic tachycardia * Hypertension (BP\>145/95 or need for anti-hypertensive medications) * QRS duration \> 120 msec on EKG * Pregnancy

Design outcomes

Primary

MeasureTime frame
Urinary Na excretion24h and then hourly post saline load

Secondary

MeasureTime frame
Catecholamine levels1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026