Acute Salt Handling in Orthostatic Intolerance | NCT00581633

Studies
Acute Salt Handling in Orthostatic Intolerance

NCT00581633

Sponsor

Vanderbilt University

Status

Active, not recruiting

Last Update Posted

Oct 6, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Postural Tachycardia Syndrome
Orthostatic Tachycardia
Orthostatic Intolerance

Interventions

normal saline (0.9%)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Link
UL1RR024975	U.S. NIH Grant/Contract	View source
K23RR020783	U.S. NIH Grant/Contract	View source
P01HL056693	U.S. NIH Grant/Contract	View source

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Dec 22, 2007

First Submission Date that Met QC Criteria

Dec 22, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2025

Last Update Posted Date

Oct 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt UniversityPrincipal Investigator

Lead Sponsor

Vanderbilt UniversityOTHER

Collaborators

Name	Class
National Center for Research Resources (NCRR)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	saline infusion for sodium loading	Other: normal saline (0.9%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
normal saline (0.9%)	Other	liter normal saline over 30 minutes x 1 dose	1

Measure	Description	Time Frame
Urinary Na excretion		24h and then hourly post saline load

Measure	Description	Time Frame
Catecholamine levels		1 day

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satish R Raj, MD MSCI	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University		Nashville	Tennessee	37232	United States

Label	URL
Vanderbilt Autonomic Dysfunction Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D054972	Postural Orthostatic Tachycardia Syndrome
D054971	Orthostatic Intolerance
D013610	Tachycardia

Ancestor Terms

ID	Term
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided