Clinical Trials Logo
  1. Home
  2. Hypotension
  3. NCT05839652
  4. Details
NCT05839652 Clinical Trial

Treatment of Orthostatic Hypotension in SCI

Hypotension Clinical Trial

— SCI  

Official title:
Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05839652
Other study ID # 1747301-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2023
Est. completion date June 30, 2026

Study information
Verified date April 2023
Source James J. Peters Veterans Affairs Medical Center
Contact Matt G. Maher, MS
Phone 9733243588
Email matt.maher@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - traumatic spinal cord injury - at least 12 months post injury - injury level of C1-T6 - AIS A, B or C - non-ambulatory - non-ventilator Exclusion Criteria: - Active psychiatric disorder - Stroke or cerebrovascular disease - Alzheimer's Disease or dementia - Unmanaged cardiac arrhythmias - Concurrent systemic, hepatic, or renal disease - Suspected or diagnosed malignancy - Neurological disease other than SCI - Self-reported history of three or more symptomatic episodes of AD per day

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

Locations
Country Name City State
United States James J Peters VA Medical Center Bronx New York
United States Kessler Foundation West Orange New Jersey

Sponsors (2)
Lead Sponsor Collaborator
James J. Peters Veterans Affairs Medical Center Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic blood pressure determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo 3 years
Secondary Cerebral blood flow velocity determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo 3 years
Secondary Symptoms of autonomic dysreflexia and orthostatic hypotension determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo 3 years
See also
  Status Clinical Trial Phase
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting NCT02016599 - Effects of Transitional Circulation in ELBW Infants
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Recruiting NCT02532270 - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring N/A
Completed NCT02437799 - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia N/A
Completed NCT02802683 - Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery Phase 4
Completed NCT01930227 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients N/A
Completed NCT02146898 - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery N/A
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Recruiting NCT01434251 - Treatment of Hypotension of Prematurity (TOHOP) N/A
Withdrawn NCT01183741 - Accuracy of Non-Invasive Blood Pressure Measurement in Adults Phase 3
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Withdrawn NCT00750516 - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Recruiting NCT05513066 - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed NCT04089644 - Manual vs Closed-loop Control of Mean Arterial Pressure N/A