Autonomic Dysreflexia in Spinal Cord Injury

Autonomic Dysfunction Clinical Trial

Official title:

Autonom Dysrefleksi Ved Rygmarvsskade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059370
• Other study ID #: 2009-0112
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: October 15, 2012
• Start date: December 2009
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.

2. At least one year post injury.

3. 18 years or older.

4. Informed consent.

Exclusion Criteria:

1. Usage of prophylactic anti-autonomic dysreflexia medication.

2. Pregnant or breastfeeding.

3. People who is not able to follow the sudy protocol.

4. No former major surgery in the abdomen or pelvic region.

5. No former radiotherapy in the pelvic region.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Primary Dysautonomias
• Spinal Cord Injured

Intervention

Procedure:
• bowel emptying
Bowel is emptied using Peristeen® irrigation system one day, by digital stimulation another trial day or filling the bladder with saline water on a third trial day. BP is measured by Finometer Pro®, respiration frequency by BIOPACK and skin conductivity measured by Biopack and nor-epinephrine and epinephrine are measured in plasma three times during each examination.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention induces 25 % raise in BP compared to baseline measurements.		Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.	Yes