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Autonomic Dysreflexia in Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01059370
First received: January 19, 2010
Last updated: October 15, 2012
Last verified: October 2012
History of Changes

January 19, 2010
October 15, 2012
December 2009
November 2011   (final data collection date for primary outcome measure)
Intervention induces 25 % raise in BP compared to baseline measurements. [ Time Frame: Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01059370 on ClinicalTrials.gov Archive Site
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Autonomic Dysreflexia in Spinal Cord Injury
Autonom Dysrefleksi Ved Rygmarvsskade

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Autonomic Dysfunction
  • Spinal Cord Injured
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.
Other Names:
  • Peristeen
  • Finometer Pro
Experimental: Autonomic dysrefleksia
Autonomic dysreflexia in SCI when emptying bowels or filling bladder
Intervention: Procedure: bowel emptying
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01059370
2009-0112
Yes
University of Aarhus
University of Aarhus
Not Provided
Study Chair: Søren Laurberg, Professor University of Århus
University of Aarhus
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP