Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

University of Aarhus0 sites25 target enrollmentMay 2015

ConditionsBrain Injury Constipation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injury
Sponsor: University of Aarhus
Enrollment: 25
Primary Endpoint: Gastrointestinal transit time (GITT) [in days]
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.

The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

November 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
•or Stroke
•or Anoxic brain injury
•Ability to swallow the capsules used to assess GITT
•Ability to give meaningful informed consent to participate in the study

Exclusion Criteria

•Major abdominal disorders
•Severe acute comorbidity
•Known cancer
•Pregnancy
•Known autonomic neuropathy
•Other known neurological disorder

Outcomes

Primary Outcomes

Gastrointestinal transit time (GITT) [in days]

Time Frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.

Secondary Outcomes

Association between heart rate variability (HRV) and GITT(During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.)