Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Constipation Clinical Trial

Official title:

Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428790
• Other study ID #: ABITransitTimeHammel
• Status: Completed
• Phase: N/A
• First received: April 17, 2015
• Last updated: December 1, 2015
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• ABI:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Constipation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Hammel Neurocenter

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal transit time (GITT) [in days]		During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.	No
Secondary	Association between heart rate variability (HRV) and GITT	Linear regression with GITT as dependent variable, and high frequency power sepectral density analysis of the heart rate (HF) as the independent variable.	During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.	No