Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Completed

• Conditions: Brain Injury; Constipation

• Registration Number: NCT02428790
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Study Start: 2015-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.	Linear regression with GITT as dependent variable, and high frequency power sepectral density analysis of the heart rate (HF) as the independent variable.