Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

University of Aarhus25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brain Injury Constipation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

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

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

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.

Data from ClinicalTrials.gov

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