Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02428790

Enrollment

Registered

2015-04-29

Start date

2015-05-31

Completion date

2015-11-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Constipation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.

Outcome results