Clinical trial NCT03974737: CRI in POTS in Adolescents
Official title: Evaluation of the Compensatory Reserve Index and Psychosocial Factors in Pediatric Autonomic Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Orthostatic Tachycardia Syndrome
Keywords: POTS
Postural Orthostatic Tachycardia Syndrome
Dysautonomia
CRI
Compensatory Reserve Index
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2019-06-05
Enrollment: 77
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adolescents with POTS 12-21 years old and adolescents without POTS 12-21 years old. One parent will be required to attend the study visit.

Brief summary: The investigators aim to study whether the Compensatory Reserve Index (CRI) (an FDA approved device that assesses intravascular volume) can be used to evaluate severity of Postural Orthostatic Tachycardia Syndrome (POTS) and whether the CRI value has a correlation with severity of psychosocial symptoms and functional impairment associated with POTS.

Detailed description: Autonomic dysfunction (or dysautonomia) describes several medical conditions linked to the autonomic nervous system. One of these is Postural Orthostatic Tachycardia Syndrome (POTS). In pediatric populations, symptoms of autonomic dysfunction include an increase in heart rate when standing up (tachycardia), dizziness, nausea, vomiting, fatigue, headaches, abdominal discomfort, and sleep disturbances. POTS is specifically characterized by orthostatic intolerance and a forty beats per minute (bpm) increase in heart rate upon standing. The etiology of POTS is poorly understood, and there is limited literature on the management of POTS in pediatric populations. In the U.S., POTS is estimated to affect 1-3 million people.

The ability of the CRI algorithm to accurately distinguish individuals with varying tolerances to reduced central blood volume can be attributed to a unique function of the algorithm, which analyzes and compares the entirety of each waveform in a window of time to trend subtle features that correspond with varying degrees of central volume loss. CRI can also detect vascular changes associated with postural orthostatic tachycardia syndrome. CRI will be evaluated in subjects at supine and standing positions along with traditional orthostatic measures.

Following CRI measurements, subjects and their parents will be asked to complete a series of surveys to assess their psychosocial symptoms and functional impairment. The CRI measurement and survey completion will occur over the course of one clinic visit.

Eligibility criteria: Inclusion Criteria:

* Adolescent participants must be aged 12 to 21 years (inclusive).
* Each participant must have at one parent/legal guardian who can provide informed consent for the adolescent and participate in the study by completing study questionnaires.
* Moreover, as the majority of study measures are only validated for use in English, only English-speaking patients will be included in this study.

Exclusion Criteria:

* Adolescents will be excluded from the study if they are outside the age range of 12-21 years old
* Adolescents who are wards of the state
* Adolescents who are incarcerated
* Adolescents who are decisionally impaired (i.e., have difficulty understanding the protocol during the consent process, and/or research team member is unsure of individual's ability to correctly identify whether the research study would need to stop or not)
* Adolescents who object at any time to participating in the study
* Adolescents who have a pacemaker
* Adolescents who are taking beta blocker medications
* Adolescents who were were hospitalized in the past month for serious medical conditions affecting their cardiopulmonary system (note, this does not include recent hospitalizations for trauma or burns).
* Adolescents will also be excluded if their parent/legal guardian(s) are unwilling to participate in the study and/or do not have legal custody of the adolescent participant.
* Adolescents who do not speak English will be excluded from the study as majority of the study measures are only validated in English.

Primary outcomes:
measure: Change in Compensatory Reserve Index (CRI) Values
timeFrame: Minute 1 through minute 20
measure: Physical Symptoms Score as assessed by a Survey
timeFrame: 1 day (study visit)
measure: Frequency of Anxiety in Days as assessed by a Survey
timeFrame: 1 day (study visit)
measure: Hypermobility as evaluated by the Beighton scale
timeFrame: 1 day (study visit)
measure: Frequency of Feelings of Stress in Days as assessed by a survey
timeFrame: 1 day (study visit)
measure: Frequency of difficulty with sleep as assessed by a survey
timeFrame: 1 day (study visit)
measure: Revised Child Anxiety and Depression Scale (RCADS and RCADS-P)
timeFrame: 1 day (study visit)
measure: Functional disability inventory (FDI)
timeFrame: 1 day (study visit)
measure: Social Connectedness Scale
timeFrame: 1 day (study visit)
measure: Friendship scale
timeFrame: 1 day (study visit)
measure: Frequency of friendship contact
timeFrame: 1 day (study visit)
measure: Family Assessment Device General Functioning scale (GFS)
timeFrame: 1 day (study visit)
measure: Sexual maturity Rating (Tanner stage)
timeFrame: 1 day (study visit)
measure: Parent Behavior Adult Responses to Children's Symptoms (ARCS)
timeFrame: 1 day (study visit)
measure: Parent Mental Health- PHQ-9
timeFrame: 1 day (study visit)
measure: Parent Mental Health- GAD-7
timeFrame: 1 day (study visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Clio Pitula, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Johnson JN, Mack KJ, Kuntz NL, Brands CK, Porter CJ, Fischer PR. Postural orthostatic tachycardia syndrome: a clinical review. Pediatr Neurol. 2010 Feb;42(2):77-85. doi: 10.1016/j.pediatrneurol.2009.07.002.
citation: Kizilbash SJ, Ahrens SP, Bruce BK, Chelimsky G, Driscoll SW, Harbeck-Weber C, Lloyd RM, Mack KJ, Nelson DE, Ninis N, Pianosi PT, Stewart JM, Weiss KE, Fischer PR. Adolescent fatigue, POTS, and recovery: a guide for clinicians. Curr Probl Pediatr Adolesc Health Care. 2014 May-Jun;44(5):108-33. doi: 10.1016/j.cppeds.2013.12.014.
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citation: Kritzberger CJ, Antiel RM, Wallace DP, Zacharias JD, Brands CK, Fischer PR, Harbeck-Weber C. Functional disability in adolescents with orthostatic intolerance and chronic pain. J Child Neurol. 2011 May;26(5):593-8. doi: 10.1177/0883073810390366. Epub 2011 Feb 7.
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citation: Bruce BK, Weiss KE, Harrison TE, Allman DA, Petersen MA, Luedkte CA, Fischer PR. Interdisciplinary Treatment of Maladaptive Behaviors Associated with Postural Orthostatic Tachycardia Syndrome (POTS): A Case Report. J Clin Psychol Med Settings. 2016 Jun;23(2):147-59. doi: 10.1007/s10880-015-9438-3.
citation: Lewis I, Pairman J, Spickett G, Newton JL. Clinical characteristics of a novel subgroup of chronic fatigue syndrome patients with postural orthostatic tachycardia syndrome. J Intern Med. 2013 May;273(5):501-10. doi: 10.1111/joim.12022. Epub 2013 Jan 7.
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citation: Moulton SL, Mulligan J, Grudic GZ, Convertino VA. Running on empty? The compensatory reserve index. J Trauma Acute Care Surg. 2013 Dec;75(6):1053-9. doi: 10.1097/TA.0b013e3182aa811a.