Trial · NCT03365414
A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
NCT03365414, Phase 3, Withdrawn, University of Alberta
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS. Trials, record NCT03365414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03365414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
- NCT number
- NCT03365414
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Alberta
- Conditions
- Postural Orthostatic Tachycardia Syndrome
- Interventions
- Albumin (Human) 5%, USP, Normal Saline 0.9% Infusion Solution Bag
- First posted
- 2017-12-07
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of Orthostatic Intolerance | Change in Orthostatic Symptom Grading Scale (OSGS) scores from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration). | Self-reported severity of orthostatic intolerance assessed by the Orthostatic Symptom Grading Scale (OSGS) scores. Recorded daily. Each item is scored 0-4 (0= lowest severity; 4=greatest severity), yielding a total between 0 and 25. |
| Secondary | Disability Assessment | Weekly through study completion, 16 week duration | The Health Assessment Questionnaire (HAQ) score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do). |
| Secondary | Degree of cardiovascular improvement - Heart rate | Changes in heart rate (BPM) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration). | Degree of improvement from baseline in the severity of tachycardia (beats per minute) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture. |
| Secondary | Degree of cardiovascular improvement - Pulse | Changes in blood pressure (mm Hg) from baseline to end of first arm (1-4 weeks), from end of washout (5-8 weeks) to end of second arm (9-12 weeks) and at end of study (16 week duration). | Degree of improvement from baseline in the pulse pressure (mm Hg) on a 10-minute head up tilt table test (HUTT). The tilt table test will be performed at baseline and at the end-points of each arm of the study to measure degree of heart rate increment and pulse pressure reduction within 10 minutes of assuming an upright posture. |
| Secondary | Change in maximal exercise capacity - Cardiopulmonary exercise testing | Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration). | Cardiopulmonary exercise testing (CPX) using breath by breath gas-analysis measures variables related to cardiorespiratory function, including expiratory ventilation and pulmonary gas exchange (oxygen uptake (VO2) and carbon dioxide (VCO2).The standard expression of aerobic working capacity is the maximum VO2. VO2 max reached during a symptom-limited incremental CPX protocol is commonly expressed as O2 per kg-1 per min -1. |
| Secondary | Change in maximal exercise capacity - Electrocardiogram | Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration). | Electrocardiogram (ECG) measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise. |
| Secondary | Change in maximal exercise capacity - Heart rate | Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration). | Pulse measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise. |
| Secondary | Change in maximal exercise capacity - Blood Pressure | Changes in aerobic capacity between baseline and end of first arm (1-4 weeks), and end of washout (5-8 weeks) to end of second arm (9-12 weeks). Follow-up data at end of study (16 week duration). | Blood pressure measures allows for quantitatively linking metabolic, cardiovascular and pulmonary responses to exercise. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03365414
GET https://conductscience.org/api/trials/v1/NCT03365414/registered