A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy
1 other identifier
observational
100
2 countries
3
Brief Summary
This prospective observational study aims to (i) asses intensive care doctors trigger for and the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients admitted to the intensive care unit will be included in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2017
CompletedStudy Start
First participant enrolled
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedSeptember 4, 2019
September 1, 2019
2.5 years
April 21, 2017
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of anticipated hemodynamic effects at completion of bolus
The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
At completion of bolus
Secondary Outcomes (15)
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
At one hour after completion of the fluid bolus
- +10 more secondary outcomes
Eligibility Criteria
Hypovolemic critically ill patients in the intensive care unit.
You may qualify if:
- Patients admitted to the intensive care unit and prescribed a fluid bolus.
You may not qualify if:
- The intensive care physician declines to participate.
- Expected survival \< 24h
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Austin Hospital, Melbourne Australiacollaborator
- Danderyd Hospitalcollaborator
Study Sites (3)
Austin Hospital
Melbourne, Victoria, Australia
Danderyds sjukhus
Stockholm, Danderyd, 182 88, Sweden
Södersjukhuset
Stockholm, 118 83, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christer Svensen, MD,PhD,Prof
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 21, 2017
First Posted
June 7, 2017
Study Start
May 18, 2017
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
September 4, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share