HypovolemiaNCT03178578
A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy
An observational study of Hypovolemia and Sepsis, run by Karolinska Institutet at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Sepsis, Post-operative Hypovolemia
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 May 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypovolemic critically ill patients in the intensive care unit.
Who may be able to join
- Patients admitted to the intensive care unit and prescribed a fluid bolus.
Who cannot join
- The intensive care physician declines to participate.
- Expected survival < 24h
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites, 2 recruiting
- Not yet recruiting
Danderyds sjukhus
Stockholm, Danderyd, 182 88
Olof Wall, MD, +46812358374, olof.wall@telia.com
Daniel Törnberg, MD, PhD, daniel.tornberg@sll.se
- Not yet recruiting
Södersjukhuset
Stockholm, 118 83
Maria Cronhjort, MD, PhD, +466161000, maria.cronhjort@sll.se
Christer Svensén, MD, PhD, Prof, +4686162226, christer.svensen@sll.se
Australia1 site, 1 recruiting
- Recruiting
Austin Hospital
Melbourne, Victoria
Glenn Eastwood, A Prof, +61 3 9496 4835, glenn.eastwood@austin.org.au
Johan Mårtensson, MD, PhD, +61 3 9496 4835, johan.martensson@austin.org.au
About this study
Official title: A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
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.
Read the detailed description
Intensive care unit patients often receive a fluid bolus during their ICU-stay. ICU doctors use a variety of clinical triggers when deciding whether or not to give a fluid bolus. However, the type of physiological triggers used and their correlation to the anticipated physiological response of the patient to an administered fluid bolus is not entirely clear.
The investigators will perform a prospective observational study to evaluate the triggers for, expected physiological and actual physiological response to fluid bolus therapy in the intensive care unit. Specifically, the investigators will assess which of the the physiological trigger(s) intensive care doctors use when deciding to give a fluid bolus; the expected physiological response to the fluid bolus by intensive care doctors; and, to what degree the patients actual physiological response 1 hour after a fluid bolus correlate with expectations.
This study will involve a survey of ICU physicians to determine the physiological trigger and expectations and a medical audit to ascertain the physiological response to a fluid bolus. The investigators will evaluate a single fluid bolus in 100 separate intensive care unit patients.
- Conditions
- Hypovolemia, Sepsis, Post-operative Hypovolemia, Fluid Therapy
- Keywords
- Fluid therapy
- Medical subject headings
- Hypovolemia, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At completion of bolus
Secondary outcomes (15)
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on blood pressure at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on blood pressure one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on heart rate at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on heart rate one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on cardiac index at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on cardiac index one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on CVP at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on CVP one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on ScVO2 or SvO2 at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on ScVO2 or SvO2 one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on lactate levels at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on lactate levels one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
The effect of the fluid bolus on urine output at completion of bolus will be described.
Measured: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
The effect of the fluid bolus on urine output one hour after completion of the fluid bolus will be described.
Measured: At one hour after completion of the fluid bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start18 May 2017
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Danderyd Hospital
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Christer Svensen, MD,PhD,Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178578
- Sponsor's protocol ID
- LNR/17/Austin/94
- Status last verified
- Sep 2019
- First submitted
- 21 Apr 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03178578
- Acronym / sponsor ID
- LNR/17/Austin/94
- Conditions
- Hypovolemia, Sepsis, Post-operative Hypovolemia, Fluid Therapy
- Keywords
- Fluid therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Austin Hospital, Melbourne Australia, Danderyd Hospital
- Study start
- 18 May 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intensive care unit patients often receive a fluid bolus during their ICU-stay. ICU doctors use a variety of clinical triggers when deciding whether or not to give a fluid bolus. However, the type of physiological triggers used and their correlation to the anticipated physiological response of the patient to an administered fluid bolus is not entirely clear.
The investigators will perform a prospective observational study to evaluate the triggers for, expected physiological and actual physiological response to fluid bolus therapy in the intensive care unit. Specifically, the investigators will assess which of the the physiological trigger(s) intensive care doctors use when deciding to give a fluid bolus; the expected physiological response to the fluid bolus by intensive care doctors; and, to what degree the patients actual physiological response 1 hour after a fluid bolus correlate with expectations.
This study will involve a survey of ICU physicians to determine the physiological trigger and expectations and a medical audit to ascertain the physiological response to a fluid bolus. The investigators will evaluate a single fluid bolus in 100 separate intensive care unit patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypovolemic critically ill patients in the intensive care unit.
Key inclusion criteria (1 listed)
- Patients admitted to the intensive care unit and prescribed a fluid bolus.
Key exclusion criteria (2 listed)
- The intensive care physician declines to participate.
- Expected survival < 24h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of anticipated hemodynamic effects at completion of bolus
Time frame: At completion of bolus
The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
15 secondary outcomes
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
The hemodynamic effects of a fluid bolus at completion of bolus
Time frame: At completion of bolus
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Time frame: At one hour after completion of the fluid bolus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christer Svensen, MD,PhD,Prof principal investigator
Karolinska Institutet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia and Sepsis, run by Karolinska Institutet at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Cronhjort, MD, PhD (+466161000, maria.cronhjort@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of anticipated hemodynamic effects at completion of bolus (time frame: At completion of bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.