A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy

NCT ID: NCT03178578

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-18

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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Hypovolemia Sepsis Post-operative Hypovolemia Fluid Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the intensive care unit and prescribed a fluid bolus.

Exclusion Criteria

* The intensive care physician declines to participate.
* Expected survival \< 24h
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Hospital, Melbourne Australia

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Christer Svensen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christer Svensen, MD,PhD,Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Austin Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Danderyds sjukhus

Stockholm, Danderyd, Sweden

Site Status NOT_YET_RECRUITING

Södersjukhuset

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Australia Sweden

Central Contacts

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Maria Cronhjort, MD, PhD

Role: CONTACT

+466161000

Olof Wall, MD

Role: CONTACT

+468 123 58374

Facility Contacts

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Glenn Eastwood, A Prof

Role: primary

+61 3 9496 4835

Johan Mårtensson, MD, PhD

Role: backup

+61 3 9496 4835

Olof Wall, MD

Role: primary

+46812358374

Daniel Törnberg, MD, PhD

Role: backup

Maria Cronhjort, MD, PhD

Role: primary

+466161000

Christer Svensén, MD, PhD, Prof

Role: backup

+4686162226

Other Identifiers

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LNR/17/Austin/94

Identifier Type: -

Identifier Source: org_study_id

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