Clinical trial NCT03178578: A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy
Official title: A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypovolemia
Sepsis
Post-operative Hypovolemia
Fluid Therapy
Keywords: Fluid therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Austin Hospital, Melbourne Australia
name: Danderyd Hospital
First posted: 2017-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypovolemic critically ill patients in the intensive care unit.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of anticipated hemodynamic effects at completion of bolus
timeFrame: At completion of bolus
Secondary outcomes:
measure: Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
measure: The hemodynamic effects of a fluid bolus at completion of bolus
timeFrame: At completion of bolus
measure: The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
timeFrame: At one hour after completion of the fluid bolus
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
state: Danderyd
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Christer Svensen, MD,PhD,Prof
role: PRINCIPAL_INVESTIGATOR
References: