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

• Conditions: Sepsis; Fluid Therapy; Hypovolemia; Post-operative Hypovolemia

• Registration Number: NCT03178578
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-21
• Study Start: 2017-05-18
• Study First Submitted QC: 2017-06-03
• Study First Posted: 2017-06-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• The intensive care physician declines to participate.
• Expected survival < 24h

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of anticipated hemodynamic effects at completion of bolus	At completion of bolus	The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology

Secondary Outcome Measures

Name	Time	Method
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus	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
The hemodynamic effects of a fluid bolus at completion of bolus	At completion of bolus	The effect of the fluid bolus on urine output at completion of bolus will be described.
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 effect of the fluid bolus on urine output one hour after completion of the fluid bolus will be described.

Trial Locations

Locations (3)

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Danderyd, Sweden

Austin Hospital; 🇦🇺 Melbourne, Victoria, Australia