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Clinical Trials/NCT03178578
NCT03178578
Unknown
Not Applicable

A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit

Karolinska Institutet3 sites in 2 countries100 target enrollmentMay 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
Karolinska Institutet
Enrollment
100
Locations
3
Primary Endpoint
Accuracy of anticipated hemodynamic effects at completion of bolus
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 18, 2017
End Date
January 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christer Svensen

Professor

Karolinska Institutet

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (3)

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