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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178578
• Other study ID #: LNR/17/Austin/94
• Status: Recruiting
• Start date: May 18, 2017
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: Karolinska Institutet
• Contact: Maria Cronhjort, MD, PhD
• Phone: +466161000
• Email: maria.cronhjort[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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 be included in the study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Therapy
• Hypovolemia
• Post-operative Hypovolemia
• Sepsis

Locations

Country	Name	City	State
Australia	Austin Hospital	Melbourne	Victoria
Sweden	Danderyds sjukhus	Stockholm	Danderyd
Sweden	Södersjukhuset	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Austin Hospital, Melbourne Australia, Danderyd Hospital

Countries where clinical trial is conducted

Australia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At completion of bolus
Secondary	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	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus
Secondary	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.	At completion of bolus
Secondary	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.	At one hour after completion of the fluid bolus