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

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Recruiting
      • Austin Hospital
      • Contact: Glenn Eastwood, A Prof; Phone Number: +61 3 9496 4835; Email: glenn.eastwood@austin.org.au
      • Contact: Johan Mårtensson, MD, PhD; Phone Number: +61 3 9496 4835; Email: johan.martensson@austin.org.au
      • Principal Investigator: Rinaldo Bellomo, MD, Prof
• Sweden
  • Stockholm, Sweden, 118 83
    • Not yet recruiting
    • Södersjukhuset
    • Contact: Christer Svensén, MD, PhD, Prof; Phone Number: +4686162226; Email: christer.svensen@sll.se
    • Sub-Investigator: Maria Cronhjort, MD, PhD
    • Sub-Investigator: Eva Joelsson-Alm, MD, PhD
    • Principal Investigator: Christer Svensén, MD, PhD, Prof
  • Danderyd
    • Stockholm, Danderyd, Sweden, 182 88
      • Not yet recruiting
      • Danderyds Sjukhus
      • Contact: Olof Wall, MD; Phone Number: +46812358374; Email: olof.wall@telia.com
      • Contact: Daniel Törnberg, MD, PhD; Email: daniel.tornberg@sll.se
      • Principal Investigator: Olof Wall, MD
      • Sub-Investigator: Daniel Törnberg, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hypovolemic critically ill patients in the intensive care unit.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Danderyd Hospital; Austin Hospital, Melbourne Australia
• Investigators: Principal Investigator: Christer Svensen, MD,PhD,Prof, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2017
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: June 3, 2017
• First Posted (ACTUAL): June 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Fluid therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: LNR/17/Austin/94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No