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

September 3, 2019 updated by: Christer Svensen, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
  • Sweden
      • Stockholm, Sweden, 118 83
        • Not yet recruiting
        • Södersjukhuset
        • Contact:
        • 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:
        • Contact:
        • Principal Investigator:
          • Olof Wall, MD
        • Sub-Investigator:
          • Daniel Törnberg, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At completion of bolus

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danderyd Hospital
Austin Hospital, Melbourne Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christer Svensen, MD,PhD,Prof, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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