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

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ClinicalTrials.gov Identifier: NCT03178578
Recruitment Status : Unknown
Verified June 2017 by Christer Svensen, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
Austin Hospital, Melbourne Australia
Danderyd Hospital
Information provided by (Responsible Party):
Christer Svensen, 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.

Condition or disease
Hypovolemia Sepsis Post-operative Hypovolemia Fluid Therapy

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypovolemic critically ill patients in the intensive care unit.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178578


Contacts
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Contact: Maria Cronhjort, MD, PhD +466161000 maria.cronhjort@sll.se
Contact: Olof Wall, MD +468 123 58374 olof.wall@sll.se

Locations
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Australia, Victoria
Austin Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Glenn Eastwood, A Prof    +61 3 9496 4835    glenn.eastwood@austin.org.au   
Contact: Johan Mårtensson, MD, PhD    +61 3 9496 4835    johan.martensson@austin.org.au   
Principal Investigator: Rinaldo Bellomo, MD, Prof         
Sweden
Danderyds sjukhus Not yet recruiting
Stockholm, Danderyd, Sweden, 182 88
Contact: Olof Wall, MD    +46812358374    olof.wall@telia.com   
Contact: Daniel Törnberg, MD, PhD       daniel.tornberg@sll.se   
Principal Investigator: Olof Wall, MD         
Sub-Investigator: Daniel Törnberg, MD, PhD         
Södersjukhuset Not yet recruiting
Stockholm, Sweden, 118 83
Contact: Maria Cronhjort, MD, PhD    +466161000    maria.cronhjort@sll.se   
Contact: Christer Svensén, MD, PhD, Prof    +4686162226    christer.svensen@sll.se   
Sub-Investigator: Maria Cronhjort, MD, PhD         
Sub-Investigator: Eva Joelsson-Alm, MD, PhD         
Principal Investigator: Christer Svensén, MD, PhD, Prof         
Sponsors and Collaborators
Karolinska Institutet
Austin Hospital, Melbourne Australia
Danderyd Hospital
Investigators
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Principal Investigator: Christer Svensen, MD,PhD,Prof Karolinska Institutet

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Responsible Party: Christer Svensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03178578     History of Changes
Other Study ID Numbers: LNR/17/Austin/94
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christer Svensen, Karolinska Institutet:
Fluid therapy

Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes