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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03178578
• Collaborator: Austin Hospital, Melbourne Australia (Other), Danderyd Hospital (Other)
• Enrollment: 100
• Locations: 3
• Anticipated Duration (Months): 31.5
• Patients Per Site: 33.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Outcome Measures

Primary Outcome Measures

1. Accuracy of anticipated hemodynamic effects at completion of bolus [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Austin Hospital	Melbourne	Victoria	Australia
2	Danderyds sjukhus	Stockholm	Danderyd	Sweden	182 88
3	Södersjukhuset	Stockholm		Sweden	118 83

Sponsors and Collaborators

• Karolinska Institutet
• Austin Hospital, Melbourne Australia
• Danderyd Hospital

Investigators

• Principal Investigator: Christer Svensen, MD,PhD,Prof, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christer Svensen, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03178578
• Other Study ID Numbers: LNR/17/Austin/94
• First Posted: Jun 7, 2017
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christer Svensen, Professor, Karolinska Institutet: Fluid therapy
• Additional relevant MeSH terms: Hypovolemia

Study Results

No Results Posted as of Sep 4, 2019