Effect of Fluid Challenge on Intracranial Pressure
Primary Purpose
Fluid Challenge, Increased Intracranial Pressure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Measurement of optic nerve sheath diameter
Sponsored by
About this trial
This is an interventional diagnostic trial for Fluid Challenge focused on measuring optic nerve sheath diameter, fluid challenge
Eligibility Criteria
Inclusion Criteria:
- Patients with no known intracranial pathology.
- Patients with systolic blood pressure < 90 mmHg
- Patients with mean blood pressure < 65 mmHg
- Patients with tachycardia (heart rate 100 beats/min)
- Patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure.
- Patients with arterial lactate concentration > 2 mmol/L
Exclusion Criteria:
- Patients with known intracranial hypertension
- Patients in the early postpartum period
- Patients with severe mitral or aortic regurgitation
- Patients with cardiac arrhythmia
- Patients unable to be evaluated due to poor echogenicity
Sites / Locations
- Ondokuz Mayıs Universitesi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluid challenge
Arm Description
Fluid challenge effects on optic nerve sheath diameter
Outcomes
Primary Outcome Measures
The change in intracranial pressure associated with the fluid challenge
The change in intracranial pressure according to the optic nerve sheath diameter measurements.
Secondary Outcome Measures
The relationship between fluid responsiveness and the change in optic nerve sheath diameter
The fluid responsiveness associated with the change in optic nerve sheath diameter measurements
Full Information
NCT ID
NCT04928040
First Posted
June 9, 2021
Last Updated
January 16, 2022
Sponsor
Ondokuz Mayıs University
1. Study Identification
Unique Protocol Identification Number
NCT04928040
Brief Title
Effect of Fluid Challenge on Intracranial Pressure
Official Title
Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fluid challenge is frequently used in fluid management of critically ill patients. Assessing whether there is a preload reserve that can be used to increase the stroke volume by delivering a small amount of fluid in a short period of time. Optimization of fluid therapy is very important in intensive care patients. Inappropriate fluid therapy can cause significant morbidity and even mortality. Increased intracranial pressure is one of these important complications. In the present study, we planned to evaluate the effect of a fluid challenge on intracranial pressure by measuring the optic nerve sheath diameter (ONSD).
Detailed Description
The fluid challenge is a simple volume resuscitation evaluation method that provides an indication of the patient's likelihood of benefiting from an increase in the intravenous fluid volume. Both the fluid challenge and fluid responsiveness are evaluated by interpreting the change in hemodynamic parameters after 500 mL of crystalloid (or 250 mL of colloid) solution is infused over 10-15 min. This is done in an attempt to regulate the fluid therapy of hemodynamically unstable patients in order to prevent fluid overload. In the present study, we aim to investigate the effect of the fluid challenge maneuver on intracranial pressure in ICU patients with hemodynamic instability through measuring the optic nerve sheath diameter by ultrasonography.
Patients in the intensive care unit undergoing a fluid challenge were included in this prospective observational study. A fluid challenge is defined as a 500 mL crystalloid infusion administered over 10 min, and fluid responsiveness is defined as a subsequent increase in stroke volume of at least 15%. The ONSD and hemodynamic variables will be measured by ultrasonography before (T0), at the end (T1), and 30 min after the fluid challenge (T2). The primary outcome of the study is the change in intracranial pressure associated with the fluid challenge, and the secondary outcome is the relationship between fluid responsiveness and the change in ONSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Challenge, Increased Intracranial Pressure
Keywords
optic nerve sheath diameter, fluid challenge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluid challenge
Arm Type
Experimental
Arm Description
Fluid challenge effects on optic nerve sheath diameter
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of optic nerve sheath diameter
Intervention Description
The fluid challenge effects of optic nerve sheath diameter
Primary Outcome Measure Information:
Title
The change in intracranial pressure associated with the fluid challenge
Description
The change in intracranial pressure according to the optic nerve sheath diameter measurements.
Time Frame
Before, at the end, and 30 min after the fluid challenge.
Secondary Outcome Measure Information:
Title
The relationship between fluid responsiveness and the change in optic nerve sheath diameter
Description
The fluid responsiveness associated with the change in optic nerve sheath diameter measurements
Time Frame
Before, at the end, and 30 min after the fluid challenge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with no known intracranial pathology.
Patients with systolic blood pressure < 90 mmHg
Patients with mean blood pressure < 65 mmHg
Patients with tachycardia (heart rate 100 beats/min)
Patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure.
Patients with arterial lactate concentration > 2 mmol/L
Exclusion Criteria:
Patients with known intracranial hypertension
Patients in the early postpartum period
Patients with severe mitral or aortic regurgitation
Patients with cardiac arrhythmia
Patients unable to be evaluated due to poor echogenicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ozgur komurcu, 1
Organizational Affiliation
zgrkom@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ondokuz Mayıs Universitesi
City
Atakent
State/Province
Samsun
ZIP/Postal Code
55280
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Primary and secondary study outcomes
Citations:
PubMed Identifier
25204700
Citation
Hoste EA, Maitland K, Brudney CS, Mehta R, Vincent JL, Yates D, Kellum JA, Mythen MG, Shaw AD; ADQI XII Investigators Group. Four phases of intravenous fluid therapy: a conceptual model. Br J Anaesth. 2014 Nov;113(5):740-7. doi: 10.1093/bja/aeu300. Epub 2014 Sep 9.
Results Reference
background
PubMed Identifier
21508838
Citation
Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.
Results Reference
background
PubMed Identifier
21769456
Citation
Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.
Results Reference
background
PubMed Identifier
9201061
Citation
McGuire G, Crossley D, Richards J, Wong D. Effects of varying levels of positive end-expiratory pressure on intracranial pressure and cerebral perfusion pressure. Crit Care Med. 1997 Jun;25(6):1059-62. doi: 10.1097/00003246-199706000-00025.
Results Reference
background
Learn more about this trial
Effect of Fluid Challenge on Intracranial Pressure
We'll reach out to this number within 24 hrs