Effect of Fluid Challenge on Intracranial Pressure

Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge

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).

Study Overview

• Status: Completed
• Conditions: Fluid Challenge; Increased Intracranial Pressure
• Intervention / Treatment: Diagnostic test: Measurement of optic nerve sheath diameter

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun
    • Atakent, Samsun, Turkey, 55280
      • Ondokuz Mayıs Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with no known intracranial pathology.
2. Patients with systolic blood pressure < 90 mmHg
3. Patients with mean blood pressure < 65 mmHg
4. Patients with tachycardia (heart rate 100 beats/min)
5. 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.
6. Patients with arterial lactate concentration > 2 mmol/L

Exclusion Criteria:

1. Patients with known intracranial hypertension
2. Patients in the early postpartum period
3. Patients with severe mitral or aortic regurgitation
4. Patients with cardiac arrhythmia
5. Patients unable to be evaluated due to poor echogenicity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluid challenge; Fluid challenge effects on optic nerve sheath diameter	Diagnostic test: Measurement of optic nerve sheath diameter; The fluid challenge effects of optic nerve sheath diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in intracranial pressure associated with the fluid challenge	The change in intracranial pressure according to the optic nerve sheath diameter measurements.	Before, at the end, and 30 min after the fluid challenge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before, at the end, and 30 min after the fluid challenge.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: ozgur komurcu, 1, zgrkom@gmail.com

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: optic nerve sheath diameter, fluid challenge
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension
• Other Study ID Numbers: 2020/436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Primary and secondary study outcomes

Drug and device information, study documents

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