Effect of Fluid Challenge on Intracranial Pressure

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT04928040
Collaborator
(none)
60
1
1
6.8
8.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measurement of optic nerve sheath diameter
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge
Actual Study Start Date :
Jun 22, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 16, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The change in intracranial pressure associated with the fluid challenge [Before, at the end, and 30 min after the fluid challenge.]

    The change in intracranial pressure according to the optic nerve sheath diameter measurements.

Secondary Outcome Measures

  1. The relationship between fluid responsiveness and the change in optic nerve sheath diameter [Before, at the end, and 30 min after the fluid challenge.]

    The fluid responsiveness associated with the change in optic nerve sheath diameter measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ondokuz Mayıs Universitesi Atakent Samsun Turkey 55280

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: ozgur komurcu, 1, zgrkom@gmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ozgur Komurcu, Assistant professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT04928040
Other Study ID Numbers:
  • 2020/436
First Posted:
Jun 16, 2021
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
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 Ozgur Komurcu, Assistant professor, Ondokuz Mayıs University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022